Reported Earnings • Jul 19
Second quarter 2026 earnings released: EPS: €1.00 (vs €0.59 in 2Q 2025) Second quarter 2026 results: EPS: €1.00 (up from €0.59 in 2Q 2025). Revenue: €521.6m (up 25% from 2Q 2025). Net income: €140.2m (up 70% from 2Q 2025). Profit margin: 27% (up from 20% in 2Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 8.2% p.a. on average during the next 3 years, compared to a 4.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 33% per year whereas the company’s share price has increased by 30% per year. New Risk • Jun 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Italian stocks, typically moving 6.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (30% accrual ratio). Minor Risks Dividend is not well covered by cash flows (144% cash payout ratio). Share price has been volatile over the past 3 months (6.5% average weekly change). Ankündigung • 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. Declared Dividend • May 20
Dividend of €0.90 announced Shareholders will receive a dividend of €0.90. Ex-date: 19th October 2026 Payment date: 21st October 2026 Dividend yield will be 2.6%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is covered by earnings (48% earnings payout ratio) but not covered by cash flows (144% cash payout ratio). The dividend has increased by an average of 3.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 28% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Reported Earnings • Apr 24
First quarter 2026 earnings released: EPS: €0.64 (vs €0.44 in 1Q 2025) First quarter 2026 results: EPS: €0.64 (up from €0.44 in 1Q 2025). Revenue: €417.7m (up 18% from 1Q 2025). Net income: €90.4m (up 48% from 1Q 2025). Profit margin: 22% (up from 17% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 7.5% p.a. on average during the next 3 years, compared to a 4.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has only increased by 18% per year, which means it is significantly lagging earnings growth. Ankündigung • 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. Declared Dividend • Apr 02
Dividend of €0.90 announced Shareholders will receive a dividend of €0.90. Ex-date: 19th October 2026 Payment date: 21st October 2026 Dividend yield will be 2.5%, which is about the same as the industry average. Sustainability & Growth Dividend is covered by earnings (51% earnings payout ratio) but not covered by cash flows (116% cash payout ratio). The dividend has increased by an average of 3.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 27% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Ankündigung • 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. Declared Dividend • Feb 16
Final dividend of €0.90 announced Shareholders will receive a dividend of €0.90. Ex-date: 25th March 2026 Payment date: 27th March 2026 Dividend yield will be 2.5%, which is about the same as the industry average. Sustainability & Growth Dividend is covered by earnings (51% earnings payout ratio) but not covered by cash flows (116% cash payout ratio). The dividend has increased by an average of 3.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 29% over the next 3 years, which should provide support to the dividend and adequate earnings cover. New Risk • Feb 14
New major risk - Earnings quality The company has a high level of non-cash earnings. Accrual ratio: 22% This is considered a major risk. Non-cash earnings can arise from many different things. However, if a company consistently has a high level of non-cash earnings, it may be a sign that they are recognizing revenue from customers before the full value of the sales are received as cash or they are not depreciating the value of their assets appropriately. These are practices that inflate earnings, while not providing a similar increase to cash flows. Companies in some select industries naturally have a high level of non-cash earnings and it is not a major concern. However, in the worst case scenario it can be an early sign of performance manipulation by management. Currently, the following risks have been identified for the company: Major Risk High level of non-cash earnings (22% accrual ratio). Minor Risks Dividend is not well covered by cash flows (116% cash payout ratio). Share price has been volatile over the past 3 months (5.5% average weekly change). Reported Earnings • Feb 14
Full year 2025 earnings released: EPS: €3.56 (vs €2.35 in FY 2024) Full year 2025 results: EPS: €3.56 (up from €2.35 in FY 2024). Revenue: €1.89b (up 23% from FY 2024). Net income: €500.3m (up 52% from FY 2024). Profit margin: 27% (up from 21% in FY 2024). The increase in margin was driven by higher revenue. Products in clinical trials Phase II: 8 Phase III: 6 Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 4.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 14% per year whereas the company’s share price has increased by 15% per year. New Risk • Jan 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Italian stocks, typically moving 5.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Dividend is not well covered by cash flows (105% cash payout ratio). Share price has been volatile over the past 3 months (5.3% average weekly change). Ankündigung • 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. Board Change • Jan 09
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • 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. Board Change • Dec 19
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • 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. Reported Earnings • Oct 30
Third quarter 2025 earnings released: EPS: €0.68 (vs €1.14 in 3Q 2024) Third quarter 2025 results: EPS: €0.68 (down from €1.14 in 3Q 2024). Revenue: €423.2m (down 10% from 3Q 2024). Net income: €96.0m (down 40% from 3Q 2024). Profit margin: 23% (down from 34% in 3Q 2024). The decrease in margin was primarily driven by lower revenue. Revenue is forecast to grow 9.7% p.a. on average during the next 3 years, compared to a 5.2% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 10% per year, which means it is tracking significantly ahead of earnings growth. Board Change • Oct 30
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • 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. New Risk • Oct 10
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: €471k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Minor Risks Dividend is not well covered by cash flows (106% cash payout ratio). Significant insider selling over the past 3 months (€471k sold). Upcoming Dividend • Oct 10
Upcoming dividend of €0.82 per share Eligible shareholders must have bought the stock before 15 October 2025. Payment date: 23 October 2025. Payout ratio is a comfortable 61% but the company is paying out more than the cash it is generating. Trailing yield: 2.4%. Lower than top quartile of Italian dividend payers (4.9%). Lower than average of industry peers (2.7%). Ankündigung • 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. Board Change • Sep 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Board Change • Jun 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 4 highly experienced directors. Director Henrik Stenqvist was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Aug 08
Orion Oyj to Report Q1, 2025 Results on Apr 23, 2025 Orion Oyj announced that they will report Q1, 2025 results on Apr 23, 2025 
