Announcement • Jul 20
Medivir Receives Notice of Allowance for Fostrox Plus Lenvatinib Combination Patent in the Usa Medivir AB announced that it has received a Notice of Allowance by the United States Patent and Trademark Office (USPTO) for the company's patent application covering claims for the combination of fostroxacitabine bralpamide (fostrox) with lenvatinib for the treatment of hepatocellular carcinoma (HCC) and cancer metastases to the liver. This adds to the previous approvals in EU, Japan, Australia and Canada. The Notice of Allowance indicates that the USPTO intends to grant the application once standard procedural steps have been completed. The fostrox plus lenvatinib combination patent provides protection and market exclusivity until at least April 2041. Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel inactive to the liver where activation and release takes place locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with primary liver cancer and liver metastases from other tumor types. A phase 1b monotherapy study with fostrox has previously been conducted that established clinical proof-of-concept. A phase 1b/2a combination study with fostrox in combination with Lenvima in advanced HCC was completed in November 2024, where data showed encouraging anti-cancer efficacy with a good safety and tolerability profile. Announcement • Mar 07
Medivir AB Appoints Patrik Norgren as Chief Financial Officer, Effective March 23, 2026 Medivir AB has appointed Patrik Norgren as Chief Financial Officer. He will assume his role on March 23, 2026. Norgren most recently served as CFO of the Swedish pharmaceutical company Cinclus Pharma. He brings over 20 years of extensive experience in CFO and senior financial leadership roles across both private and publicly listed companies. Announcement • Feb 18
Medivir AB (publ) to Report Nine Months, 2026 Results on Nov 05, 2026 Medivir AB (publ) announced that they will report nine months, 2026 results on Nov 05, 2026 Announcement • Feb 10
Medivir AB (publ) announced that it has received SEK 45 million in funding from Carl Bennet AB On February 9, 2026, Medivir AB (publ) closed the transaction. Announcement • Jan 29
Medivir AB (publ), Annual General Meeting, May 07, 2026 Medivir AB (publ), Annual General Meeting, May 07, 2026. Announcement • Jan 15
Medivir AB (Publ) Appoints Anders Hallberg as Ordinary Board Member and Chairman of the Board Medivir AB held an extraordinary general meeting on January 14, 2026. The extraordinary general meeting resolved that the board shall consist of four ordinary board members without deputies. Anders Hallberg was elected as ordinary board member for the period until the next annual general meeting, with Anders Hallberg as chairman of the board. Announcement • Oct 09
Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 151.426537 million. Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 151.426537 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 336,503,415
Price\Range: SEK 0.45
Transaction Features: Rights Offering Announcement • Jul 10
Medivir AB Receives Notice of Allowance for Fostrox Plus Lenvatinib Combination Patent by Japan Patent Office Medivir AB announced that it has received a Notice of Allowance by the Japan Patent Office (JPO) for the company's patent application covering claims for the combination of fostroxacitabine bralpamide (fostrox) with lenvatinib (L envima) for the treatment of hepatocellular carcinoma (HCC) and cancer metastases to the liver. This adds to the recent approval by the Australian Patent Office (IP Australia) and the previously communicated European Unitary patent approval. The Notice of Allowance indicates that the JPO intends to grant the application once standard procedural steps have been completed. The fostrox plus Lenvima combination patent provides protection and market exclusivity until April 2041. Announcement • Mar 28
Medivir AB (publ), Annual General Meeting, May 07, 2025 Medivir AB (publ), Annual General Meeting, May 07, 2025, at 14:00 W. Europe Standard Time. Location: at 7a odenplan, norrtullsgatan 6, stockholm Sweden Announcement • Feb 18
Medivir AB (publ) to Report Nine Months, 2025 Results on Nov 06, 2025 Medivir AB (publ) announced that they will report nine months, 2025 results on Nov 06, 2025 Announcement • Dec 16
