Welcome to our dedicated page for Orexo Ab news (Ticker: ORXOY), a resource for investors and traders seeking the latest updates and insights on Orexo Ab stock.
Orexo AB (ORXOY) is a Swedish pharmaceutical innovator specializing in advanced drug-delivery systems and treatments for opioid use disorder, overdose reversal, and allergic emergencies. This page aggregates official company announcements, clinical trial updates, and strategic financial developments.
Investors and industry professionals will find timely updates on Orexo’s proprietary AmorphOX technology, regulatory milestones, and social bond issuances. Key content includes earnings reports, partnership announcements, patent extensions, and progress on high-priority therapies like OX124 (naloxone) and OX640 (epinephrine).
All updates are sourced directly from Orexo’s communications and verified third-party coverage. Bookmark this page to monitor the company’s progress in addressing critical healthcare challenges through pharmaceutical innovation and sustainable financing strategies.
Orexo AB (STO: ORX) (OTCQX: ORXOY) has received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication for opioid overdose. The FDA requires an additional Human Factors (HF) study and more technical data on the final commercial product. No additional clinical or non-clinical studies are needed.
Orexo has already completed a new HF study successfully. The company will work quickly to address the unexpected request for additional technical data. The NDA resubmission review period will be up to six months. OX124 aims to meet the growing need for more powerful medications to reverse overdoses caused by synthetic opioids like fentanyl, which account for 92% of all fatal opioid overdoses.
Orexo AB has achieved a Gold Sustainability Rating from EcoVadis, placing it in the top 5% of the 70,000 businesses reviewed annually. This recognition is based on the company's sustainability efforts in Sweden, covering headquarters functions, R&D, Regulatory Affairs, Quality & SHE, and Supply Chain. The rating highlights Orexo's success in environmental, labor and human rights, ethics, and sustainable procurement areas. CEO Nikolaj Sørensen emphasized that the company will continue to set ambitious sustainability goals to benefit patients, investors, the company, and society.
Orexo will release its Q2 2024 Interim Report on July 17, 2024, at 8 am CET. A presentation for analysts, investors, and media will follow at 2 pm the same day, featuring CEO Nikolaj Sørensen and CFO Fredrik Järrsten. The presentation will cover the latest developments and include a Q&A session. Interested parties can attend either via teleconference or webcast, with registration details and relevant links provided in the press release. Presentation materials will be available on Orexo's website under the Investors/Reports, Presentations section prior to the event.
Orexo AB (ORXOY) has successfully issued senior secured callable floating rate social bonds worth SEK 500 million with a tenor of four years. The company has applied for admission to trading of the bonds on Nasdaq Stockholm after having the listing prospectus approved by the Swedish Financial Supervisory Authority. The estimated first day of trading is around May 14, 2024.
Orexo's Q1 2024 interim report shows positive EBITDA growth, with total net revenues of SEK 139.3 million. The company reported a net earnings improvement, with key data on clinical studies and product stability. Orexo also secured a social bond for refinancing and obtained a new patent. CEO highlights financial stability and R&D progress, aiming for product launch in late 2024 or early 2025.
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