Annuncio • Jun 02
Orion Pharma Announces First Results From Phase 1/2 TEADES Trial With TEAD Inhibitor ODM-212 In Patients With Advanced Solid Tumours Orion Pharma announced first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%). Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate1, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate2, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026. Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction in Hippo pathway. The trial will include patients who have progressed despite available standard treatments and with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at oncology centers in the US and Europe. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Annuncio • May 13
Orion Corporation Receives Us Fda Approval for Tessie (Tasipimidine Oral Solution) for Treatment of Noise Aversion and Separation Anxiety in Dogs Orion Corporation announced that on 6 May 2026 the U.S. Food and Drug Administration (FDA) has approved Tessie (tasipimidine) oral solution for dogs. Tessie is indicated for the treatment of noise aversion and separation anxiety in dogs. Tasipimidine is an Orion proprietary molecule and a new active substance for veterinary use in the U.S. It acts in the central nervous system by blocking the startle reflex and thus counteracting arousal. Orion’s long-standing strategic partner, Zoetis, has the exclusive right to market and sell Tessie in the United States. Tessie is anticipated to be available in the U.S. by mid-2027 and will expand Zoetis' behavioral product portfolio, alongside Sileo and Bonqat. Annuncio • Apr 29
Orion Corporation Announces Composition of Nomination Committee, Effective Date of the Appointments Is April 27, 2026 Orion Corporation announced that the Board of Directors has appointed Annika Ekman, Petteri Karttunen, Risto Karvonen, Veli-Matti Mattila, Hilpi Rautelin, and Seppo Salonen to the Nomination Committee of the company. Hilpi Rautelin was appointed as Chair of the Committee. The duty of the committee is to prepare and present a recommendation to the Board of Directors for a proposal to the Annual General Meeting of shareholders concerning the composition and compensation of the Board. The essentials of the charter of the Nomination Committee and a description of the appointment process of its members are provided at a page in the Corporate Governance section of the Orion Group website. The effective date of the appointments is April 27, 2026. Annuncio • Apr 26
Orion Oyj Revises Earnings Guidance for the Full Year 2026 Orion Oyj revised earnings guidance for the full year 2026. For the year, Net sales are estimated to be EUR 1,950 million to EUR 2,100 million. Operating profit is estimated to be EUR 600 million to EUR 750 million as compared to previously announced Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. Due to the solid start of the year, the company have specified outlook for 2026 by narrowing both the net sales and operating profit ranges from the lower end. First Quarter laid a good foundation for the year. Annuncio • Apr 25
Orion Corporation Initiates Teadco Phase 1b/2 Basket Trial Evaluating Odm-212 In Combination With Standard Of Care Treatments In Patients With Select Advanced Solid Tumours Orion Corporation (Orion Pharma) announced the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer. The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications. The first cohort of the TEADCO trial evaluates ODM-212 in combination with ipilimumab and nivolumab as a first-line treatment for patients with advanced malignant pleural mesothelioma. ODM-212 has the potential to both exert direct anti-tumour activity and prevent emergence of treatment resistance to standard of care therapies in this indication. The second cohort evaluates ODM-212 in combination with sotorasib, a targeted KRAS inhibitor, for the treatment of NSCLC in patients with KRAS G12C mutation. This arm has two sub-cohorts: patients who have been previously treated with KRAS G12C inhibitor and patients who have not received KRAS G12C inhibitor as a prior treatment. ODM-212 has the potential to prevent or overcome treatment resistance to approved KRAS inhibitors in this setting. The third cohort evaluates ODM-212 in combination with chemotherapy (nab-paclitaxel/gemcitabine) for the treatment of metastatic adenocarcinoma of the pancreas aiming to improve treatment efficacy through combination therapy. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Annuncio • Apr 21
