Oncopeptides（ONCOS）株式概要Oncopeptides AB（publish）は、バイオテクノロジー企業で、米国、欧州、および国際的に、治療が困難な血液疾患に対する標的療法の研究、開発、商業化に従事している。 詳細ONCOS ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性5/6配当金0/6報酬収益は年間45.53%増加すると予測されています 過去5年間の収益は年間45.2%増加しました。 リスク分析株式の流動性は非常に低い 過去1年間で株主の希薄化は大幅に進んだ 現在は利益が出ておらず、今後3年間で利益が出る見込みはない 意味のある時価総額がありません ( SEK624M )すべてのリスクチェックを見るONCOS Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW474,563 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINRODA474,563 investors already sharing narrativesYour Fair ValueSEK Current PriceSEK 1.7242.1% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-2b543m2016201920222025202620282031Revenue SEK 543.3mEarnings SEK 97.9mAdvancedSet Fair ValueView all narrativesOncopeptides AB (publ) 競合他社4basebioSymbol: AIM:4BBMarket cap: UK£85.5mBioventixSymbol: AIM:BVXPMarket cap: UK£78.4mProBiotix HealthSymbol: OFEX:PBXMarket cap: UK£15.0mArecor TherapeuticsSymbol: AIM:ARECMarket cap: UK£22.5m価格と性能株価の高値、安値、推移の概要Oncopeptides過去の株価現在の株価SEK 1.7252週高値SEK 6.5452週安値SEK 1.68ベータ-1.331ヶ月の変化0%3ヶ月変化n/a1年変化-64.57%3年間の変化n/a5年間の変化-96.12%IPOからの変化-98.67%最新ニュースお知らせ • Jun 17Oncopeptides AB (Publ) Announces Enrollment of First Patient in Oncopeptides' Glioblastoma StudyOncopeptides AB (publ) announced that the first patient has been enrolled in the clinical "Window-of-Opportunity" (WoO) study evaluating its proprietary Peptide Drug Conjugate (PDC) platform in glioblastoma. The WoO study, named OP-701 (INSULA), represents the first clinical evaluation of a PDC in glioblastoma, marking a major strategic milestone as Oncopeptides expands its core technology platform beyond multiple myeloma. The focused trial will enroll approximately 10 patients to provide initial human proof-of-concept to assess that the company's technology successfully penetrates the human blood-brain barrier (BBB) in glioblastoma patients and have cytotoxic (cell killing) activity in tumor cells. The BBB remains the primary clinical obstacle and causes most traditional oncological drugs to fail in this disease. By utilizing an approved drug from Oncopeptides' platform as a "clinical probe," the study employs an innovative and highly efficient design to capture drug activity directly within the tumor tissue from patients scheduled for surgery for recurrent disease. This approach aims to validate the underlying biological mechanism in a rapid, cost-efficient manner before advancing a PDC asset into formal dose-finding and potential further clinical trials. Glioblastoma is the most aggressive and devastating form of brain cancer, characterized by rapid tumor growth, invariable relapse, and a total lack of curative options, with a median survival rate of just 12–15 months. The global glioblastoma market represents a profound unmet medical need and is estimated to be worth more than 8 billion USD by 2035. Oncopeptides' PDC molecules are believed to be uniquely equipped to pass the blood-brain barrier due to their small size and lipophilicity, entering the target cancer cells freely to deliver their cytotoxic payload directly where it is needed. The trial is conducted at Oslo University Hospital in Norway.Breakeven Date Change • Jun 08Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.お知らせ • May 22Oncopeptides AB Announces Publication of Phase 2 Bridge Study Results for Pepaxti in Relapsed Refractory Multiple Myeloma Patients with Renal ImpairmentOncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, announced the publication of the results from the Phase 2 BRIDGE (OP-107) clinical study in the peer-reviewed journal Clinical Lymphoma, Myeloma and Leukemia. The prospective, open-label study evaluated the pharmacokinetics (PK), safety, and efficacy of Pepaxti (melflufen) plus dexamethasone in relapsed, refractory multiple myeloma (RRMM) patients with moderate-to-severe renal impairment (RI). Patients with renal insufficiency represent roughly half of all myeloma diagnoses and typically suffer from poorer long-term outcomes and limited clinical options. The final analyses demonstrate that while systemic exposure to the active metabolite melphalan varies based on baseline kidney function, a reduced melflufen starting dose of 30 mg in patients with moderate renal impairment delivers a consistent safety profile, treatment responses, and survival measures aligned with prior trials conducted in less selected populations. Furthermore, exploratory data gathered across the treatment cycles showed that renal function remained stable or slightly improved during therapy, suggesting that Pepaxti does not adversely impact the kidneys at the studied doses. Validated dose optimization: The PK data directly validate the clinical use and efficacy of a 30 mg Pepaxti starting dose for patients with moderate renal impairment (eGFR =30 to <45 mL/min/1.73 m²). Sustained efficacy in fragile populations: Patients with moderate renal impairment achieved an Overall Response Rate (ORR) of 47.6% in Cohort 1a (40 mg starting dose) and 70.0% in Cohort 1b (30 mg starting dose), with a median progression-free survival (PFS) of 8.6 months and 7.7 months, respectively. No new safety signals: Despite advanced renal impairment and high treatment exposure, the safety profile was well-characterized and manageable. The most frequently reported treatment-emergent adverse events were hematological (thrombocytopenia, anemia, and neutropenia), which is consistent with previous clinical trials. The full article, titled "BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function," is available online via Clinical Lymphoma, Myeloma and Leukemia. Pepaxti (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.Breakeven Date Change • May 20Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.お知らせ • Mar 18Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 129,283,736 Price\Range: SEK 1.55 Transaction Features: Rights Offeringお知らせ • Feb 19+ 4 more updatesOncopeptides AB (publ) to Report Q2, 2026 Results on Aug 27, 2026Oncopeptides AB (publ) announced that they will report Q2, 2026 results on Aug 27, 2026最新情報をもっと見るRecent updatesお知らせ • Jun 17Oncopeptides AB (Publ) Announces Enrollment of First Patient in Oncopeptides' Glioblastoma StudyOncopeptides AB (publ) announced that the first patient has been enrolled in the clinical "Window-of-Opportunity" (WoO) study evaluating its proprietary Peptide Drug Conjugate (PDC) platform in glioblastoma. The WoO study, named OP-701 (INSULA), represents the first clinical evaluation of a PDC in glioblastoma, marking a major strategic milestone as Oncopeptides expands its core technology platform beyond multiple myeloma. The focused trial will enroll approximately 10 patients to provide initial human proof-of-concept to assess that the company's technology successfully penetrates the human blood-brain barrier (BBB) in glioblastoma patients and have cytotoxic (cell killing) activity in tumor cells. The BBB remains the primary clinical obstacle and causes most traditional oncological drugs to fail in this disease. By utilizing an approved drug from Oncopeptides' platform as a "clinical probe," the study employs an innovative and highly efficient design to capture drug activity directly within the tumor tissue from patients scheduled for surgery for recurrent disease. This approach aims to validate the underlying biological mechanism in a rapid, cost-efficient manner before advancing a PDC asset into formal dose-finding and potential further clinical trials. Glioblastoma is the most aggressive and devastating form of brain cancer, characterized by rapid tumor growth, invariable relapse, and a total lack of curative options, with a median survival rate of just 12–15 months. The global glioblastoma market represents a profound unmet medical need and is estimated to be worth more than 8 billion USD by 2035. Oncopeptides' PDC molecules are believed to be uniquely equipped to pass the blood-brain barrier due to their small size and lipophilicity, entering the target cancer cells freely to deliver their cytotoxic payload directly where it is needed. The trial is conducted at Oslo University Hospital in Norway.Breakeven Date Change • Jun 08Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.お知らせ • May 22Oncopeptides AB Announces Publication of Phase 2 Bridge Study Results for Pepaxti in Relapsed Refractory Multiple Myeloma Patients with Renal ImpairmentOncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, announced the publication of the results from the Phase 2 BRIDGE (OP-107) clinical study in the peer-reviewed journal Clinical Lymphoma, Myeloma and Leukemia. The prospective, open-label study evaluated the pharmacokinetics (PK), safety, and efficacy of Pepaxti (melflufen) plus dexamethasone in relapsed, refractory multiple myeloma (RRMM) patients with moderate-to-severe renal impairment (RI). Patients with renal insufficiency represent roughly half of all myeloma diagnoses and typically suffer from poorer long-term outcomes and limited clinical options. The final analyses demonstrate that while systemic exposure to the active metabolite melphalan varies based on baseline kidney function, a reduced melflufen starting dose of 30 mg in patients with moderate renal impairment delivers a consistent safety profile, treatment responses, and survival measures aligned with prior trials conducted in less selected populations. Furthermore, exploratory data gathered across the treatment cycles showed that renal function remained stable or slightly improved during therapy, suggesting that Pepaxti does not adversely impact the kidneys at the studied doses. Validated dose optimization: The PK data directly validate the clinical use and efficacy of a 30 mg Pepaxti starting dose for patients with moderate renal impairment (eGFR =30 to <45 mL/min/1.73 m²). Sustained efficacy in fragile populations: Patients with moderate renal impairment achieved an Overall Response Rate (ORR) of 47.6% in Cohort 1a (40 mg starting dose) and 70.0% in Cohort 1b (30 mg starting dose), with a median progression-free survival (PFS) of 8.6 months and 7.7 months, respectively. No new safety signals: Despite advanced renal impairment and high treatment exposure, the safety profile was well-characterized and manageable. The most frequently reported treatment-emergent adverse events were hematological (thrombocytopenia, anemia, and neutropenia), which is consistent with previous clinical trials. The full article, titled "BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function," is available online via Clinical Lymphoma, Myeloma and Leukemia. Pepaxti (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.Breakeven Date Change • May 20Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.お知らせ • Mar 18Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 129,283,736 Price\Range: SEK 1.55 Transaction Features: Rights Offeringお知らせ • Feb 19+ 4 more updatesOncopeptides AB (publ) to Report Q2, 2026 Results on Aug 27, 2026Oncopeptides AB (publ) announced that they will report Q2, 2026 results on Aug 27, 2026お知らせ • Jan 17Oncopeptides AB (Publ) Provides Sales Guidance for the Fourth Quarter and Full Year 2025Oncopeptides AB (publ) provided sales guidance for the fourth quarter and full year 2025. For the quarter company expects net sales for the second quarter to amount to SEK 18.6 million an increase of 88% versus Fourth Quarter 2024. For the full year, the company expects net sales to amount to 71.2 million SEK, an increase of 125% versus 2024.お知らせ • Jan 16Oncopeptides AB (publ) to Report Fiscal Year 2025 Results on Feb 19, 2026Oncopeptides AB (publ) announced that they will report fiscal year 2025 results on Feb 19, 2026お知らせ • Sep 01Oncopeptides AB (publ) Announces the Publication of Two Real-World Evidence (RWE) Abstracts on Pepaxti At the International Myeloma Society Annual MeetingOncopeptides AB (publ) announced the publication of two real-world evidence (RWE) abstracts on Pepaxti at the International Myeloma Society (IMS) Annual Meeting, September 17-20 in Toronto, Canada. As previously communicated, the data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The Italian study reports an overall response rate (ORR) of 47% in a heavily pretreated patient population with relapsed or refractory multiple myeloma, confirming the efficacy previously demonstrated in the HORIZON trial with a similar safety profile. Importantly, the study demonstrated efficacy in patients treated with novel immunotherapies, underscoring the robust effectiveness of Pepaxti in daily clinical practice. The Spanish study confirms the efficacy of Pepaxti in an even more heavily pretreated patient population where the majority of patients had been exposed to either anti-BCMA or anti-GPRC5D immunotherapy, generating data highly relevant to clinicians seeking guidance for treatment decisions. Both studies confirm Pepaxti's favorable tolerability profile in real-world settings - a key consideration in multiple myeloma where safety challenges are common.