Medivir AB Obtains IND Approval for Fostrox - the Firstoral, Liver-Targeted Treatment for Advanced Liver Cancer Medivir AB announced the approval of the US Investigational New Drug application (IND) for evaluating fostrox + Lenvima vs Lenvima alone in a phase 2b study in 2nd line advanced HCC. The randomized phase 2b study will evaluate the combination of fostrox + Lenvima vs Lenvima alone in second-line advanced HCC patients who have previously been treated with an immunotherapy combination. The primary endpoint is Objective Response Rate with secondary endpoints including duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and Quality of Life. Principal Investigator of the study is Prof. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and one of the most renowned global experts in the field of liver cancer. Announcement • Nov 28
Medivir AB Announces Finalisation of the Phase 1B/2A Study of fostroxacitabine bralpamide Medivir AB announced that the phase 1b/2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in 2nd or 3rd line advanced liver cancer (HCC), closed on November 26th. The 3 remaining patients in the study have been transferred to compassionate use, allowing continued benefit from the treatment. At the ESMO congress in Barcelona in September, the company presented positive, mature data showing an encouraging tolerability profile and improved outcomes beyond what can be expected from current alternatives in second-line advanced HCC. Patients in the study showed extended duration of benefit, resulting in longer than expected treatment time, as evidenced by a median Time to Progression of 10.9 months. This is substantially longer than previously seen in second-line HCC. With the study now closed, the company plans to present end-of-treatment data at an upcoming scientific congress. The objectives of the phase 1b/2a study, evaluating safety and preliminary efficacy of fostrox in combination with Lenvima, were met. Mature data presented at ESMO this year showed that the combination is safe and tolerable with encouraging anti-tumor activity. These results indicate improved outcomes beyond current second-line alternatives in advanced HCC and with a compassionate use program in place, the remaining patients can continue benefitting from the treatment. Announcement • Oct 23
Medivir AB (Publ) Appoints Nomination Committee Medivir AB (publ) announced that the composition of its Nomination Committee is now completed, and this year’s Nomination Committee consists of:
Karl Tobieson, appointed by Linc AB; Richard Torgerson, appointed by Nordea Funds AB; Anders Hallberg, appointed by Hallberg Management AB; Uli Hacksell, Chairman of the Board, Medivir AB. Announcement • Sep 16
Medivir Presents Positive, Mature Data from its Ongoing Phase 1b / 2a Study of fostroxacitabine bralpamide (fostrox) + Lenvima in Advanced Liver Cancer (hepatocellular carcinoma/HCC) at the European Society of Medical Oncology Congress Medivir AB (publ) presented positive, mature data from its ongoing phase 1b /2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced liver cancer (hepatocellular carcinoma/HCC) at the ESMO (European Society of Medical Oncology) Congress in Barcelona, Spain. On September 16, 2024’s ESMO update, poster number 986P, presented by Dr. Hong Jae Chon on September 16, shows promising duration of benefit with 19% of patients continuing treatment for more than a year and the longest running patient remaining on treatment for over 2 years, with sustained partial response. The patients in the study had disease control on fostrox + Lenvima independent if they benefitted from previous line of therapy, showing potential for all second-line patients to benefit from the combination. The safety and tolerability profile continues to be encouraging with no unexpected adverse events. While hematological adverse events were common, they were temporary in nature. Decreases in neutrophil & platelet counts showed a cyclic pattern with recovery before next cycle of treatment, enabling patients to remain on treatment long-term. Importantly, no patient experienced febrile neutropenia or low platelet count with bleeding and there were no fostrox-related serious adverse events. Results come despite very poor prognosis for most second-line HCC patients on September 16, 2024, with just 5% - 10% responding to current standard of care treatment, and a typical TTP of only 3 - 4 months. The data are from Medivir's ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. Announcement • Sep 12
Medivir AB to Present Mature Clinical Data for Fostrox + Lenvima at ESMO Conference Medivir AB has previously announced that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 16, 2024. The abstract, titled "Fostrox (fostroxac itabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma ("HCC") progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a studies." will be presented by Dr. Hong Jae Chon, CHA Bundang Medical Center in Korea. After the presentation Medivir will also host a webcast where Dr. Chon and Dr. Pia Baumann, Chief Medical Officer at Medivir, will present the data and answer questions. In addition to the presentation of phase 1b/2a data, Dr. Chon with his experience of treating liver cancer patients, will provide additional context to the data by comparing with what can be expected with current clinical practice in second-line. Announcement • Jul 18
