Orion Oyj B — MarketDX

Biotech & Genomic Medicine▼

Orion partner Tenax Therapeutics' Phase 3 LEVEL trial of oral levosimendan misses primary endpoint

Orion Corporation's license partner Tenax Therapeutics announced that the Phase 3 LEVEL trial of oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo. The key secondary endpoint of improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score was also not met. Prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. Oral levosimendan was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration to discuss revisions to the ongoing registrational development of levosimendan for PH-HFpEF, and to seek parallel scientific consultation from the European Medicines Agency.

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Orion Corporation converts 45,611 A shares into B shares

Orion Corporation has converted 45,611 A shares into an equal number of B shares, with the conversion entered into the Trade Register on 15 July 2026. Following the conversion, the total number of shares stands at 141,134,278, comprising 31,373,179 A shares and 109,761,099 B shares, and the total number of votes is 737,224,679. The conversion was carried out in accordance with Section 3 of the company's Articles of Association.

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Biotech & Genomic Medicine▲

Orion Pharma ja Shilpa Medicare sopimukseen nivolumabi-biosimilaarituotteen oikeuksista Euroopassa

Orion Pharma ja Shilpa Biologicals Private Limited, Shilpa Medicare Limitedin kokonaan omistama tytäryhtiö, ovat tehneet sopimuksen suonensisäisen nivolumabi-biosimilaarituotteen kaupallistamisesta Euroopassa. Sopimuksen mukaan Orion saa yksinoikeuden tuotteen jakeluun, markkinointiin ja myyntiin Euroopassa, ja Shilpa toimittaa tuotteen Orionille. Shilpa on oikeutettu saamaan Orionilta tiettyjä tuotteen kehitykseen ja hyväksyntään liittyviä etappimaksuja. Nivolumabi on immuunivasteen vapauttaja, jota käytetään useiden syöpäsairauksien hoidossa, ja Shilpa kehittää parhaillaan suonensisäistä nivolumabi-biosimilaaria. Orionin Generics and Consumer Health -yksikön johtaja Satu Ahomäki kuvaili sopimusta askeleeksi eteenpäin yhtiön pyrkimyksissä laajentaa toimintaansa Manner-Euroopan sairaalasegmentissä.

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Biotech & Genomic Medicine ▼

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Biotech & Genomic Medicine▲

Orion Pharma signs agreement with Shilpa Medicare for nivolumab biosimilar in Europe

Orion Pharma and Shilpa Biologicals, a subsidiary of Shilpa Medicare, have entered into an agreement to commercialise an intravenous nivolumab biosimilar in Europe. Under the deal, Orion gains exclusive rights to distribute, market and sell the product in Europe, while Shilpa will supply it and receive certain development and regulatory milestone payments. Nivolumab is an immune checkpoint inhibitor used to treat various cancers, and Shilpa's biosimilar is currently under development. Orion's EVP of Generics and Consumer Health, Satu Ahomäki, said the agreement strengthens the company's hospital segment in Continental Europe and advances its strategy to provide affordable quality medicines. Shilpa Medicare's Managing Director, Vishnukant Bhutada, called the extension of the partnership into immuno-oncology a defining moment that reflects trust in the company's quality and ability to deliver complex biologics at scale.

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Orion declares $0.0207 quarterly dividend

Orion has declared a quarterly dividend of $0.0207 per share, in line with the previous payout. The dividend is payable on October 7 to shareholders of record as of July 6, with the ex-dividend date also set for July 6. The forward yield stands at 1.15%.

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Biotech & Genomic Medicine▲2

Orion Pharma's ODM-212 gets EU orphan designation for malignant mesothelioma

Orion Pharma's investigational drug ODM-212 has received Orphan Designation from the European Commission for the treatment of malignant mesothelioma. The designation, based on a recommendation from the European Medicines Agency's Committee for Orphan Medicinal Products, qualifies Orion for incentives including protocol assistance, fee reductions, and a 10-year market exclusivity period upon approval. ODM-212 is an oral small-molecule pan-TEAD inhibitor currently in a Phase 2 global trial for malignant pleural mesothelioma and other solid tumors with Hippo pathway dysfunction. The US FDA had previously granted Orphan Drug Designation to ODM-212 for mesothelioma.

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Biotech & Genomic Medicine

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BlackRock's stake in Orion Corporation rises above 5%

BlackRock, Inc. and its funds have increased their total holding in Orion Corporation to 5.11% of shares, crossing the 5% disclosure threshold on 17 June 2026. The position comprises 5.01% held directly as shares and voting rights, plus an additional 0.09% through financial instruments including American Depositary Receipts, securities lending, and contracts for difference. Orion Corporation's total number of shares is 141,134,278, with 738,091,288 voting rights. The previous notification had shown a combined holding of 5.01%.

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