お知らせ • Aug 22Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million.Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 46,947,534 Price\Range: SEK 3.2 Transaction Features: Rights Offeringお知らせ • Jul 23Oncopeptides AB (publ) Announces Acceptance of Spanish and Italian Real-World Data at IMS Annual MeetingOncopeptides AB (publ) announced that two real-world evidence (RWE) posters have been accepted for presentation at the upcoming International Myeloma Society (IMS) Annual Meeting, taking place in Toronto, Canada on September 17-20. The data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The accepted posters focus on real-world outcomes in heavily pretreated patients with relapsed or refractory multiple myeloma. While specific results will be shared at the congress, the inclusion of these patient cases reflects the increasing importance of RWE to guide treatment decisions in clinical practice. For a medicine with limited awareness and use to date, real-world data play a key role in building physician confidence and informing market access. The inclusion of these two posters at IMS follows a growing body of independent research that reflects clinical experiences across Europe.お知らせ • Jul 10+ 1 more updateOncopeptides AB (Publ) Announces Inclusion of Drug Pepaxti in New Clinical Practice Guidelines from Eha-EmnOncopeptides AB (publ) announced that its drug Pepaxti has been included in new clinical practice guidelines from EHA-EMN for patients with relapsed, refractory multiple myeloma. This marks an important recognition by leading experts of the drug's clinical value and ability to meet an unmet medical need in the treatment of this serious blood cancer. The guidelines are based on a thorough evaluation of clinical evidence by leading experts and aim to support doctors in selecting appropriate therapies for their patients. For patients who have received multiple prior lines of therapy and are triple-class refractory /exposed (TCR/TCE) - meaning their disease no longer responds to three major classes of myeloma drugs - Pepaxti is recommended based on Level 1 evidence, the strongest possible, and has a Grade B recommendation. Furthermore, Pepaxti has also been listed as a treatment option for patients with even more advanced disease, TCR/TCE patients relapsing after immunotherapy with either CART cells or ADC and whose disease no longer responds to four drug classes.お知らせ • May 22Oncopeptides AB (publ) Approves Election of Christine Rankin as Board MemberThe Annual General Meeting in Oncopeptides AB (publ) was held on 22 May 2025, approved election of Christine Rankin as board members.お知らせ • May 15+ 1 more updateOncopeptides AB (publ) to Report Q3, 2025 Results on Nov 05, 2025Oncopeptides AB (publ) announced that they will report Q3, 2025 results on Nov 05, 2025お知らせ • May 06Oncopeptides AB's Ordinary Shares to be Deleted from OTC EquityOncopeptides AB (publ) Ordinary Shares will be deleted from OTC Equity effective May 06, 2025, due to inactive security.お知らせ • Apr 17Oncopeptides AB (publ), Annual General Meeting, May 22, 2025Oncopeptides AB (publ), Annual General Meeting, May 22, 2025, at 10:00 W. Europe Standard Time. Location: at tandstickspalatset, vastra tradgardsgatan 15, stockholm Swedenお知らせ • Apr 16Oncopeptides AB (publ) Announces the Publication of New Real-World Data That Further Support the Effectiveness and Tolerability of Melflufen, Refractory Multiple MyelomaOncopeptides AB (publ) announced the publication of new real-world data that further support the effectiveness and tolerability of melflufen, branded in Europe as Pepaxti, in patients with relapsed, refractory multiple myeloma (RRMM). The data were presented in an abstract from the University of Catania, Italy. It highlights treatment outcomes in a single-center real-world setting. The retrospective analysis included eight triple-class refractory RRMM patients who had received a median of 3.5 prior lines of therapy. Notably, several patients presented with high-risk features, including extramedullary disease. Despite this, treatment with Pepaxti in combination with dexamethasone showed an overall response rate (ORR) of 37.5%, with partial responses seen even among patients with advanced disease manifestations. The data underline Pepaxti's role as a viable treatment option for patients with advanced RRMM for patients who have received at least three prior lines of therapy and whose disease has progressed on or after the last therapy.お知らせ • Mar 03Oncopeptides AB (publ) to Report Q1, 2025 Results on May 15, 2025Oncopeptides AB (publ) announced that they will report Q1, 2025 results on May 15, 2025お知らせ • Feb 20Oncopeptides AB (publ) to Report Q4, 2024 Results on Feb 27, 2025Oncopeptides AB (publ) announced that they will report Q4, 2024 results at 8:00 AM, Central European Standard Time on Feb 27, 2025お知らせ • Feb 06Jarl Ulf Jungnelius Resigns from Oncopeptides AB (publ) Board of DirectorsOncopeptides AB (publ) announced that Jarl Ulf Jungnelius has informed the Board of Directors of his decision to step down from the Bord of Directors of Oncopeptides in which he has served since 2011. This due to personal reasons related to a change of domicile from Sweden.お知らせ • Jan 27Oncopeptides' Pepaxti Formally Approves for Full Reimbursement in ItalyOncopeptides AB (publ) announced that the positive reimbursement decision for its drug Pepaxti (melflufen) has been published in the Italian Official Journal ("IOJ", It.: Gazetta Ufficiale). This marks the final regulatory step for the drug's upcoming commercialization in Italy, confirming Oncopeptides' expectation of first sales during first half, 2025. With the IOJ publication, Oncopeptides can now initiate the regional access process to bring Pepaxti to patients. The company's goal is to make the treatment available to eligible Italian patients with relapsed and refractory multiple myeloma over the coming months. Italy reports an annual incidence of approximately 6,000 new cases of multiple myeloma, and with about 1,800 patients falling within Pepaxti's target population. 79 patients across 10 Italian hospitals during the clinical development of Pepaxti and 86 treated patients in the Early Access Program (EAP) underscores the clinical experience in the country and high unmet need for the drug. The Early Access program have been closed following the reimbursement. As previously communicated, Oncopeptides is currently in the process of strengthening its presence in Italy by expanding its team and investing in initiatives to raise awareness about Pepaxti and its benefits.お知らせ • Jul 04An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million.An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million on July 2, 2024. Industrifonden Foundation has divested its entire stake in Oncopeptides. An undisclosed buyer completed the acquisition of 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden on July 2, 2024.お知らせ • May 17Oncopeptides AB (publ) Presents New Data Highlighting Treatment Benefits of Pepaxti in High-Risk Multiple Myeloma Patients at the COMy CongressOncopeptides AB (publ) announced that new scientific data on melflufen, branded in Europe as Pepaxti, has been accepted at the 10th annual World Congress on Cont Cont Cont Controversies in Multiple Myeloma (COMy), to be held on May 23-26. The study, published by a team from institutions across Europe, including the University of Wurzburg and the Institute for Molecular Medicine Finland, focuses on the effectiveness of melflufen and shows promising results for the drug when treating patients with a particularly challenging form of multiple myeloma. The study will be presented to congress attendees through an online oral presentation on May 26. The presentation will be given by Caroline Heckman, from the Institute for Molecular Medicine Finland. Multiple myeloma can be especially difficult to treat in patients who have specific genetic mutations or deletions, such as del(17p) and/or mutations in the TP53 gene. These genetic characteristics are associated with a poorer prognosis and shorter survival rates. The research findings indicate that melflufen is more effective than traditional alkylating agents causing DNA damage and promoting the death of cancer cells lacking a functional so-called p53 protein, which is a common issue in high-risk multiple myeloma cases. The study also highlighted significant changes in gene expression that enhance the drug's impact on cancer cells. Furthermore, patients with the del(17p) genetic abnormality treated with melflufen and dexamethasone showed a longer progression-free survival and higher overall response rate compared to those treated with pomalidomide and dexamethasone in the OP-103 OCEAN trial.お知らせ • Apr 05Oncopeptides AB (Publ) Provides Sales Guidance for the First Quarter of 2024Oncopeptides AB (publ) provided sales guidance for the first quarter of 2024. The company expected net sales to amount to SEK 5.1 million (SEK 1.1 million).お知らせ • Mar 13Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million.Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: Rights Offeringお知らせ • Feb 24Oncopeptides AB (publ), Annual General Meeting, May 22, 2024Oncopeptides AB (publ), Annual General Meeting, May 22, 2024.お知らせ • Dec 16Oncopeptides Announces European Commission Decides to Formally Approve its Application to EMA for Extended Indication for Pepaxti into Earlier LinesOncopeptides announced that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains. Oncopeptides has submitted an application to adjust the indication of Pepaxti to the originally approved indication, a process that is expected to be finalized in early 2024. During this time, Oncopeptides will work together with the European Commission, EMA as well as local stakeholders to ensure an efficient removal process for the extended indication.お知らせ • Nov 18Oncopeptides AB (publ) to Report Q3, 2024 Results on Nov 07, 2024Oncopeptides AB (publ) announced that they will report Q3, 2024 results on Nov 07, 2024お知らせ • Nov 15Oncopeptides Selects to Present Additional Data from Ocean StudyOncopeptides AB (publ) announced that long-term outcomes from its Phase 3 OCEAN study has been accepted as a poster and will be presented at the 65th annual American Society of Hematology (ASH) Meeting and Exposition. The conference takes place in San Diego between December 9-12. ASH is the world's professional hematologic society serving both clinicians and scientists around the world who are working to conquer blood diseases. The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.お知らせ • Oct 27Oncopeptides AB (publ) to Report Q2, 2024 Results on Aug 14, 2024Oncopeptides AB (publ) announced that they will report Q2, 2024 results at 8:00 AM, Central European Standard Time on Aug 14, 2024お知らせ • Oct 21Oncopeptides AB (publ) Announces the Nomination CommitteeOncopeptides AB (publ) announces that the composition of the Nomination Committee has been established. According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2024 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of the end of the third quarter 2023 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors. The Nomination Committee in respect of the annual general meeting 2024 consists of the following persons who together represent approximately 29 percent of the number of shares and votes in the company based on the shareholder information at end of September 2023. Staffan Lindstrand, appointed by HealthCap VI L.P., Patrik Sobocki, appointed by Stiftelsen Industrifonden, Caroline Mebius, appointed by Handelsbanken funds, and Per Wold-Olsen, the Chairman of the Board.お知らせ • Oct 12Oncopeptides AB (publ) to Report Q1, 2024 Results on May 03, 2024Oncopeptides AB (publ) announced that they will report Q1, 2024 results on May 03, 2024お知らせ • Oct 02Oncopeptides AB (publ) to Report Fiscal Year 2023 Final Results on Apr 22, 2024Oncopeptides AB (publ) announced that they will report fiscal year 2023 final results on Apr 22, 2024お知らせ • Sep 21Oncopeptides AB (publ) to Report Fiscal Year 2023 Results on Feb 27, 2024Oncopeptides AB (publ) announced that they will report fiscal year 2023 results on Feb 27, 2024お知らせ • Sep 15Oncopeptides AB (Publ) Announces Positive Opinion on Type II Variation to Extend the Therapeutic Indication of Pepaxti Based on Ocean Trial ResultsOncopeptides AB (publ) announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has, following their scientific assessment, adopted a positive opinion on Oncopeptides' application for earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM). The opinion from the CHMP will now be sent to the European Commission for a final decision. Based on findings from its OCEAN trial, Oncopeptides submitted, on 28 Nov. 2022, an application to extend the therapeutic indication of Pepaxti to the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy. With their opinion, CHMP recommends that the use of Pepaxti could be expanded to earlier lines of treatment and also peripheral administration, meaning delivery of treatment through peripheral rather than central veins, a less invasive way of administration. Oncopeptides will as a next step assess the current market dynamics of the rapidly evolving multiple myeloma landscape, including the competition in different lines of treatment and the effect that extending Pepaxti into earlier lines of treatment would have on Oncopeptides's ability to receive a reimbursed price that reflects its innovation.