Medivir AB to Present Updated Clinical Data for Fostrox + Lenvima in Hepatocellular Cancer At ESMO Conference in September Stockholm Medivir AB announce that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 13-17, 2024. Updated clinical data from the ongoing phase 1b/2a study with fostrox in combination with Lenvima. will be presented. As patients are able to stay on treatment long-term, it enables a detailed update on the safety and tolerability profile and how it evolves over time. The presentation will also include additional updates on efficacy endpoints. Announcement • Jun 27
Medivir AB Presents Positive New Data from Its Ongoing Phase Ib / IIa Study of Fostroxacitabine Bralpamide (Fostrox) + Lenvima® in Advanced Hepatocellular Carcinoma (HCC) Medivir AB presented positive new data from its ongoing phase Ib /IIa study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced hepatocellular carcinoma (HCC) at the ESMO GI (European Society of Medical Oncology, Gastrointestinal Cancers Congress in Munich, Germany. ESMO GI update, poster number 176P, is being presented by Dr Hong Jae Chon on June 27, shows: An overall response rate (ORR) of 24%, with a disease control rate (DCR) of 81%, while the median TTP is now 10.8 months, with 25% of patients still on treatment; One patient remains on treatment after 22 months, benefiting from a sustained partial response; Biopsies confirm selective DNA damage to tumor cells, while there is no impact on normal liver function as measured by ALT/AST levels and stable ALBI score over time. The lack of impact on normal liver function supports the previously reported encouraging safety and tolerability profile, where only 5% of patients had to discontinue due to adverse events and the need for dose modification was lower than expected. The data are from Medivir's ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. HCC is the most common type of liver cancer, accounting for more than 80% of cases worldwide. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20%. Announcement • Jun 19
Medivir Selects Global CRO Partner for Upcoming Phase 2B Study in HCC with fostrox + Lenvima and Initiates Study Feasibility Medivir AB announced that it has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima®? vs Lenvima alone in second line HCC. In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second line advanced HCC with the aim of becoming the first, approved treatment alternative after current first line treatment. The study is planned to enroll patients broadly in the US, EU and Asia, building on countries and sites participating in currently ongoing phase 1b/2a, which will ensure that recruitment requirements for a potential accelerated or conditional approval are fulfilled. A key next step is to initiate study feasibility to identify optimal sites and investigators to enable study start in early 2025. Already now, the company have received high level of interest from experts in HCC regarding potential participation in the study. Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing harmful effects on normal livercells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in advanced HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile. Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. The unmet medical need is especially high in second line where there are no approved treatments post first line standard of care. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20%. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. Announcement • May 08
Medivir Aktiebolag (publ) Approves Board Appointments Medivir Aktiebolag (publ) at its annual general meeting held on 7 May 2024, approved to elect Angelica Loskog and Anna Törner as new members of the board of directors. Board Change • Feb 22
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. No highly experienced directors. Independent Director Bengt Westermark is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Feb 15
Medivir AB (publ) to Report Q3, 2024 Results on Nov 06, 2024 Medivir AB (publ) announced that they will report Q3, 2024 results on Nov 06, 2024 Announcement • Oct 26
Medivir AB (publ) to Report Fiscal Year 2023 Results on Feb 15, 2024 Medivir AB (publ) announced that they will report fiscal year 2023 results on Feb 15, 2024 Announcement • Oct 23
Medivir AB (publ), Annual General Meeting, May 07, 2024 Medivir AB (publ), Annual General Meeting, May 07, 2024.