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Orexo AB (ORXOY) reports developments for a Swedish pharmaceutical company whose U.S. security trades as ADRs on the OTCQX market. News centers on the company’s AmorphOX powder-based drug delivery technology, which is used to improve bioavailability and stability for small molecules, peptides and larger biomolecules, and on a diversified pipeline in clinical and preclinical development.
Recurring updates include R&D priorities following the U.S. Zubsolv divestment, organizational changes tied to product development, OX640 nasal epinephrine data for severe allergic reactions including anaphylaxis, intranasal formulation work with semaglutide, and collaborations for nasal powder vaccines. Company announcements also cover partner research, conference presentations and the parent company’s Nasdaq Stockholm listing alongside the ORXOY ADR program.
Orexo has released its Q3 2022 financial highlights, reporting total net revenues of SEK 161.0 million, up from SEK 145.9 million year-over-year. EBITDA improved to SEK -32.4 million compared to SEK -47.4 million previously. The US Pharma segment saw revenues of SEK 150.1 million. Cash flow from operations was SEK -60.7 million, with total cash and invested funds at SEK 443.9 million, down from SEK 588.1 million. A clinical study for OX640 was initiated, and positive data was announced thereafter.
Orexo AB (OTCQX: ORXOY) has announced the completion of participant enrollment in a pivotal study of its digital therapeutic, MODIA®, intended for treating opioid use disorder (OUD). This study involves 437 participants across 35 sites in the US and aims to evaluate MODIA® in combination with sublingual buprenorphine/naloxone against buprenorphine/naloxone alone. Orexo emphasizes its deep expertise in the OUD market, having worked extensively with their product, ZUBSOLV®, over the past nine years. The study's results are expected to support FDA clearance.
Orexo AB (OTCQX: ORXOY) has appointed Dr. Edward (Ed) Kim as the new Chief Medical Officer, succeeding Dr. Michael Sumner. Ed Kim, who has a strong background in psychiatry and over 16 years in the pharmaceutical industry, will lead US Medical Affairs and enhance collaboration with Orexo’s Swedish team. His focus will be on innovative treatments for substance use disorders and mental health. This leadership change highlights Orexo’s commitment to developing effective solutions in a critical therapeutic area.
Orexo has appointed a Nomination Committee ahead of its Annual General Meeting (AGM) scheduled for April 18, 2023. The committee includes Christian Salling, Claus Berner Møller, Patrik Walldov, and James Noble, representing approximately 38% of voting rights as of September 30, 2022. The committee will propose key governance decisions, including the Chairman of the Meeting and Board members' remuneration. Shareholders can submit proposals to the Nomination Committee until February 17, 2023. Orexo specializes in pharmaceuticals for substance use disorders, with notable sales of SEK 565 million in 2021.
Orexo announced positive results from its first human clinical study (OX640-001) for OX640, a nasal epinephrine rescue medication for allergic reactions. The study, involving 40 healthy volunteers, demonstrated that all four investigational formulations achieved clinically relevant plasma levels of epinephrine rapidly, outperforming the current standard. With a target market exceeding USD 2 billion and expected annual growth of 8-9%, Orexo plans to pursue partnerships for the further development and commercialization of OX640, leveraging its patented amorphOX® platform.
Orexo AB (OTCQX: ORXOY) has partnered with Trinity Health to enhance patient access to its digital therapeutics, vorvida® and deprexis®. The collaboration establishes a collaborative care model, educating over 50 healthcare professionals to integrate these therapies, which aim to assist patients dealing with depression and excessive drinking. Trinity Health serves over 200,000 people across North Dakota and Eastern Montana, addressing significant mental health and substance use issues in these regions. This partnership marks a significant step in expanding access to evidence-based psychosocial support.
Orexo AB (publ.) announced on September 1, 2022, that the European Patent Office has granted a patent for OX640, its nasal adrenaline rescue medication. The patent (EP 3 962 455 B1) protects OX640 in Europe until May 2041, supporting Orexo's position in ongoing discussions with potential partners. CEO Nikolaj Sørensen emphasized the product’s innovation and market potential, alongside strong clinical data expected later this year. Orexo aims to enhance its patent portfolio for OX640 across various territories.
Orexo AB (OTCQX: ORXOY) announced its participation in the Pareto Securities' 13th Annual Healthcare Conference on September 7-8, 2022, in Stockholm, Sweden. CEO Nikolaj Sørensen will present on September 7 at 2:30 pm CET, and he, along with new CFO Fredrik Järrsten, will be available for meetings. Orexo develops pharmaceuticals and digital therapies aimed at addressing substance use disorders, with its lead product ZUBSOLV® for opioid use disorder. The company reported total net sales of SEK 565 million in 2021.
Orexo's Q2 2022 report highlights significant financial improvement with total net revenues reaching SEK 147.8 million, up from SEK 142.8 million last year. The US Pharma segment, particularly ZUBSOLV®, generated net revenues of SEK 139.6 million. Despite net losses of SEK 35.8 million, earnings per share improved to -1.04 from -2.15. Cash flow from operations increased positively to SEK 14.5 million.
Orexo has secured a Veterans Affairs Federal Supply Schedule contract for its digital therapy deprexis®, effective late July 2022. This long-term contract expands access to nearly 15 million US citizens in federal healthcare systems, including the Veterans Affairs, Indian Health Service, and Department of Defense. Initial commercialization efforts are anticipated to begin late Q4 2022, with expanded usage expected throughout 2023. The contract will last until 2032.