Orion Pharma’S Odm-212 Granted Orphan Drug Designation in Mesothelioma by the US FDA Orion Corporation announced that its investigational drug ODM-212 has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of mesothelioma, which is a rare and difficult to treat cancer. The FDA grants orphan drug designation to investigational therapies addressing rare diseases or conditions that affect fewer than 200,000 people in the US. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe. Orphan Drug Designation is granted by FDA to therapies intended to prevent, diagnose, or treat rare diseases or conditions. With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including tax credits, exepmption from user fees, and eligibility for a 7-year period of market exclusivity following approval. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Annuncio • Apr 01
Orion Corporation Appoints Berkeley Vincent as Executive Vice President, Innovative Medicines and A Member of the Orion Executive Team as of 8 April 2026 Orion Corporation (“Orion”) has appointed Berkeley Vincent as Executive Vice President, Innovative Medicines and a member of the Orion Executive Team as of 8 April 2026. The appointment is part of a leadership structure change in which the previously combined role of R&D and Innovative Medicines is split into two dedicated positions. This change reflects the continued growth and maturation of Orion’s Innovative Medicines pipeline and the increasing need to strengthen focus on global commercialization readiness. Outi Vaarala will continue in her role as Executive Vice President, R&D, and as a member of the Orion Executive Team. In his new role, Berkeley Vincent will be responsible for defining and implementing global commercialization strategies for Orion’s Innovative Medicines portfolio. His responsibilities include full P&L ownership, global launch sequencing, market access strategy, and the development of strategic partnerships, including licensing and acquisitions. He will work closely with R&D leadership to align development priorities with commercial and market needs. Berkeley Vincent brings more than 20 years of international pharmaceutical industry experience from senior global, regional and country leadership roles at Johnson & Johnson. Most recently, he served as President, Johnson & Johnson Innovative Medicines Canada, with full P&L responsibility. He has previously held roles including Managing Director of the Nordic cluster and Global Commercial Leader for IMBRUVICA. Berkeley Vincent: Born 1977, Irish and Swedish citizen. Education: MBA, DePaul University, Chicago, 2002, BSc (Management), Trinity College Dublin, 1999. Career: 2022– President, Johnson & Johnson Canada, 2019–2022 Nordics Managing Director, Johnson & Johnson, 2018–2019 Vice President, Customer Digital Strategy, Johnson & Johnson, EMEA, 2015–2018 Regional Strategy Leader, Johnson & Johnson, EMEA, 2012–2015 Global Commercial Leader IMBRUVICA, Johnson & Johnson, 2002–2012 Various commercial and leadership roles, Johnson & Johnson. Annuncio • Jan 14
Orion Oyj Provides Earnings Guidance for the Full Year 2026 Orion Oyj provides earnings guidance for the full year 2026. For the year, Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. Annuncio • Jan 08
Orion Pharma Announces Initiation of Really Irrelevant Phase 2 Trial of ODM-212 in Malignant Pleural Mesothelioma and Epithelioid Hemangioendothelioma (EHE) Orion Corporation announced initiation of a Phase 2 trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, as a monotherapy in malignant pleural mesothelioma (MPM) and epithelioid hemangioendothelioma (EHE), which are rare and difficult to treat cancers. The Phase 2 study is designed to further evaluate the efficacy, safety, dose and tolerability of ODM-212 in a patient population with significant unmet need where current treatment options are limited and outcomes remain poor. The first patient in the study was treated in December 2025. The TEADES trial is a Phase 2 multi-center, open-label study that will enroll approximately 300 patients with MPM, EHE or other solid tumors with dysfunction in Hippo pathway. The trial will include patients who have progressed after receiving standard treatments and have no further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe. ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway--particularly through YAP/TAZ activation--can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity. Malignant Pleural Mesothelioma (M PM) is a rare and aggressive cancer that originates in the pleura--the thin membrane lining the lungs and chest wall. It accounts for about 80-90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy. Epithelioid Hemangioendotheliomas (EHE) is an ultra-rare vascular tumor or abnormality that arises from the cells lining the blood vessels. It is estimated that less than one per million people are living with this rare cancer. Currently there is no standard treatment for EHE. Annuncio • Dec 04