お知らせ • Aug 10Oncopeptides AB (publ) Appoints Henrik Bergentoft as Chief Financial OfficerOncopeptides AB (publ) announced that the company has appointed Henrik Bergentoft as Chief Financial Officer, CFO. Henrik was most recently CFO at RaySearch Laboratories and brings 20+ years of experience from leading finance roles at both medical and non-medical, publicly listed organizations. He will assume his new position during the fourth quarter, replacing Holger Lembrér.お知らせ • Aug 08+ 1 more updateOncopeptides AB (publ) Announces Sofia Heigis to Move from the CCO Role to CEO RoleOncopeptides AB (publ) announced that Sofia Heigis who will move from the CCO role to take on the CEO role.お知らせ • Jun 14Holger Lembrér Will Leave Oncopeptides as Chief Financial OfficerOncopeptides AB (publ) announced that Holger Lembrér, Chief Financial Officer (CFO) has decided to leave Oncopeptides to pursue a new role in another company. Holger was appointed CFO in January 2023. He will continue in his current role until December or until a new CFO takes office. A recruitment process will be initiated immediately.Board Change • Mar 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Mar 09Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Feb 18+ 2 more updatesOncopeptides AB (publ) to Report Q2, 2023 Results on Aug 10, 2023Oncopeptides AB (publ) announced that they will report Q2, 2023 results on Aug 10, 2023お知らせ • Jan 12Oncopeptides AB (Publ) Announces Chief Financial Officer ChangesOncopeptides AB (publ.) announced that the company has appointed Holger Lembrer as Chief Financial Officer, CFO. Prior to joining the company, Holger Lembrer was Business Unit CFO at Assa Abloy, and before that Investor Relations Officer, and Financial Controller. He has also been a Senior Auditor at Ernst & Young. Holger Lembrer will assume his new position before the end of February 2023 and will replace Annika Muskantor who has been interim CFO since November 1, 2021.お知らせ • Jan 05Oncopeptides AB (publ) Announces Jakob Lindberg Assumes Chief Scientific OfficerOncopeptides AB (publ) announced that the Board of Directors has appointed Dr. Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer.お知らせ • Jan 04Oncopeptides AB (Publ) Announces Executive ChangesOncopeptides AB (publ.) announced that the board of directors has appointed Dr. Monica Shaw as chief executive officer of the company. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer. These changes are effective immediately. Dr. Monica Shaw brings a wealth of executive leadership skills from the pharmaceutical industry, e.g., GSK and LEO Pharma, and has a strong track record from bringing more than 15 products through phase III to successful commercialization, globally and across many geographies. She has a broad therapeutic area knowledge from previous positions as a physician and within industry, including Immunology, Oncology, Virology, Neurology and Rare Diseases.お知らせ • Dec 15Oncopeptides AB (publ) to Report Fiscal Year 2022 Final Results on Apr 25, 2023Oncopeptides AB (publ) announced that they will report fiscal year 2022 final results at 9:00 AM, Central European Standard Time on Apr 25, 2023Board Change • Nov 29Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Oct 26Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Oct 12Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Sep 21Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Breakeven Date Change • Aug 13Forecast to breakeven in 2024The 2 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 68% per year to 2023. The company is expected to make a profit of kr200.2m in 2024. Average annual earnings growth of 30% is required to achieve expected profit on schedule.Board Change • Aug 09Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • May 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Mar 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Mar 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Feb 18Oncopeptides AB (publ) to Report Fiscal Year 2022 Results on Feb 16, 2023Oncopeptides AB (publ) announced that they will report fiscal year 2022 results at 8:00 AM, Central European Standard Time on Feb 16, 2023お知らせ • Sep 12Oncopeptides AB (Publ) Presents Phase 3 Ocean Study Results At the IMW MeetingOncopeptides AB presents data from the phase 3 OCEAN study, a direct head to head comparison of the efficacy and safety of melflufen plus dexamethasone and pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma, (RRMM), who are refractory to lenalidomide and have received 2-4 prior lines of therapy. The data was presented by Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway, at the 18 International Myeloma Workshop in Vienna. Melflufen met the primary endpoint of superior Progression Free Survival as assessed by the Independent Review Committee (IRC), with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide, a Hazard Ratio (HR) of 0.79, and a p-value of 0.03. The results of key secondary endpoints in the Intention to Treatpopulation were Overall Survival (OS), which favored pomalidomide with a HR of 1.10, and Overall Response Rate, where melflufen had a numerically higher ORR of 33 % compared to 27% for pomalidomide.お知らせ • Aug 28Oncopeptides AB (publ) Presents New Data from OCEAN and PORT Study - Abstracts OnlineOncopeptides AB (publ) announced that data from the phase 3 OCEAN study has been accepted as an oral presentation at the upcoming 18thInternational Myeloma Workshop (IMW), and the abstract is now available online. More comprehensive data will be presented at the IMW-meeting in Vienna on September 11, at 10:00 (CET). The phase 3 OCEAN study is a head-to-head comparison evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone. Melflufen met its primary endpoint and demonstrated superior Progression Free Survival (PFS) as assessed by the Independent Review Committee (IRC) versus pomalidomide, in patients with relapsed refractory multiple myeloma (RRMM) who are refractory to lenalidomide and have received 2-4 prior lines of therapy, with a Hazard Ratio* (HR) of 0.79, and p-value of 0.03. Overall Survival (OS) was a key secondary endpoint. The HR for OS was 1.10 in favor of pomalidomide in the Intention to Treat (ITT) population. At the IMW Oncopeptides will also present data from the phase 2 PORT study, an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with RRMM.Recent Insider Transactions • Aug 25Deputy CEO & CFO recently bought kr82k worth of stockOn the 23rd of August, Anders Martin-Löf bought around 2k shares on-market at roughly kr41.18 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr200k. Anders has been a buyer over the last 12 months, purchasing a net total of kr220k worth in shares.Breakeven Date Change • Jul 30No longer forecast to breakevenThe 5 analysts covering Oncopeptides no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr8.80m in 2023. New consensus forecast suggests the company will make a loss of kr267.4m in 2023.お知らせ • Jul 15Oncopeptides' Pepaxto Receives Specific C-Code and Pass-Through Payment Status Further Streamlining Reimbursement in Hospital Sites of CareOncopeptides AB (publ) announced that the Centers for Medicare and Medicaid Services (CMS) have established a specific C-Code for PEPAXTO®, C9080. The code went into effect on July 1, 2021, and will be active through June of 2024. C-codes are specific temporary pricing codes established for the Prospective Payment System, exclusively for the Hospital Outpatient setting of care. The c-code, and the transitional pass-through status that it confers, is intended to encourage the use of newly FDA-approved drugs to increase Medicare patients' access to new and innovative therapies by temporarily paying more than established facility fees. Oncopeptides' anticipates a permanent J-Code will be assigned in the third quarter of 2021. PEPAXTO in combination with dexamethasone was approved by the FDA under accelerated approval on February 26, 2021, based upon the HORIZON study for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.Breakeven Date Change • Jul 09Forecast to breakeven in 2023The 5 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 32% per year to 2022. The company is expected to make a profit of kr8.80m in 2023. Average annual earnings growth of 67% is required to achieve expected profit on schedule.Recent Insider Transactions • Jun 03Insider recently bought kr200k worth of stockOn the 28th of May, Fredrik Lehmann bought around 2k shares on-market at roughly kr100.00 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr501k. Despite this recent purchase, insiders have collectively sold kr16m more in shares than they bought in the last 12 months.お知らせ • May 25+ 1 more updateOncopeptides AB Announces Positive Topline Results from the Head-To-Head Phase 3 Ocean Study Evaluating the Efficacy and Safety of MelflufenOncopeptides AB announced positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results will be presented at a webcast on May 25, 2021, at 11:00 (CET). The PFS, as assessed by the independent review committee, demonstrated a Hazard Ratio favoring melflufen of 0.817 (95% CI: 0.659-1.012, p=0.0640) for the primary endpoint and shows that melflufen is non-inferior to pomalidomide. The Hazard Ratio for PFS as per investigator assessment was 0.790 (95% CI: 0.639-0.976). In both assessments, the median PFS for the melflufen arm was more than 40% higher than for the pomalidomide arm. The Overall Response Rate for melflufen was 32.1% vs. 26.5% for pomalidomide. Pepaxto® (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.Breakeven Date Change • May 21Forecast breakeven pushed back to 2024The 5 analysts covering Oncopeptides previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of kr555.0m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule.お知らせ • May 21Oncopeptides AB (Publ) Presents Clinical Abstracts on Melflufen At the 2021 American Society of Clinical OncologyOncopeptides AB (publ) announced that three abstracts with data on melflufen (INN melphalan flufenamide) in relapsed refractory multiple myeloma, RRMM, have been accepted by the 2021 American Society of Clinical Oncology, ASCO, and have now been published online. The clinical data presentations include updates on Oncopeptides' ANCHOR and LIGHTHOUSE studies as well as a pooled analysis of the O-12-M1 and HORIZON studies in patients who have been exposed to or become refractory to prior alkylators. Anchor (Op-104): Melflufen Plus Dexamethasone and Bortezomib in Relapsed/Refractory Multiple Myeloma Patients: The ANCHOR study determined that the optimal dose of melflufen is 30 mg plus dexamethasone and bortezomib and the results showed clinical activity in heavily pretreated RRMM patients. Recruitment for this study is ongoing and updated data including efficacy and safety will be presented at ASCO. Lighthouse (Op-108): A Phase 3 Study of Melflufen in Combination with Dexamethasone and Daratumumab in Relapsed/Refractory Multiple Myeloma Patients: A Pooled Analysis of the O-12-M1 and Horizon Studies: Melflufen Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients (Rrmm) Who Are Exposed or Refractory to Prior Alkylators The phase 3 LIGHTHOUSE study is a randomized, controlled, open-label study of melflufen plus dexamethasone in combination with daratumumab vs daratumumab alone in patients with RRMM previously treated with an immunomodulatory agent and a proteasome inhibitor, similar to the indication for daratumumab monotherapy. The primary objective is superiority of PFS. Key secondary endpoints include ORR (= PR), DOR, and safety. Patient recruitment is ongoing with a planned enrolment of 240 patients.お知らせ • May 13Oncopeptides AB (publ) Presents New Clinical and Preclinical Melflufen Data at the Upcoming European Hematology Association MeetingOncopeptides AB (publ) announced that new clinical and preclinical data have been accepted by the European Hematology Association, EHA, and been published online. The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function. Two preclinical data presentations show the future potential of melflufen in treatments of other hematological diseases outside multiple myeloma. In addition, the last preclinical data presentation provides an increased understanding of melflufen 's mode of action. Below is a brief description of the abstracts that have been accepted by the EHA. They will be available online at ehaweb.org, from May 12th at 16:00 (CET). 