Orion Corporation (Orion Oyj)
Globally operating Finnish pharmaceutical company established in 1917, developing, manufacturing and marketing human and veterinary pharmaceuticals and active pharmaceutical ingredients; all manufacturing sites and the majority of R&D units are located in Finland. Listed on Nasdaq Helsinki with a dual share structure (ORNAV/ORNBV).
Clinical Trials
53
37 active
Approvals
94
Total approvals
Agencies
6
Regulatory bodies
Founded
1917
Active, not recruiting
37
69.8%
Completed
6
11.3%
Recruiting
10
18.9%
- Shilpa Biologicals and Finland-based Orion Corporation signed a co-development and exclusive supply agreement for an intravenous nivolumab biosimilar targeting the European market. - The partnership targets a European market opportunity of approximately USD 4.1 billion, based on IQVIA/IMS data showing nivolumab sales in 2025. - Shilpa will lead product development and serve as exclusive long-term manufacturer from its EU-GMP-compliant biologics facility in Dharwad, India. - Orion will hold exclusive rights to register, market, distribute, and sell the product across Europe as the Marketing Authorization holder.
- The U.S. Food and Drug Administration approved Tessie (tasipimidine) oral solution on May 6, 2026, marking the first veterinary approval for this Orion proprietary molecule in the United States. - Tasipimidine acts in the central nervous system by blocking the startle reflex to counteract arousal, providing a novel mechanism for treating noise aversion and separation anxiety in dogs. - Zoetis will exclusively market and sell Tessie in the United States starting mid-2027, expanding their behavioral product portfolio alongside existing treatments Sileo and Bonqat. - The approval represents a significant advancement in veterinary behavioral medicine, addressing clearly identified clinical needs in companion animal care.
- Orion Pharma's investigational drug ODM-212 has received Orphan Drug Designation from the US FDA for treating mesothelioma, a rare and difficult-to-treat cancer affecting fewer than 200,000 people in the US. - ODM-212 is an oral small-molecule pan-TEAD inhibitor currently being tested in a Phase 2 clinical study called TEADES for patients with malignant pleural mesothelioma and other solid tumors with Hippo pathway dysfunction. - The orphan drug designation qualifies Orion Pharma for regulatory incentives including tax credits, exemption from user fees, and eligibility for seven years of market exclusivity following approval. - The drug targets the Hippo signaling pathway by blocking TEAD transcription factors and disrupting protein interactions essential for tumor growth and therapy resistance.
- Orion Corporation has appointed Berkeley Vincent as Executive Vice President, Innovative Medicines, effective April 8, 2026, as part of a strategic leadership restructuring. - The appointment reflects the company's organizational evolution to split the previously combined R&D and Innovative Medicines role into two dedicated positions to strengthen global commercialization focus. - Vincent brings over 20 years of pharmaceutical industry experience from Johnson & Johnson, including roles as President of J&J Canada and Global Commercial Leader for IMBRUVICA. - The leadership change aims to enhance Orion's commercialization readiness as its innovative medicines pipeline continues to grow and mature.
- The Chinese National Medical Products Administration approved darolutamide (Nubeqa) in combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer patients. - The Phase III ARANOTE trial demonstrated that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT. - This approval provides Chinese physicians with greater treatment flexibility, allowing darolutamide use with or without chemotherapy for mHSPC patients. - Prostate cancer incidence in China is expected to reach 315,310 new cases and 81,540 deaths by 2030, highlighting the urgent need for effective treatments.
- Orion Corporation estimates that annual Nubeqa net sales recorded by the company have the potential to exceed €1 billion in the future, based on scenario planning with partner Bayer. - The Finnish pharmaceutical company projects 2026 net sales of €1.9-2.1 billion and operating profit of €550-750 million, with Nubeqa as the primary growth driver. - Nubeqa has become Orion's largest product by far, with net sales expected to continue growing strongly in 2026 through tablet sales to Bayer and royalty payments. - The sales potential remains subject to various changing conditions including regulatory environment, market dynamics, and product indications.
- Orion Corporation has obtained an exclusive commercial license to a monoclonal antibody from Abzena that targets a cancer with high clinical unmet need, strengthening Orion's oncology-focused R&D pipeline. - The antibody was developed using Abzena's proprietary Composite Human Antibody (CHAb™) technology and screened for functionality, safety, and manufacturability to minimize downstream development risks. - Abzena utilized its integrated developability platform and AbZelectPRO™ cell line development platform to create a stable, productive manufacturing cell line for the antibody. - The partnership leverages Abzena's over 20 years of monoclonal antibody experience and manufacturing capabilities up to 2,000 liters in scale across facilities in the UK and US.
- Orion Corporation announced that ODM-105 (tasipimidine) failed to meet primary endpoints in the Phase 2 UNITAS study for insomnia treatment, showing no significant improvement over placebo. - The company has discontinued its insomnia drug program and is shifting focus toward oncology research and development, including progress on darolutamide and a new monoclonal antibody licensing deal. - Despite the clinical setback, Orion maintained its full-year guidance and reported regulatory approvals for darolutamide in both Europe and the US. - The Phase 2 failure represents a challenge for Orion's pipeline momentum in a commercially important therapeutic area, potentially increasing R&D execution risks.
- Orion Corporation announced that ODM-105 (tasipimidine) failed to meet primary endpoints in the Phase 2 UNITAS study, showing no significant improvement in insomnia symptoms compared to placebo. - The randomized, triple-blind, placebo-controlled trial enrolled 153 adult patients with insomnia disorder and measured wake after sleep onset and latency to persistent sleep via polysomnography. - Despite the efficacy failure, ODM-105 demonstrated a favorable safety profile and was generally well tolerated throughout the study. - The company will discontinue development of ODM-105 for insomnia and redirect resources toward advancing other assets in their research and clinical pipeline.
- The European Patent Office has issued an intention to grant Tenax Therapeutics patent protection for levosimendan use in pulmonary hypertension with heart failure and preserved ejection fraction through December 2040. - The patent covers TNX-103 oral levosimendan and other formulations across multiple administration routes, strengthening Tenax's intellectual property portfolio for this first-in-disease drug candidate. - This European protection comes as Tenax prepares to initiate its second Phase 3 registrational study LEVEL-2, which will recruit patients across Europe this year. - The patent provides commercial protection in a European market where patient prevalence estimates approximate those in North America for this condition with no approved treatments.