Orion Oyj Updates Earnings Guidance for the Full Year 2025 Orion Oyj updated earnings guidance for the full year 2025. For the year, the company now expects Net sales are estimated to be EUR 1,820 million to EUR 1,900 million and Operating profit is estimated to be EUR 590 million to EUR 670 million against previous guidance of Net sales are estimated to be EUR 1,640 million to EUR 1,720 million and Operating profit is estimated to be EUR 410 million to EUR 490 million. Annuncio • Oct 28
Orion Oyj Provides Earnings Outlook for 2025 Orion Oyj provided earnings outlook for 2025. For the period, the expects net sales to be EUR 1,640 million to EUR 1,720 million against EUR 1,630 million to EUR 1,730 million previously forecasted and Operating profit is estimated to be EUR 410 million to EUR 490 million against EUR 400 million to EUR 500 million previously forecasted. Annuncio • Oct 02
Orion Corporation Announces Phase 2 Study of ODM-105 in Insights Do Not Meet Primary Goal Orion Corporation announced that its candidate ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia. According to the study results, ODM-105 did not significantly improve insomnia-related symptoms such as time to fall asleep or sleep duration compared with placebo. ODM-105 was generally safe and well tolerated. Detailed results, including safety data, and their assessment are to be finalized. Annuncio • Jul 10
Orion Oyj Upgrades Earnings Guidance for Full-Year 2025 Orion Oyj upgraded earnings guidance for full-year 2025. For the period, the company expects net sales are estimated to be EUR 1,630 million to EUR 1,730 million against Net sales to be EUR 1,550 million to EUR 1,650 million in previous full-year outlook and Operating profit is estimated to be EUR 400 million to EUR 500 million against Operating profit to be EUR 350 million to EUR 450 million in previous full-year outlook. Annuncio • Jun 20
Orion Corporation Recommends Third Indication for Darolutamide for Patients with Advanced Prostate Cancer Orion Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The CHMP recommendation is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P1 In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040. Annuncio • Jun 05
U.S. FDA Approves Third Indication of Darolutamide for Patients with Advanced Prostate Cancer Orion Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mHSPC), which is also known as metastatic hormone-sensitive prostate cancer (m HSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001) in patients with mHSPC. With this approval, darolutamide plusADT is indicated in the U.S. for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040. Darolutamide, under the brand name Nubeqa®?, is already approved in combination with ADT and docetaxel in over 85 markets around the world. It's also approved in combination with ADT for the treatment of patients with non-metastastatic castration-resistant breast cancer (nmCRPC). An approval process in the EU for the treatment of mHSPC in combination with ADT (without docetaxel) is already underway by Bayer. Nubeqa achieved blockbuster status in September 2024, with annual sales reported by Bayer reaching EUR 1.52 billion for the full year of 2024. Darolutamide is developed jointly by Orion and Bayer. About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus adT in patients with mHSP C. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Annuncio • Apr 04
Orion Corporation Approves Dividend for the Financial Year Ended 31 December 2024, Payable on 14 April 2025 and 23 October 2025, Respectively Orion Corporation at its AGM held on April 3, 2025, resolved, in accordance with the proposal by the Board of Directors, that a dividend of EUR 1.64 per share will be paid on the basis of the Balance Sheet confirmed for the financial year that ended on 31 December 2024. The dividend is paid in two instalments. The record date for the first instalment of EUR 0.82 per share is 7 April 2025 and the payment date is 14 April 2025. The record date for the second instalment of EUR 0.82 per share is 16 October 2025 and the payment date is 23 October 2025. In addition, the AGM authorised the Board of Directors to resolve, if necessary, on a new record date for payment and payment date for the second instalment of the dividend in case of changes in the rules of Euroclear Finland Oy or the regulations regarding the Finnish book-entry system or if other rules binding the Company so require. Annuncio • Apr 03