1. BRIDGE (OP-107): A PHASE 2 PHARMACOKINETIC STUDY OF MELFLUFEN PLUS DEXAMETHASONE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA AND IMPAIRED RENAL FUNCTION: The study demonstrates that for patients receiving melflufen in the phase 2 BRIDGE study, the exposure to melphalan increased with reduced eGFR (Estimated Glomerular Filtration Rate), similar to what is observed during treatment with melphalan. The overall toxicity profile was as expected for melflufen and dexamethasone and no new safety signals were observed, supporting the use of melflufen in patients with moderate renal impairment. 2. MELFLUFEN DEMONSTRATES HIGH EFFICACY IN CYTARABINE AND VENETOCLAX RESISTANT AML MODELS: The study shows that multiple aminopeptidases are highly expressed in AML-samples, providing a good rationale for using melflufen therapy. Patients with Acute Myeloid Leukemia, often develop resistance to current treatments, including cytarabine and venetoclax, yet in pre-clinical models of resistance to these agents, melflufen shows high efficacy. 3. MELPHALAN FLUFENAMIDE IS A HIGHLY POTENT ANTI-NEOPLASTIC AGENT IN HIGH RISK DLBCL MODELS: Several aminopeptidase genes are highly expressed in samples of patients with DLBCL, Diffuse Large B-Cell Lymphoma, and their elevated expression is associated with significantly shorter survival. In preclinical in vitro tests of DLBCL cell lines, melflufen shows superior cytotoxicity compared to Standard of Care drugs doxorubicin and bendamustine. 4. MELFLUFEN RAPIDLY ACCUMULATES WITHIN TUMOR CELLS AND DISTRIBUTES AN ALKYLATING PAYLOAD TO THE NUCLEUS AND MITOCHONDRIA: The increased lipophilicity of melflufen can affect the redistribution of the alkylating payload within the cell. Data show that melflufen, but not melphalan, localized significantly within lysosomes, endoplasmic reticulum and importantly mitochondria, which may affect the mechanism of cancer cell killing. PEPAXTO. (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.お知らせ • May 06Oncopeptides AB Completes Patient Enrollment in Phase 2 Port StudyOncopeptides AB announced that the Company has completed patient enrollment in the phase 2 PORT study. The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma. Oncopeptides expects topline data in third quarter of 2021.Recent Insider Transactions • Mar 18Chief Scientific Officer recently sold kr16m worth of stockOn the 10th of March, Jakob Lindberg sold around 100k shares on-market at roughly kr158 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr17m more than they bought in the last 12 months.お知らせ • Mar 16Oncopeptides Announces Commercial Availability of PEPAXTO®Oncopeptides AB (publ) announced that PEPAXTO® (melphalan flufenamide) is now commercially available and that the first patients are being treated with the drug. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The company is committed to working with payers and healthcare providers across the United States to help ensure that all patients prescribed PEPAXTO have access to it. The company has established a Patient Assistance Program called ON COURSE for people who may not have access to health insurance or have an insurance plan that does not cover the entire cost of the medication. Some restrictions apply and patients need to meet certain eligibility criteria. Additionally, the ON COURSE team offers benefits verification, prior authorization assistance, claims management and appeals. The ON COURSE team is comprised of nurse case managers that offer personalized attention through the treatment process including helping patients and caregivers connect to support groups and organizations in the multiple myeloma community.お知らせ • Mar 12Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 1.1218 billion.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 1.1218 billion. Security Name: Shares Security Type: Common Stock Securities Offered: 7,100,000 Price\Range: SEK 158 Transaction Features: Subsequent Direct Listingお知らせ • Mar 09Oncopeptides AB (Publ) Announces Executive ChangesOncopeptides AB (publ) announced that it strengthens the leadership of the European operations by appointing Andrea Passalacqua as General Manager in Europe, and Pamela Bacon as Head of Medical Affairs Europe. As previously announced, Oncopeptides will also seek a Conditional Marketing Authorization of melphalan flufenamide in triple class refractory multiple myeloma, during second quarter of 2021. In his capacity as General Manager in Europe, Andrea Passalacqua will be part of the global Leadership Team of Oncopeptides AB. Andreas brings extensive commercial experience from Amgen and Celgene in multiple myeloma, and most recently he served as General Manager in Italy for Bluebird Bio. Pamela Bacon carries a significant proficiency in the multiple myeloma space and has an in-depth experience from several global Medical Affairs roles within Celgene and Amgen.お知らせ • Feb 27Oncopeptides AB (publ) Receives U.S. Food and Drug Administration Approval for PEPAXTO for Patients with Relapsed or Refractory Multiple MyelomaOncopeptides AB (publ) announced that the U.S. Food and Drug Administration, FDA, has approved PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The company will begin promoting PEPAXTO to healthcare professionals across the U.S. immediately and expects a labeled product in distribution centers and specialty pharmacies within approximately two weeks. PEPAXTO is the first anticancer peptide-drug conjugate approved by the FDA. The product has been granted accelerated approval based on the phase 2 HORIZON study in relapsed or refractory multiple myeloma. The HORIZON study evaluating intravenous melflufen in combination with dexamethasone, included heavily pre-treated patients with a poor prognosis. This multi-center single arm study evaluated 157 patients with relapsed or refractory multiple myeloma, of whom 97 were triple-class refractory and had received at least four prior lines of treatment. The Overall Response Rate for the patients within this group of patients with refractory multiple myeloma was 23.7% and the Median Duration of Response was 4.2 months. Furthermore, melflufen in combination with dexamethasone demonstrated activity in a subset of patients with Extra Medullary Disease (41%), an aggressive and resistant disease associated with a poor prognosis.Is New 90 Day High Low • Feb 26New 90-day high: kr180The company is up 18% from its price of kr152 on 27 November 2020. The British market is up 6.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 27% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is kr3.52 per share.お知らせ • Feb 13+ 1 more updateOncopeptides AB (publ) to Report Q2, 2021 Results on Aug 26, 2021Oncopeptides AB (publ) announced that they will report Q2, 2021 results on Aug 26, 2021Recent Insider Transactions • Jan 20Insider recently sold kr772k worth of stockOn the 15th of January, Fredrik Lehmann sold around 5k shares on-market at roughly kr166 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.お知らせ • Dec 23Oncopeptides Enrolls the First Patient in the Phase 3 LIGHTHOUSE Combination Study in Multiple MyelomaOncopeptides AB (publ) announced that the first patient has been dosed in the phase 3 LIGHTHOUSE study, evaluating the efficacy and safety of a triple combination therapy with melflufen plus dexamethasone and subcutaneous daratumumab compared to daratumumab alone. The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.お知らせ • Dec 17Oncopeptides AB Appoints Linda Holmström as Director of Investor RelationsOncopeptides AB announced that Linda Holmström has been appointed Director of Investor Relations. Linda has more than 15 years of experience from the life science industry. Prior to joining Oncopeptides she held the position as Senior Corporate Communications and Investor Relations Manager at Sobi, Swedish Orphan Biovitrum AB (publ). Linda assumes the responsibility for Investor Relations. Rein Piir who has been responsible for the Investor Relations function during the last four years will continue to work as a senior advisor.お知らせ • Dec 11+ 1 more updateOncopeptides AB (Publ) Announces That the Pivotal Phase 2 HORIZON Study Evaluating Intravenous Melflufen (INN Melphalan Flufenamide) in Combination with Dexamethasone in Relapsed Refractory Multiple Myeloma, Has Been Published in the Peer-Reviewed Journal of Clinical OncologyOncopeptides AB (publ) announced that the pivotal phase 2 HORIZON study evaluating intravenous melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma, has been published in the peer-reviewed Journal of Clinical Oncology. The phase 2 HORIZON data are the basis for the ongoing priority review of the New Drug Application to the US Food and Drug Administration FDA, for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma patients, who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody. The phase 2 HORIZON study is a pivotal, single-arm, multicenter, phase 2 study evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma. The study included 157 heavily pretreated patients, who had received >2 earlier lines of therapy with immunomodulatory drugs and proteasome inhibitors and were refractory to pomalidomide and/or daratumumab. The HORIZON study population includes subgroups of patients who were triple-class refractory and/or had extramedullary disease and/or had cytogenetic high-risk features.お知らせ • Nov 20+ 1 more updateOncopeptides AB (publ) to Report Q1, 2021 Results on May 26, 2021Oncopeptides AB (publ) announced that they will report Q1, 2021 results on May 26, 2021お知らせ • Nov 06Oncopeptides AB (publ) Announces New Data for Melflufen Accepted for Presentation at the Annual American Society of Hematology MeetingOncopeptides AB (publ) announced that twelve abstracts, including one oral presentation, have been accepted for the upcoming virtual American Society of Hematology (ASH) meeting on December 5-8, 2020. Key clinical abstracts focus on data from the ongoing phase 1/2 ANCHOR combination study and the pivotal phase 2 HORIZON study. The preclinical abstracts further explore the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma. The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma and sets the foundation for the planned phase 3 LIGHTHOUSE daratumumab combination study. Seven clinical abstracts are based on the HORIZON study, most notable are the subgroup analysis of patients exposed to and refractory to alkylators and the analysis of patients with extramedullary disease, that further verify the distinct mechanism of action of melflufen. Melflufen (INN Melphalan flufenamide) is an investigational first-in-class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is in late-stage clinical development for the treatment of patients with triple-class refractory multiple myeloma and has recently been granted a priority review by the U.S. Food and Drug Administration, FDA, for a New Drug Application based on the results from the phase 2 HORIZON study.お知らせ • Oct 19Oncopeptides AB (publ) Submits Investigational New Drug application to FDA for the second drug candidate from the PDC platformOncopeptides AB (publ) announced that the company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC). Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma. The specific formulation enables administration of high doses which provides a clear rationale for treatment of this patient group. OPD5 is based on the proprietary PDC platform. Peptide-drug conjugates leverages aminopeptidases and releases alkylating agents rapidly into tumor cells. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden.お知らせ • Oct 13Oncopeptides AB (publ) Intents to File for Conditional Approval of Melflufen with EMAOncopeptides AB (publ) announced that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM). The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await the results from the ongoing randomized, phase 3 OCEAN study before submitting an application for marketing authorization. Upon completion, the outcome from the OCEAN study comparing melflufen and pomalidomide in patients with RRMM, will be submitted to regulatory authorities to potentially expand the label of melflufen. The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD). According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if; the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data. The US Food and Drug Administration, FDA, has granted priority review to Oncopeptides' New Drug Application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA has set a target date for the review of the New Drug Application, to February 28, 2021.