Orion Corporation Announces Composition of R&D Committee Orion Corporation at its organising meeting, the Board of Directors of the company, which was elected by the Annual General Meeting of the Shareholders announced the compositions of the Board committees. R&D Committee: Hilpi Rautelin, Chairman, Kari Jussi Aho, Eija Ronkainen and Karen Lykke Sørensen. Personnel and Remuneration Committee: Veli-Matti Mattila, Chairman, Kari Jussi Aho, Maziar Mike Doustdar and Hilpi Rautelin. Audit Committee: Ari Lehtoranta, Chairman, Eija Ronkainen, Henrik Stenqvist and Karen Lykke Sørensen. Annuncio • Feb 27
Orion Oyj Proposes Dividend for the Financial Year Ended 31 December 2024, Payable on 14 April 2025 and 23 October 2025 Orion Oyj at the the Annual General Meeting to be held on 3 April 2025, the Board of Directors proposed that a dividend of EUR 1.64 per share be paid on the basis of the Balance Sheet confirmed for the financial year that ended on 31 December 2024. No dividend shall be paid on treasury shares held by the Company on the record date for dividend payment. According to the proposal, the dividend would be paid in two instalments. The first instalment of EUR 0.82 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 7 April 2025, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the first instalment would be paid on 14 April 2025. The second instalment of EUR 0.82 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 16 October 2025, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the second instalment would be paid on 23 October 2025. Annuncio • Feb 26
Orion Oyj Provides Earnings Guidance for the Year 2025 Orion Oyj provided earnings guidance for the year 2025. For the year, net sales are estimated to be EUR 1,550 million to EUR 1,650 million and Operating profit is estimated to be EUR 350 million to EUR 450 million. Annuncio • Dec 20
Orion Corporation Announces Change in Group Executive Management Board Orion Corporation announced that Olli Huotari, Senior Vice President responsible for Corporate Functions organization of the Orion Group and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group informed earlier of his decision to leave Orion on 31 May 2025. Mikko Kemppainen has been appointed as General Counsel and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group as of 1 June 2025. The appointed General Counsel Mikko Kemppainen will be responsible for the following of Olli Huotari’s responsibility areas: Compliance, Intellectual Property Rights, Legal Affairs, and Public Affairs. Other responsibility areas of Huotari will be transferred to other members of the Executive Management Board of the Orion Group as of June 1, 2025. Mikko Kemppainen holds a Master of Laws (Trained at the Bench) degree. He joined Orion as a Legal Counsel in 2006 and has been the Head of Legal Affairs at Orion Corporation since 2007. Prior to joining Orion, Kemppainen worked as Associate and Senior Associate at Hannes Snellman Attorneys Ltd. during 2000-2006. Annuncio • Oct 25
Orion Corporation Decides to Terminate the ODM-111 Development Program Orion Corporation has decided to terminate the ODM-111 development program based on the risk-benefit analysis on the results of a longer non-clinical toxicology study. Recent findings indicate that the profile of the ODM-111 molecule does not support long-term use of ODM-111 and progression to later-stage development. Additionally, it is important to note that both prior non-clinical studies and the clinical Phase I trial with shorter durations of exposure to ODM-111 did not reveal any significant safety concerns. Exceptionally, Orion publishes information about a project in early clinical development stage in a stock exchange release, because in this case, the information is estimated to meet the definition of inside information due to ODM-111’s strategic importance. This does not affect Orion's current disclosure policy, according to which Orion publishes information on its R&D projects mainly in its interim reports and/or press releases, but, as a main rule, provides information on the results of clinical Phase III trials in separate stock exchange releases. Annuncio • Aug 09
Orion Oyj, Annual General Meeting, Apr 03, 2025 Orion Oyj, Annual General Meeting, Apr 03, 2025. Annuncio • Jul 17
Orion Announces Phase III Aranote Trial of Darolutamide in Combination with Androgen Deprivation Therapy in Men with Metastatic Hormone-Sensitive Prostate Cancer Meets Primary Endpoint Orion announced Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer meets primary endpoint. Orion and Bayer’s Phase III ARANOTE trial meets primary endpoint, significantly increasing radiological progression-free survival with darolutamide + androgen deprivation therapy compared to placebo plus ADT. Safety analysis shows darolutamide plus ADT to be comparable to placebo plus ADT, reconfirming the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials. Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in metastatic hormone-sensitive prostate cancer. Bayer plans to present the pivotal data at a forthcoming scientific congress and prepare for submission with health authorities globally to extend the indication of darolutamide. The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer, has met its primary endpoint of rPFS. Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer. Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease, and patients with metastatic hormone-sensitive prostate cancer Detailed results of the ARANOTE trial are planned to be presented at a forthcoming scientific congress. Bayer plans to submit the data from the study to relevant global health authorities to support expanded use of darolutamide in men with mHSPC. ARANOTE is part of a robust clinical development program investigating darolutamide across various stages of prostate cancer, which includes the Phase III ARASTEP trial evaluating darolutamide plus ADT versus ADT alone in hormone-sensitive high-risk biochemical recurrence prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. A total of 669 patients were randomized to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Annuncio • Jul 02
Orion Oyj Revises Earnings Guidance for the Year 2024 Orion Oyj revised earnings guidance for the year 2024. For the year, the company's Operating profit is estimated to be EUR 350 million to EUR 380 million compared with previous guidance of EUR 280 million to EUR 310 million. Net sales are estimated to be EUR 1,440 million to EUR 1,480 million compared with previous guidance of EUR 1,340 million to EUR 1,410 million. Annuncio • May 08
Orion Corporation Announces Change in Orion Group Executive Management Board as of 31 May 2025 Olli Huotari, Senior Vice President responsible for Corporate Functions organization (including, i.a., Communications, Compliance, Corporate Responsibility, Intellectual Property Rights, Legal Affairs and Public Affairs) of the Orion Group and Secretary to the Board of Directors of Orion Corporation, and a member of the Executive Management Board of the Orion Group has informed the company of his decision to leave Orion. Orion will start a recruiting process of the successor to Olli Huotari. In order to secure a proper transition of responsibilities to his successor, Orion and Huotari have agreed that Huotari will continue in his current positions at Orion (including the membership of the Executive Management Board of the Orion Group) until 31 May 2025, after which he will leave the company. Annuncio • Apr 28
Orion Oyj Revises Earnings Guidance for the Year 2024 Orion Oyj revised earnings guidance for the year 2024. For the year, the company's Operating profit is estimated to be EUR 280 million to EUR 310 million compared with previous guidance of EUR 270 million to EUR 310 million. Net sales are estimated to be EUR 1,340 million to EUR 1,410 million compared with previous guidance of EUR 1,340 million to EUR 1,410 million. Annuncio • Apr 27
Orion Corporation Announces Appointments to Nomination Committee Orion Corporation has appointed Annika Ekman, Petteri Karttunen, Minna Maasilta, Veli-Matti Mattila and Seppo Salonen as members of nomination committee and Hilpi Rautelin as chair of nomination committee. The Committee prepares and presents a recommendation to the Board of Directors for the proposal to the Annual General Meeting concerning the composition of the Board. Annuncio • Mar 22
Orion Corporation Announces Change in Executive Management Board, Effect as of 1 April 2024 Orion Corporation announced Change in Orion Group Executive Management Board: change in Orion's group-level functions. The following change will take place in Orion's group-level functions: the Corporate Strategy and Program Management (CSPMO) unit will become part of the Finance and Corporate Business Development unit. The change will strengthen the steering of the Group and create a more unified approach to support Orion's business operations. As a result of the change, SVP Virve Laitinen will step down from the Orion Executive Management Board and will report to the Chief Financial Officer of the Orion Group as a Head of CSPMO. The change will take effect as of 1 April 2024. Annuncio • Jan 23