お知らせ • Oct 04Oncopeptides initiates U.S. Expanded Access Program with melflufen in triple-class refractory multiple myelomaOncopeptides AB (publ) announced that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The Expanded Access Program was initiated following the Company's June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma. The NDA and the sEAPort program are primarily supported by data from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma who are hard to treat and have a poor prognosis, including patients with triple-class refractory multiple myeloma and patients with extramedullary disease. EAPs are designed to provide patients living with serious or life-threatening conditions access to investigational medicines when no comparable or satisfactory treatment options are available, alternative therapies have been exhausted or the patient is ineligible for ongoing interventional trials. Forty to fifty medical sites in the U.S. are expected to enroll 100-200 patients in the sEAPort program.株主還元ONCOSGB BiotechsGB 市場7D0%-1.9%-1.3%1Y-64.6%-9.9%17.6%株主還元を見る業界別リターン: ONCOS過去 1 年間で-9.9 % の収益を上げたUK Biotechs業界を下回りました。リターン対市場: ONCOSは、過去 1 年間で17.6 % のリターンを上げたUK市場を下回りました。価格変動Is ONCOS's price volatile compared to industry and market?ONCOS volatilityONCOS Average Weekly Movementn/aBiotechs Industry Average Movement7.4%Market Average Movement5.0%10% most volatile stocks in GB Market10.3%10% least volatile stocks in GB Market2.6%安定した株価: ONCOSの株価は、 UK市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のONCOSのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト200077Sofia Heigiswww.oncopeptides.com/svOncopeptides AB（publish）はバイオテクノロジー企業で、米国、欧州、および国際的に、治療困難な血液疾患に対する標的療法の研究、開発、商業化に従事している。主要製品候補は、成人再発難治性多発性骨髄腫治療薬ペパキスチ（メルフルフェン）。同社のPDCプラットフォームは、ペプチドキャリアと細胞毒性ペイロードの2つのコンポーネントで設計されており、がん細胞の代謝の変化を利用してPDCを加水分解し、活性な親水性代謝産物に変換することで、がん細胞を濃縮する。OPD5、OPDC3、グリオペップを血液腫瘍、固形腫瘍、膠芽腫の治療に提供している。同社はまた、NK細胞と様々ながん細胞上の特異的標的の両方に結合するように設計されたSmall Polypeptide based Killer Engagers（SPiKE）プラットフォームも提供している。オンコペプチド社は2000年に設立され、スウェーデンのストックホルムに本社を置いている。もっと見るOncopeptides AB (publ) 基礎のまとめOncopeptides の収益と売上を時価総額と比較するとどうか。ONCOS 基礎統計学時価総額SEK 623.76m収益（TTM）-SEK 221.10m売上高(TTM)SEK 83.24m7.5xP/Sレシオ-2.8xPER（株価収益率ONCOS は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ONCOS 損益計算書（TTM）収益SEK 83.24m売上原価SEK 2.86m売上総利益SEK 80.38mその他の費用SEK 301.48m収益-SEK 221.10m直近の収益報告Mar 31, 2026次回決算日Aug 27, 2026一株当たり利益（EPS）-0.56グロス・マージン96.57%純利益率-265.63%有利子負債／自己資本比率170.3%ONCOS の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/08/15 23:19終値2026/06/08 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Oncopeptides AB (publ) 3 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。7 アナリスト機関Erik HultgårdCarnegie Investment Bank ABPatrik LingDNB CarnegieErik HultgårdDNB Carnegie4 その他のアナリストを表示
お知らせ • Jun 17Oncopeptides AB (Publ) Announces Enrollment of First Patient in Oncopeptides' Glioblastoma StudyOncopeptides AB (publ) announced that the first patient has been enrolled in the clinical "Window-of-Opportunity" (WoO) study evaluating its proprietary Peptide Drug Conjugate (PDC) platform in glioblastoma. The WoO study, named OP-701 (INSULA), represents the first clinical evaluation of a PDC in glioblastoma, marking a major strategic milestone as Oncopeptides expands its core technology platform beyond multiple myeloma. The focused trial will enroll approximately 10 patients to provide initial human proof-of-concept to assess that the company's technology successfully penetrates the human blood-brain barrier (BBB) in glioblastoma patients and have cytotoxic (cell killing) activity in tumor cells. The BBB remains the primary clinical obstacle and causes most traditional oncological drugs to fail in this disease. By utilizing an approved drug from Oncopeptides' platform as a "clinical probe," the study employs an innovative and highly efficient design to capture drug activity directly within the tumor tissue from patients scheduled for surgery for recurrent disease. This approach aims to validate the underlying biological mechanism in a rapid, cost-efficient manner before advancing a PDC asset into formal dose-finding and potential further clinical trials. Glioblastoma is the most aggressive and devastating form of brain cancer, characterized by rapid tumor growth, invariable relapse, and a total lack of curative options, with a median survival rate of just 12–15 months. The global glioblastoma market represents a profound unmet medical need and is estimated to be worth more than 8 billion USD by 2035. Oncopeptides' PDC molecules are believed to be uniquely equipped to pass the blood-brain barrier due to their small size and lipophilicity, entering the target cancer cells freely to deliver their cytotoxic payload directly where it is needed. The trial is conducted at Oslo University Hospital in Norway.
Breakeven Date Change • Jun 08Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.
お知らせ • May 22Oncopeptides AB Announces Publication of Phase 2 Bridge Study Results for Pepaxti in Relapsed Refractory Multiple Myeloma Patients with Renal ImpairmentOncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, announced the publication of the results from the Phase 2 BRIDGE (OP-107) clinical study in the peer-reviewed journal Clinical Lymphoma, Myeloma and Leukemia. The prospective, open-label study evaluated the pharmacokinetics (PK), safety, and efficacy of Pepaxti (melflufen) plus dexamethasone in relapsed, refractory multiple myeloma (RRMM) patients with moderate-to-severe renal impairment (RI). Patients with renal insufficiency represent roughly half of all myeloma diagnoses and typically suffer from poorer long-term outcomes and limited clinical options. The final analyses demonstrate that while systemic exposure to the active metabolite melphalan varies based on baseline kidney function, a reduced melflufen starting dose of 30 mg in patients with moderate renal impairment delivers a consistent safety profile, treatment responses, and survival measures aligned with prior trials conducted in less selected populations. Furthermore, exploratory data gathered across the treatment cycles showed that renal function remained stable or slightly improved during therapy, suggesting that Pepaxti does not adversely impact the kidneys at the studied doses. Validated dose optimization: The PK data directly validate the clinical use and efficacy of a 30 mg Pepaxti starting dose for patients with moderate renal impairment (eGFR =30 to <45 mL/min/1.73 m²). Sustained efficacy in fragile populations: Patients with moderate renal impairment achieved an Overall Response Rate (ORR) of 47.6% in Cohort 1a (40 mg starting dose) and 70.0% in Cohort 1b (30 mg starting dose), with a median progression-free survival (PFS) of 8.6 months and 7.7 months, respectively. No new safety signals: Despite advanced renal impairment and high treatment exposure, the safety profile was well-characterized and manageable. The most frequently reported treatment-emergent adverse events were hematological (thrombocytopenia, anemia, and neutropenia), which is consistent with previous clinical trials. The full article, titled "BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function," is available online via Clinical Lymphoma, Myeloma and Leukemia. Pepaxti (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
Breakeven Date Change • May 20Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.
お知らせ • Mar 18Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 129,283,736 Price\Range: SEK 1.55 Transaction Features: Rights Offering
お知らせ • Feb 19+ 4 more updatesOncopeptides AB (publ) to Report Q2, 2026 Results on Aug 27, 2026Oncopeptides AB (publ) announced that they will report Q2, 2026 results on Aug 27, 2026
お知らせ • Jun 17Oncopeptides AB (Publ) Announces Enrollment of First Patient in Oncopeptides' Glioblastoma StudyOncopeptides AB (publ) announced that the first patient has been enrolled in the clinical "Window-of-Opportunity" (WoO) study evaluating its proprietary Peptide Drug Conjugate (PDC) platform in glioblastoma. The WoO study, named OP-701 (INSULA), represents the first clinical evaluation of a PDC in glioblastoma, marking a major strategic milestone as Oncopeptides expands its core technology platform beyond multiple myeloma. The focused trial will enroll approximately 10 patients to provide initial human proof-of-concept to assess that the company's technology successfully penetrates the human blood-brain barrier (BBB) in glioblastoma patients and have cytotoxic (cell killing) activity in tumor cells. The BBB remains the primary clinical obstacle and causes most traditional oncological drugs to fail in this disease. By utilizing an approved drug from Oncopeptides' platform as a "clinical probe," the study employs an innovative and highly efficient design to capture drug activity directly within the tumor tissue from patients scheduled for surgery for recurrent disease. This approach aims to validate the underlying biological mechanism in a rapid, cost-efficient manner before advancing a PDC asset into formal dose-finding and potential further clinical trials. Glioblastoma is the most aggressive and devastating form of brain cancer, characterized by rapid tumor growth, invariable relapse, and a total lack of curative options, with a median survival rate of just 12–15 months. The global glioblastoma market represents a profound unmet medical need and is estimated to be worth more than 8 billion USD by 2035. Oncopeptides' PDC molecules are believed to be uniquely equipped to pass the blood-brain barrier due to their small size and lipophilicity, entering the target cancer cells freely to deliver their cytotoxic payload directly where it is needed. The trial is conducted at Oslo University Hospital in Norway.
Breakeven Date Change • Jun 08Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.
お知らせ • May 22Oncopeptides AB Announces Publication of Phase 2 Bridge Study Results for Pepaxti in Relapsed Refractory Multiple Myeloma Patients with Renal ImpairmentOncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, announced the publication of the results from the Phase 2 BRIDGE (OP-107) clinical study in the peer-reviewed journal Clinical Lymphoma, Myeloma and Leukemia. The prospective, open-label study evaluated the pharmacokinetics (PK), safety, and efficacy of Pepaxti (melflufen) plus dexamethasone in relapsed, refractory multiple myeloma (RRMM) patients with moderate-to-severe renal impairment (RI). Patients with renal insufficiency represent roughly half of all myeloma diagnoses and typically suffer from poorer long-term outcomes and limited clinical options. The final analyses demonstrate that while systemic exposure to the active metabolite melphalan varies based on baseline kidney function, a reduced melflufen starting dose of 30 mg in patients with moderate renal impairment delivers a consistent safety profile, treatment responses, and survival measures aligned with prior trials conducted in less selected populations. Furthermore, exploratory data gathered across the treatment cycles showed that renal function remained stable or slightly improved during therapy, suggesting that Pepaxti does not adversely impact the kidneys at the studied doses. Validated dose optimization: The PK data directly validate the clinical use and efficacy of a 30 mg Pepaxti starting dose for patients with moderate renal impairment (eGFR =30 to <45 mL/min/1.73 m²). Sustained efficacy in fragile populations: Patients with moderate renal impairment achieved an Overall Response Rate (ORR) of 47.6% in Cohort 1a (40 mg starting dose) and 70.0% in Cohort 1b (30 mg starting dose), with a median progression-free survival (PFS) of 8.6 months and 7.7 months, respectively. No new safety signals: Despite advanced renal impairment and high treatment exposure, the safety profile was well-characterized and manageable. The most frequently reported treatment-emergent adverse events were hematological (thrombocytopenia, anemia, and neutropenia), which is consistent with previous clinical trials. The full article, titled "BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function," is available online via Clinical Lymphoma, Myeloma and Leukemia. Pepaxti (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
Breakeven Date Change • May 20Forecast to breakeven in 2028The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule.
お知らせ • Mar 18Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 129,283,736 Price\Range: SEK 1.55 Transaction Features: Rights Offering
お知らせ • Feb 19+ 4 more updatesOncopeptides AB (publ) to Report Q2, 2026 Results on Aug 27, 2026Oncopeptides AB (publ) announced that they will report Q2, 2026 results on Aug 27, 2026
お知らせ • Jan 17Oncopeptides AB (Publ) Provides Sales Guidance for the Fourth Quarter and Full Year 2025Oncopeptides AB (publ) provided sales guidance for the fourth quarter and full year 2025. For the quarter company expects net sales for the second quarter to amount to SEK 18.6 million an increase of 88% versus Fourth Quarter 2024. For the full year, the company expects net sales to amount to 71.2 million SEK, an increase of 125% versus 2024.
お知らせ • Jan 16Oncopeptides AB (publ) to Report Fiscal Year 2025 Results on Feb 19, 2026Oncopeptides AB (publ) announced that they will report fiscal year 2025 results on Feb 19, 2026
お知らせ • Sep 01Oncopeptides AB (publ) Announces the Publication of Two Real-World Evidence (RWE) Abstracts on Pepaxti At the International Myeloma Society Annual MeetingOncopeptides AB (publ) announced the publication of two real-world evidence (RWE) abstracts on Pepaxti at the International Myeloma Society (IMS) Annual Meeting, September 17-20 in Toronto, Canada. As previously communicated, the data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The Italian study reports an overall response rate (ORR) of 47% in a heavily pretreated patient population with relapsed or refractory multiple myeloma, confirming the efficacy previously demonstrated in the HORIZON trial with a similar safety profile. Importantly, the study demonstrated efficacy in patients treated with novel immunotherapies, underscoring the robust effectiveness of Pepaxti in daily clinical practice. The Spanish study confirms the efficacy of Pepaxti in an even more heavily pretreated patient population where the majority of patients had been exposed to either anti-BCMA or anti-GPRC5D immunotherapy, generating data highly relevant to clinicians seeking guidance for treatment decisions. Both studies confirm Pepaxti's favorable tolerability profile in real-world settings - a key consideration in multiple myeloma where safety challenges are common.
お知らせ • Aug 22Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million.Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 46,947,534 Price\Range: SEK 3.2 Transaction Features: Rights Offering
お知らせ • Jul 23Oncopeptides AB (publ) Announces Acceptance of Spanish and Italian Real-World Data at IMS Annual MeetingOncopeptides AB (publ) announced that two real-world evidence (RWE) posters have been accepted for presentation at the upcoming International Myeloma Society (IMS) Annual Meeting, taking place in Toronto, Canada on September 17-20. The data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The accepted posters focus on real-world outcomes in heavily pretreated patients with relapsed or refractory multiple myeloma. While specific results will be shared at the congress, the inclusion of these patient cases reflects the increasing importance of RWE to guide treatment decisions in clinical practice. For a medicine with limited awareness and use to date, real-world data play a key role in building physician confidence and informing market access. The inclusion of these two posters at IMS follows a growing body of independent research that reflects clinical experiences across Europe.
お知らせ • Jul 10+ 1 more updateOncopeptides AB (Publ) Announces Inclusion of Drug Pepaxti in New Clinical Practice Guidelines from Eha-EmnOncopeptides AB (publ) announced that its drug Pepaxti has been included in new clinical practice guidelines from EHA-EMN for patients with relapsed, refractory multiple myeloma. This marks an important recognition by leading experts of the drug's clinical value and ability to meet an unmet medical need in the treatment of this serious blood cancer. The guidelines are based on a thorough evaluation of clinical evidence by leading experts and aim to support doctors in selecting appropriate therapies for their patients. For patients who have received multiple prior lines of therapy and are triple-class refractory /exposed (TCR/TCE) - meaning their disease no longer responds to three major classes of myeloma drugs - Pepaxti is recommended based on Level 1 evidence, the strongest possible, and has a Grade B recommendation. Furthermore, Pepaxti has also been listed as a treatment option for patients with even more advanced disease, TCR/TCE patients relapsing after immunotherapy with either CART cells or ADC and whose disease no longer responds to four drug classes.
お知らせ • May 22Oncopeptides AB (publ) Approves Election of Christine Rankin as Board MemberThe Annual General Meeting in Oncopeptides AB (publ) was held on 22 May 2025, approved election of Christine Rankin as board members.
お知らせ • May 15+ 1 more updateOncopeptides AB (publ) to Report Q3, 2025 Results on Nov 05, 2025Oncopeptides AB (publ) announced that they will report Q3, 2025 results on Nov 05, 2025
お知らせ • May 06Oncopeptides AB's Ordinary Shares to be Deleted from OTC EquityOncopeptides AB (publ) Ordinary Shares will be deleted from OTC Equity effective May 06, 2025, due to inactive security.
お知らせ • Apr 17Oncopeptides AB (publ), Annual General Meeting, May 22, 2025Oncopeptides AB (publ), Annual General Meeting, May 22, 2025, at 10:00 W. Europe Standard Time. Location: at tandstickspalatset, vastra tradgardsgatan 15, stockholm Sweden
お知らせ • Apr 16Oncopeptides AB (publ) Announces the Publication of New Real-World Data That Further Support the Effectiveness and Tolerability of Melflufen, Refractory Multiple MyelomaOncopeptides AB (publ) announced the publication of new real-world data that further support the effectiveness and tolerability of melflufen, branded in Europe as Pepaxti, in patients with relapsed, refractory multiple myeloma (RRMM). The data were presented in an abstract from the University of Catania, Italy. It highlights treatment outcomes in a single-center real-world setting. The retrospective analysis included eight triple-class refractory RRMM patients who had received a median of 3.5 prior lines of therapy. Notably, several patients presented with high-risk features, including extramedullary disease. Despite this, treatment with Pepaxti in combination with dexamethasone showed an overall response rate (ORR) of 37.5%, with partial responses seen even among patients with advanced disease manifestations. The data underline Pepaxti's role as a viable treatment option for patients with advanced RRMM for patients who have received at least three prior lines of therapy and whose disease has progressed on or after the last therapy.
お知らせ • Mar 03Oncopeptides AB (publ) to Report Q1, 2025 Results on May 15, 2025Oncopeptides AB (publ) announced that they will report Q1, 2025 results on May 15, 2025
お知らせ • Feb 20Oncopeptides AB (publ) to Report Q4, 2024 Results on Feb 27, 2025Oncopeptides AB (publ) announced that they will report Q4, 2024 results at 8:00 AM, Central European Standard Time on Feb 27, 2025
お知らせ • Feb 06Jarl Ulf Jungnelius Resigns from Oncopeptides AB (publ) Board of DirectorsOncopeptides AB (publ) announced that Jarl Ulf Jungnelius has informed the Board of Directors of his decision to step down from the Bord of Directors of Oncopeptides in which he has served since 2011. This due to personal reasons related to a change of domicile from Sweden.
お知らせ • Jan 27Oncopeptides' Pepaxti Formally Approves for Full Reimbursement in ItalyOncopeptides AB (publ) announced that the positive reimbursement decision for its drug Pepaxti (melflufen) has been published in the Italian Official Journal ("IOJ", It.: Gazetta Ufficiale). This marks the final regulatory step for the drug's upcoming commercialization in Italy, confirming Oncopeptides' expectation of first sales during first half, 2025. With the IOJ publication, Oncopeptides can now initiate the regional access process to bring Pepaxti to patients. The company's goal is to make the treatment available to eligible Italian patients with relapsed and refractory multiple myeloma over the coming months. Italy reports an annual incidence of approximately 6,000 new cases of multiple myeloma, and with about 1,800 patients falling within Pepaxti's target population. 79 patients across 10 Italian hospitals during the clinical development of Pepaxti and 86 treated patients in the Early Access Program (EAP) underscores the clinical experience in the country and high unmet need for the drug. The Early Access program have been closed following the reimbursement. As previously communicated, Oncopeptides is currently in the process of strengthening its presence in Italy by expanding its team and investing in initiatives to raise awareness about Pepaxti and its benefits.
お知らせ • Jul 04An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million.An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million on July 2, 2024. Industrifonden Foundation has divested its entire stake in Oncopeptides. An undisclosed buyer completed the acquisition of 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden on July 2, 2024.
お知らせ • May 17Oncopeptides AB (publ) Presents New Data Highlighting Treatment Benefits of Pepaxti in High-Risk Multiple Myeloma Patients at the COMy CongressOncopeptides AB (publ) announced that new scientific data on melflufen, branded in Europe as Pepaxti, has been accepted at the 10th annual World Congress on Cont Cont Cont Controversies in Multiple Myeloma (COMy), to be held on May 23-26. The study, published by a team from institutions across Europe, including the University of Wurzburg and the Institute for Molecular Medicine Finland, focuses on the effectiveness of melflufen and shows promising results for the drug when treating patients with a particularly challenging form of multiple myeloma. The study will be presented to congress attendees through an online oral presentation on May 26. The presentation will be given by Caroline Heckman, from the Institute for Molecular Medicine Finland. Multiple myeloma can be especially difficult to treat in patients who have specific genetic mutations or deletions, such as del(17p) and/or mutations in the TP53 gene. These genetic characteristics are associated with a poorer prognosis and shorter survival rates. The research findings indicate that melflufen is more effective than traditional alkylating agents causing DNA damage and promoting the death of cancer cells lacking a functional so-called p53 protein, which is a common issue in high-risk multiple myeloma cases. The study also highlighted significant changes in gene expression that enhance the drug's impact on cancer cells. Furthermore, patients with the del(17p) genetic abnormality treated with melflufen and dexamethasone showed a longer progression-free survival and higher overall response rate compared to those treated with pomalidomide and dexamethasone in the OP-103 OCEAN trial.
お知らせ • Apr 05Oncopeptides AB (Publ) Provides Sales Guidance for the First Quarter of 2024Oncopeptides AB (publ) provided sales guidance for the first quarter of 2024. The company expected net sales to amount to SEK 5.1 million (SEK 1.1 million).
お知らせ • Mar 13Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million.Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: Rights Offering
お知らせ • Feb 24Oncopeptides AB (publ), Annual General Meeting, May 22, 2024Oncopeptides AB (publ), Annual General Meeting, May 22, 2024.
お知らせ • Dec 16Oncopeptides Announces European Commission Decides to Formally Approve its Application to EMA for Extended Indication for Pepaxti into Earlier LinesOncopeptides announced that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains. Oncopeptides has submitted an application to adjust the indication of Pepaxti to the originally approved indication, a process that is expected to be finalized in early 2024. During this time, Oncopeptides will work together with the European Commission, EMA as well as local stakeholders to ensure an efficient removal process for the extended indication.
お知らせ • Nov 18Oncopeptides AB (publ) to Report Q3, 2024 Results on Nov 07, 2024Oncopeptides AB (publ) announced that they will report Q3, 2024 results on Nov 07, 2024
お知らせ • Nov 15Oncopeptides Selects to Present Additional Data from Ocean StudyOncopeptides AB (publ) announced that long-term outcomes from its Phase 3 OCEAN study has been accepted as a poster and will be presented at the 65th annual American Society of Hematology (ASH) Meeting and Exposition. The conference takes place in San Diego between December 9-12. ASH is the world's professional hematologic society serving both clinicians and scientists around the world who are working to conquer blood diseases. The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.
お知らせ • Oct 27Oncopeptides AB (publ) to Report Q2, 2024 Results on Aug 14, 2024Oncopeptides AB (publ) announced that they will report Q2, 2024 results at 8:00 AM, Central European Standard Time on Aug 14, 2024
お知らせ • Oct 21Oncopeptides AB (publ) Announces the Nomination CommitteeOncopeptides AB (publ) announces that the composition of the Nomination Committee has been established. According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2024 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of the end of the third quarter 2023 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors. The Nomination Committee in respect of the annual general meeting 2024 consists of the following persons who together represent approximately 29 percent of the number of shares and votes in the company based on the shareholder information at end of September 2023. Staffan Lindstrand, appointed by HealthCap VI L.P., Patrik Sobocki, appointed by Stiftelsen Industrifonden, Caroline Mebius, appointed by Handelsbanken funds, and Per Wold-Olsen, the Chairman of the Board.