Orion Oyj Announces CFO Changes René Lindell has been appointed Chief Financial Officer of Orion Group as of 1 May 2024. He will start already as of 1 April 2024 as Executive Advisor (until 30 April 2024) and member of the Group Executive Management Board and will report to President and CEO Liisa Hurme. Lindell currently holds the position of Chief Financial Officer at Rovio Entertainment Corporation. He holds a Master of Science in Economics and a Ph.D. in Engineering. The current Chief Financial Officer of Orion Group Jari Karlson has announced that he will step down from his position at Orion as of 30 April 2024 and that he will retire. René Lindell Born in 1976 Finnish Citizen. Education: M.Sc. in Economics (Finance), Hanken School of Economics, 2006 and Ph.D. in Tech (Engineering Physics), Aalto University, 2005. Career: Rovio Entertainment Corporation Chief Financial Officer since 2017 - Member of Rovio’s Leadership team since 2016 Chief Strategy Officer and Strategy and Business development officer, 2014–2017. Nokia Corporation - Strategy Director, 2011–2014. Boston Consulting Group - Management Consultant, 2006–2011. Aalto University - Researcher, Low Temperature Laboratory, 2001–2006. Annuncio • Nov 22
Orion Corporation Announces Phase 3 Clinical Trials with ODM-208 (MK-5684) posted to ClinicalTrials.gov Database Orion Corporation announced two new Phase 3 clinical trials to evaluate the safety and efficacy of ODM-208 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) have been posted to the ClinicalTrials.gov website. The studies are not yet recruiting patients. Phase 3 Clinical Trials with ODM-208 (MK-5684) posted to ClinicalTrials.gov database. ODM-208 (or MK-5684) is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. ODM-208 is being developed through a collaboration with MSD (tradename of Merck & Co. Inc. Rahway NJ USA). Annuncio • Nov 21
Orion Corporation Receives Fda Approval for Bonqat (Pregabalin Oral Solution) Orion Corporation announced that the U.S. Food and Drug Administration (FDA) has granted approval of Bonqat®? (pregabalin oral solution) for alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. Pregabalin is a new active substance for veterinary use and it acts in the central nervous system by reducing the release of various neurotransmitters (glutamate and monoaminergic neurotransmitters), resulting in an anxiolytic effect. Orion's long-standing strategic partner, Zoetis, has the exclusive right to market and sell Bonqat in the United States. Bonqat is anticipated to be available in the U.S. by mid-2024. Annuncio • Aug 23
Orion Group Appoints Julia Macharey as Senior Vice President, People & Cultur Orion Group appointed Julia Macharey as Senior Vice President, People & Culture. Ms. Julia Macharey has been appointed Senior Vice President of Orion Group’s new People & Culture group-level function and member of the Executive Management Board of Orion Group as of February 1st 2024. She will report to President & CEO Liisa Hurme. She currently holds the position of Senior Vice President, Human Resources and Operational Development at Valmet and is a member of the Valmet Executive Team. Julia Macharey holds a Master of Science degree in Economics and a Bachelor of Arts degree. The new People & Culture function will focus on developing Orion’s professionals, capabilities and company culture and supporting growth, and Human Resources will be at the heart of this new group-level function as of February 1st. Julia Macharey Born 1977 Finnish citizen Education: Master of Science in Economics, University of Jyväskylä, 2000 Bachelor of Arts (Intercultural Communication), University of Jyväskylä, 1999 Career: Valmet 2019– Senior Vice President, Human Resources and Operational Development 2014–2019 Senior Vice President, Human Resources Metso Corporation, Metso Paper 2012–2013 Senior Vice President, Human Resources of Metso Pulp, Paper and Power segment Pöyry Plc 2007–2012 Vice President, Human Resources of Industry Business Group. Nokia Corporation 2006–2007 Senior Manager, Business HR of Manufacturing Solutions 2004–2006 Senior Manager, Business HR of Sourcing and Procurement SCA Hygiene Products Ltdand GmbH 2000–2004 Human Resources Manager and various HR management responsibilities. Annuncio • Jan 28
Orion Oyj Announces Positive CHMP Opinion for Darolutamide in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The final decision from the European Commission on the marketing authorisation is expected in the coming months. Darolutamide is already approved in its second indication, mHSPC, in a number of markets including the U.S. Filings in other regions are underway or planned by Orion’s collaboration partner Bayer. Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC. Prostate cancer is the most commonly diagnosed cancer in men in almost all northern and western European countries.1 Only 30% of men with mHSPC will survive five years or more after diagnosis.2 Most men with mHSPC eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited long-term survival. Darolutamide is developed jointly by Orion and Bayer. Bayer is responsible for global commercialisation, with co-promotion from Bayer and Orion in certain European markets, e.g. France, Germany, Italy, Spain, the UK, Scandinavia and Finland. 