お知らせ • Oct 12Oncopeptides AB (publ) to Report Q1, 2024 Results on May 03, 2024Oncopeptides AB (publ) announced that they will report Q1, 2024 results on May 03, 2024
お知らせ • Oct 02Oncopeptides AB (publ) to Report Fiscal Year 2023 Final Results on Apr 22, 2024Oncopeptides AB (publ) announced that they will report fiscal year 2023 final results on Apr 22, 2024
お知らせ • Sep 21Oncopeptides AB (publ) to Report Fiscal Year 2023 Results on Feb 27, 2024Oncopeptides AB (publ) announced that they will report fiscal year 2023 results on Feb 27, 2024
お知らせ • Sep 15Oncopeptides AB (Publ) Announces Positive Opinion on Type II Variation to Extend the Therapeutic Indication of Pepaxti Based on Ocean Trial ResultsOncopeptides AB (publ) announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has, following their scientific assessment, adopted a positive opinion on Oncopeptides' application for earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM). The opinion from the CHMP will now be sent to the European Commission for a final decision. Based on findings from its OCEAN trial, Oncopeptides submitted, on 28 Nov. 2022, an application to extend the therapeutic indication of Pepaxti to the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy. With their opinion, CHMP recommends that the use of Pepaxti could be expanded to earlier lines of treatment and also peripheral administration, meaning delivery of treatment through peripheral rather than central veins, a less invasive way of administration. Oncopeptides will as a next step assess the current market dynamics of the rapidly evolving multiple myeloma landscape, including the competition in different lines of treatment and the effect that extending Pepaxti into earlier lines of treatment would have on Oncopeptides's ability to receive a reimbursed price that reflects its innovation.
お知らせ • Aug 10Oncopeptides AB (publ) Appoints Henrik Bergentoft as Chief Financial OfficerOncopeptides AB (publ) announced that the company has appointed Henrik Bergentoft as Chief Financial Officer, CFO. Henrik was most recently CFO at RaySearch Laboratories and brings 20+ years of experience from leading finance roles at both medical and non-medical, publicly listed organizations. He will assume his new position during the fourth quarter, replacing Holger Lembrér.
お知らせ • Aug 08+ 1 more updateOncopeptides AB (publ) Announces Sofia Heigis to Move from the CCO Role to CEO RoleOncopeptides AB (publ) announced that Sofia Heigis who will move from the CCO role to take on the CEO role.
お知らせ • Jun 14Holger Lembrér Will Leave Oncopeptides as Chief Financial OfficerOncopeptides AB (publ) announced that Holger Lembrér, Chief Financial Officer (CFO) has decided to leave Oncopeptides to pursue a new role in another company. Holger was appointed CFO in January 2023. He will continue in his current role until December or until a new CFO takes office. A recruitment process will be initiated immediately.
Board Change • Mar 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Mar 09Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 18+ 2 more updatesOncopeptides AB (publ) to Report Q2, 2023 Results on Aug 10, 2023Oncopeptides AB (publ) announced that they will report Q2, 2023 results on Aug 10, 2023
お知らせ • Jan 12Oncopeptides AB (Publ) Announces Chief Financial Officer ChangesOncopeptides AB (publ.) announced that the company has appointed Holger Lembrer as Chief Financial Officer, CFO. Prior to joining the company, Holger Lembrer was Business Unit CFO at Assa Abloy, and before that Investor Relations Officer, and Financial Controller. He has also been a Senior Auditor at Ernst & Young. Holger Lembrer will assume his new position before the end of February 2023 and will replace Annika Muskantor who has been interim CFO since November 1, 2021.
お知らせ • Jan 05Oncopeptides AB (publ) Announces Jakob Lindberg Assumes Chief Scientific OfficerOncopeptides AB (publ) announced that the Board of Directors has appointed Dr. Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer.
お知らせ • Jan 04Oncopeptides AB (Publ) Announces Executive ChangesOncopeptides AB (publ.) announced that the board of directors has appointed Dr. Monica Shaw as chief executive officer of the company. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer. These changes are effective immediately. Dr. Monica Shaw brings a wealth of executive leadership skills from the pharmaceutical industry, e.g., GSK and LEO Pharma, and has a strong track record from bringing more than 15 products through phase III to successful commercialization, globally and across many geographies. She has a broad therapeutic area knowledge from previous positions as a physician and within industry, including Immunology, Oncology, Virology, Neurology and Rare Diseases.
お知らせ • Dec 15Oncopeptides AB (publ) to Report Fiscal Year 2022 Final Results on Apr 25, 2023Oncopeptides AB (publ) announced that they will report fiscal year 2022 final results at 9:00 AM, Central European Standard Time on Apr 25, 2023
Board Change • Nov 29Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Oct 26Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Oct 12Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Sep 21Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Breakeven Date Change • Aug 13Forecast to breakeven in 2024The 2 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 68% per year to 2023. The company is expected to make a profit of kr200.2m in 2024. Average annual earnings growth of 30% is required to achieve expected profit on schedule.
Board Change • Aug 09Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • May 18Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Mar 24Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Mar 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Feb 18Oncopeptides AB (publ) to Report Fiscal Year 2022 Results on Feb 16, 2023Oncopeptides AB (publ) announced that they will report fiscal year 2022 results at 8:00 AM, Central European Standard Time on Feb 16, 2023
お知らせ • Sep 12Oncopeptides AB (Publ) Presents Phase 3 Ocean Study Results At the IMW MeetingOncopeptides AB presents data from the phase 3 OCEAN study, a direct head to head comparison of the efficacy and safety of melflufen plus dexamethasone and pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma, (RRMM), who are refractory to lenalidomide and have received 2-4 prior lines of therapy. The data was presented by Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway, at the 18 International Myeloma Workshop in Vienna. Melflufen met the primary endpoint of superior Progression Free Survival as assessed by the Independent Review Committee (IRC), with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide, a Hazard Ratio (HR) of 0.79, and a p-value of 0.03. The results of key secondary endpoints in the Intention to Treatpopulation were Overall Survival (OS), which favored pomalidomide with a HR of 1.10, and Overall Response Rate, where melflufen had a numerically higher ORR of 33 % compared to 27% for pomalidomide.
お知らせ • Aug 28Oncopeptides AB (publ) Presents New Data from OCEAN and PORT Study - Abstracts OnlineOncopeptides AB (publ) announced that data from the phase 3 OCEAN study has been accepted as an oral presentation at the upcoming 18thInternational Myeloma Workshop (IMW), and the abstract is now available online. More comprehensive data will be presented at the IMW-meeting in Vienna on September 11, at 10:00 (CET). The phase 3 OCEAN study is a head-to-head comparison evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone. Melflufen met its primary endpoint and demonstrated superior Progression Free Survival (PFS) as assessed by the Independent Review Committee (IRC) versus pomalidomide, in patients with relapsed refractory multiple myeloma (RRMM) who are refractory to lenalidomide and have received 2-4 prior lines of therapy, with a Hazard Ratio* (HR) of 0.79, and p-value of 0.03. Overall Survival (OS) was a key secondary endpoint. The HR for OS was 1.10 in favor of pomalidomide in the Intention to Treat (ITT) population. At the IMW Oncopeptides will also present data from the phase 2 PORT study, an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with RRMM.
Recent Insider Transactions • Aug 25Deputy CEO & CFO recently bought kr82k worth of stockOn the 23rd of August, Anders Martin-Löf bought around 2k shares on-market at roughly kr41.18 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr200k. Anders has been a buyer over the last 12 months, purchasing a net total of kr220k worth in shares.
Breakeven Date Change • Jul 30No longer forecast to breakevenThe 5 analysts covering Oncopeptides no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr8.80m in 2023. New consensus forecast suggests the company will make a loss of kr267.4m in 2023.
お知らせ • Jul 15Oncopeptides' Pepaxto Receives Specific C-Code and Pass-Through Payment Status Further Streamlining Reimbursement in Hospital Sites of CareOncopeptides AB (publ) announced that the Centers for Medicare and Medicaid Services (CMS) have established a specific C-Code for PEPAXTO®, C9080. The code went into effect on July 1, 2021, and will be active through June of 2024. C-codes are specific temporary pricing codes established for the Prospective Payment System, exclusively for the Hospital Outpatient setting of care. The c-code, and the transitional pass-through status that it confers, is intended to encourage the use of newly FDA-approved drugs to increase Medicare patients' access to new and innovative therapies by temporarily paying more than established facility fees. Oncopeptides' anticipates a permanent J-Code will be assigned in the third quarter of 2021. PEPAXTO in combination with dexamethasone was approved by the FDA under accelerated approval on February 26, 2021, based upon the HORIZON study for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Breakeven Date Change • Jul 09Forecast to breakeven in 2023The 5 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 32% per year to 2022. The company is expected to make a profit of kr8.80m in 2023. Average annual earnings growth of 67% is required to achieve expected profit on schedule.
Recent Insider Transactions • Jun 03Insider recently bought kr200k worth of stockOn the 28th of May, Fredrik Lehmann bought around 2k shares on-market at roughly kr100.00 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr501k. Despite this recent purchase, insiders have collectively sold kr16m more in shares than they bought in the last 12 months.
お知らせ • May 25+ 1 more updateOncopeptides AB Announces Positive Topline Results from the Head-To-Head Phase 3 Ocean Study Evaluating the Efficacy and Safety of MelflufenOncopeptides AB announced positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results will be presented at a webcast on May 25, 2021, at 11:00 (CET). The PFS, as assessed by the independent review committee, demonstrated a Hazard Ratio favoring melflufen of 0.817 (95% CI: 0.659-1.012, p=0.0640) for the primary endpoint and shows that melflufen is non-inferior to pomalidomide. The Hazard Ratio for PFS as per investigator assessment was 0.790 (95% CI: 0.639-0.976). In both assessments, the median PFS for the melflufen arm was more than 40% higher than for the pomalidomide arm. The Overall Response Rate for melflufen was 32.1% vs. 26.5% for pomalidomide. Pepaxto® (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Breakeven Date Change • May 21Forecast breakeven pushed back to 2024The 5 analysts covering Oncopeptides previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of kr555.0m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
お知らせ • May 21Oncopeptides AB (Publ) Presents Clinical Abstracts on Melflufen At the 2021 American Society of Clinical OncologyOncopeptides AB (publ) announced that three abstracts with data on melflufen (INN melphalan flufenamide) in relapsed refractory multiple myeloma, RRMM, have been accepted by the 2021 American Society of Clinical Oncology, ASCO, and have now been published online. The clinical data presentations include updates on Oncopeptides' ANCHOR and LIGHTHOUSE studies as well as a pooled analysis of the O-12-M1 and HORIZON studies in patients who have been exposed to or become refractory to prior alkylators. Anchor (Op-104): Melflufen Plus Dexamethasone and Bortezomib in Relapsed/Refractory Multiple Myeloma Patients: The ANCHOR study determined that the optimal dose of melflufen is 30 mg plus dexamethasone and bortezomib and the results showed clinical activity in heavily pretreated RRMM patients. Recruitment for this study is ongoing and updated data including efficacy and safety will be presented at ASCO. Lighthouse (Op-108): A Phase 3 Study of Melflufen in Combination with Dexamethasone and Daratumumab in Relapsed/Refractory Multiple Myeloma Patients: A Pooled Analysis of the O-12-M1 and Horizon Studies: Melflufen Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients (Rrmm) Who Are Exposed or Refractory to Prior Alkylators The phase 3 LIGHTHOUSE study is a randomized, controlled, open-label study of melflufen plus dexamethasone in combination with daratumumab vs daratumumab alone in patients with RRMM previously treated with an immunomodulatory agent and a proteasome inhibitor, similar to the indication for daratumumab monotherapy. The primary objective is superiority of PFS. Key secondary endpoints include ORR (= PR), DOR, and safety. Patient recruitment is ongoing with a planned enrolment of 240 patients.
お知らせ • May 13Oncopeptides AB (publ) Presents New Clinical and Preclinical Melflufen Data at the Upcoming European Hematology Association MeetingOncopeptides AB (publ) announced that new clinical and preclinical data have been accepted by the European Hematology Association, EHA, and been published online. The clinical data presentation contains interim results from the phase 2 BRIDGE study supporting the use of melflufen in relapsed refractory multiple myeloma patients with moderately impaired renal function. Two preclinical data presentations show the future potential of melflufen in treatments of other hematological diseases outside multiple myeloma. In addition, the last preclinical data presentation provides an increased understanding of melflufen 's mode of action. Below is a brief description of the abstracts that have been accepted by the EHA. They will be available online at ehaweb.org, from May 12th at 16:00 (CET). 1. BRIDGE (OP-107): A PHASE 2 PHARMACOKINETIC STUDY OF MELFLUFEN PLUS DEXAMETHASONE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA AND IMPAIRED RENAL FUNCTION: The study demonstrates that for patients receiving melflufen in the phase 2 BRIDGE study, the exposure to melphalan increased with reduced eGFR (Estimated Glomerular Filtration Rate), similar to what is observed during treatment with melphalan. The overall toxicity profile was as expected for melflufen and dexamethasone and no new safety signals were observed, supporting the use of melflufen in patients with moderate renal impairment. 2. MELFLUFEN DEMONSTRATES HIGH EFFICACY IN CYTARABINE AND VENETOCLAX RESISTANT AML MODELS: The study shows that multiple aminopeptidases are highly expressed in AML-samples, providing a good rationale for using melflufen therapy. Patients with Acute Myeloid Leukemia, often develop resistance to current treatments, including cytarabine and venetoclax, yet in pre-clinical models of resistance to these agents, melflufen shows high efficacy. 3. MELPHALAN FLUFENAMIDE IS A HIGHLY POTENT ANTI-NEOPLASTIC AGENT IN HIGH RISK DLBCL MODELS: Several aminopeptidase genes are highly expressed in samples of patients with DLBCL, Diffuse Large B-Cell Lymphoma, and their elevated expression is associated with significantly shorter survival. In preclinical in vitro tests of DLBCL cell lines, melflufen shows superior cytotoxicity compared to Standard of Care drugs doxorubicin and bendamustine. 4. MELFLUFEN RAPIDLY ACCUMULATES WITHIN TUMOR CELLS AND DISTRIBUTES AN ALKYLATING PAYLOAD TO THE NUCLEUS AND MITOCHONDRIA: The increased lipophilicity of melflufen can affect the redistribution of the alkylating payload within the cell. Data show that melflufen, but not melphalan, localized significantly within lysosomes, endoplasmic reticulum and importantly mitochondria, which may affect the mechanism of cancer cell killing. PEPAXTO. (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
お知らせ • May 06Oncopeptides AB Completes Patient Enrollment in Phase 2 Port StudyOncopeptides AB announced that the Company has completed patient enrollment in the phase 2 PORT study. The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma. Oncopeptides expects topline data in third quarter of 2021.
Recent Insider Transactions • Mar 18Chief Scientific Officer recently sold kr16m worth of stockOn the 10th of March, Jakob Lindberg sold around 100k shares on-market at roughly kr158 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr17m more than they bought in the last 12 months.
お知らせ • Mar 16Oncopeptides Announces Commercial Availability of PEPAXTO®Oncopeptides AB (publ) announced that PEPAXTO® (melphalan flufenamide) is now commercially available and that the first patients are being treated with the drug. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The company is committed to working with payers and healthcare providers across the United States to help ensure that all patients prescribed PEPAXTO have access to it. The company has established a Patient Assistance Program called ON COURSE for people who may not have access to health insurance or have an insurance plan that does not cover the entire cost of the medication. Some restrictions apply and patients need to meet certain eligibility criteria. Additionally, the ON COURSE team offers benefits verification, prior authorization assistance, claims management and appeals. The ON COURSE team is comprised of nurse case managers that offer personalized attention through the treatment process including helping patients and caregivers connect to support groups and organizations in the multiple myeloma community.
お知らせ • Mar 12Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 1.1218 billion.Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 1.1218 billion. Security Name: Shares Security Type: Common Stock Securities Offered: 7,100,000 Price\Range: SEK 158 Transaction Features: Subsequent Direct Listing
お知らせ • Mar 09Oncopeptides AB (Publ) Announces Executive ChangesOncopeptides AB (publ) announced that it strengthens the leadership of the European operations by appointing Andrea Passalacqua as General Manager in Europe, and Pamela Bacon as Head of Medical Affairs Europe. As previously announced, Oncopeptides will also seek a Conditional Marketing Authorization of melphalan flufenamide in triple class refractory multiple myeloma, during second quarter of 2021. In his capacity as General Manager in Europe, Andrea Passalacqua will be part of the global Leadership Team of Oncopeptides AB. Andreas brings extensive commercial experience from Amgen and Celgene in multiple myeloma, and most recently he served as General Manager in Italy for Bluebird Bio. Pamela Bacon carries a significant proficiency in the multiple myeloma space and has an in-depth experience from several global Medical Affairs roles within Celgene and Amgen.
お知らせ • Feb 27Oncopeptides AB (publ) Receives U.S. Food and Drug Administration Approval for PEPAXTO for Patients with Relapsed or Refractory Multiple MyelomaOncopeptides AB (publ) announced that the U.S. Food and Drug Administration, FDA, has approved PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The company will begin promoting PEPAXTO to healthcare professionals across the U.S. immediately and expects a labeled product in distribution centers and specialty pharmacies within approximately two weeks. PEPAXTO is the first anticancer peptide-drug conjugate approved by the FDA. The product has been granted accelerated approval based on the phase 2 HORIZON study in relapsed or refractory multiple myeloma. The HORIZON study evaluating intravenous melflufen in combination with dexamethasone, included heavily pre-treated patients with a poor prognosis. This multi-center single arm study evaluated 157 patients with relapsed or refractory multiple myeloma, of whom 97 were triple-class refractory and had received at least four prior lines of treatment. The Overall Response Rate for the patients within this group of patients with refractory multiple myeloma was 23.7% and the Median Duration of Response was 4.2 months. Furthermore, melflufen in combination with dexamethasone demonstrated activity in a subset of patients with Extra Medullary Disease (41%), an aggressive and resistant disease associated with a poor prognosis.
Is New 90 Day High Low • Feb 26New 90-day high: kr180The company is up 18% from its price of kr152 on 27 November 2020. The British market is up 6.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 27% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is kr3.52 per share.
お知らせ • Feb 13+ 1 more updateOncopeptides AB (publ) to Report Q2, 2021 Results on Aug 26, 2021Oncopeptides AB (publ) announced that they will report Q2, 2021 results on Aug 26, 2021
Recent Insider Transactions • Jan 20Insider recently sold kr772k worth of stockOn the 15th of January, Fredrik Lehmann sold around 5k shares on-market at roughly kr166 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.
お知らせ • Dec 23Oncopeptides Enrolls the First Patient in the Phase 3 LIGHTHOUSE Combination Study in Multiple MyelomaOncopeptides AB (publ) announced that the first patient has been dosed in the phase 3 LIGHTHOUSE study, evaluating the efficacy and safety of a triple combination therapy with melflufen plus dexamethasone and subcutaneous daratumumab compared to daratumumab alone. The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.
お知らせ • Dec 17Oncopeptides AB Appoints Linda Holmström as Director of Investor RelationsOncopeptides AB announced that Linda Holmström has been appointed Director of Investor Relations. Linda has more than 15 years of experience from the life science industry. Prior to joining Oncopeptides she held the position as Senior Corporate Communications and Investor Relations Manager at Sobi, Swedish Orphan Biovitrum AB (publ). Linda assumes the responsibility for Investor Relations. Rein Piir who has been responsible for the Investor Relations function during the last four years will continue to work as a senior advisor.
お知らせ • Dec 11+ 1 more updateOncopeptides AB (Publ) Announces That the Pivotal Phase 2 HORIZON Study Evaluating Intravenous Melflufen (INN Melphalan Flufenamide) in Combination with Dexamethasone in Relapsed Refractory Multiple Myeloma, Has Been Published in the Peer-Reviewed Journal of Clinical OncologyOncopeptides AB (publ) announced that the pivotal phase 2 HORIZON study evaluating intravenous melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma, has been published in the peer-reviewed Journal of Clinical Oncology. The phase 2 HORIZON data are the basis for the ongoing priority review of the New Drug Application to the US Food and Drug Administration FDA, for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma patients, who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody. The phase 2 HORIZON study is a pivotal, single-arm, multicenter, phase 2 study evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma. The study included 157 heavily pretreated patients, who had received >2 earlier lines of therapy with immunomodulatory drugs and proteasome inhibitors and were refractory to pomalidomide and/or daratumumab. The HORIZON study population includes subgroups of patients who were triple-class refractory and/or had extramedullary disease and/or had cytogenetic high-risk features.
お知らせ • Nov 20+ 1 more updateOncopeptides AB (publ) to Report Q1, 2021 Results on May 26, 2021Oncopeptides AB (publ) announced that they will report Q1, 2021 results on May 26, 2021
お知らせ • Nov 06Oncopeptides AB (publ) Announces New Data for Melflufen Accepted for Presentation at the Annual American Society of Hematology MeetingOncopeptides AB (publ) announced that twelve abstracts, including one oral presentation, have been accepted for the upcoming virtual American Society of Hematology (ASH) meeting on December 5-8, 2020. Key clinical abstracts focus on data from the ongoing phase 1/2 ANCHOR combination study and the pivotal phase 2 HORIZON study. The preclinical abstracts further explore the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma. The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma and sets the foundation for the planned phase 3 LIGHTHOUSE daratumumab combination study. Seven clinical abstracts are based on the HORIZON study, most notable are the subgroup analysis of patients exposed to and refractory to alkylators and the analysis of patients with extramedullary disease, that further verify the distinct mechanism of action of melflufen. Melflufen (INN Melphalan flufenamide) is an investigational first-in-class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is in late-stage clinical development for the treatment of patients with triple-class refractory multiple myeloma and has recently been granted a priority review by the U.S. Food and Drug Administration, FDA, for a New Drug Application based on the results from the phase 2 HORIZON study.
お知らせ • Oct 19Oncopeptides AB (publ) Submits Investigational New Drug application to FDA for the second drug candidate from the PDC platformOncopeptides AB (publ) announced that the company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC). Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma. The specific formulation enables administration of high doses which provides a clear rationale for treatment of this patient group. OPD5 is based on the proprietary PDC platform. Peptide-drug conjugates leverages aminopeptidases and releases alkylating agents rapidly into tumor cells. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden.
お知らせ • Oct 13Oncopeptides AB (publ) Intents to File for Conditional Approval of Melflufen with EMAOncopeptides AB (publ) announced that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM). The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await the results from the ongoing randomized, phase 3 OCEAN study before submitting an application for marketing authorization. Upon completion, the outcome from the OCEAN study comparing melflufen and pomalidomide in patients with RRMM, will be submitted to regulatory authorities to potentially expand the label of melflufen. The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD). According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if; the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data. The US Food and Drug Administration, FDA, has granted priority review to Oncopeptides' New Drug Application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA has set a target date for the review of the New Drug Application, to February 28, 2021.
お知らせ • Oct 04Oncopeptides initiates U.S. Expanded Access Program with melflufen in triple-class refractory multiple myelomaOncopeptides AB (publ) announced that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The Expanded Access Program was initiated following the Company's June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma. The NDA and the sEAPort program are primarily supported by data from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma who are hard to treat and have a poor prognosis, including patients with triple-class refractory multiple myeloma and patients with extramedullary disease. EAPs are designed to provide patients living with serious or life-threatening conditions access to investigational medicines when no comparable or satisfactory treatment options are available, alternative therapies have been exhausted or the patient is ineligible for ongoing interventional trials. Forty to fifty medical sites in the U.S. are expected to enroll 100-200 patients in the sEAPort program.
