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) generates a steady stream of news related to pharmaceutical development, drug delivery technology and commercial progress. Company announcements emphasize its proprietary AmorphOX powder-based platform, clinical studies of intranasal rescue medications, and collaborations that extend its technology to new therapeutic areas.
Readers of this news feed can follow updates on Orexo’s work in opioid use disorder treatments in the U.S. market, as well as development projects such as OX124, a high-dose naloxone rescue medication for opioid overdose. Interim reports provide context on revenues, cash flow, and the performance of the U.S. Commercial segment, alongside commentary from management on business development and regulatory interactions.
A significant portion of Orexo’s recent news focuses on the AmorphOX platform and its application to intranasal formulations. This includes clinical and preclinical results for OX640, a nasal epinephrine powder product for severe allergic reactions including anaphylaxis, and preclinical data on powder-based intranasal semaglutide formulations. Company releases describe pharmacokinetic and pharmacodynamic findings, such as absorption profiles, plasma levels and effects on blood pressure and heart rate.
Another recurring news theme is collaboration on nasal powder vaccines. Orexo reports on its partnership with Abera Bioscience to combine AmorphOX with a vaccine platform for mucosal vaccines, including intranasal influenza vaccine candidates. Updates cover proof-of-concept immune response data and the potential implications for vaccine stability and administration.
Investors and observers can also track corporate governance items, such as the composition of the nomination committee for the annual general meeting, and participation in healthcare conferences. Bookmarking this page allows users to monitor Orexo’s clinical milestones, technology developments and financial disclosures as they are released.
On April 27, 2022, Orexo AB (OTCQX: ORXOY) announced that its partner Gesynta Pharma received Orphan Drug Designation from the FDA for OX-MPI (GS-248), targeting systemic sclerosis, a rare autoimmune disease. This designation provides up to seven years of market exclusivity and financial advantages for drug development. OX-MPI (GS-248) is currently undergoing a Phase 2 clinical trial, with results expected later in 2022. Orexo is entitled to a tiered share of future revenues from the drug, enhancing its revenue potential.
The annual general meeting of Orexo AB on April 21, 2022, confirmed eight board members, re-elected James Noble as chairman, and Ernst & Young as auditor. Total board fees are SEK 3,550,000, with additional fees for independent members. Guidelines for management remuneration were approved, and there will be no dividend for 2021. The meeting authorized new share issues and share repurchases, aimed at enhancing capital efficiency. Two long-term incentive programs for employees were established, mirroring previous years' structures.
Orexo has released its Annual Report for 2021, highlighting significant operational advancements. The report indicates that the company is on track with its rescue medication OX124, expected to launch in late 2023 if approved. Despite challenges in reimbursement for digital therapies, Orexo established important collaborations with healthcare providers. Total net sales for 2021 reached SEK 565 million, and the company employs 121 people. Orexo is listed on Nasdaq Stockholm Mid Cap (ORX) and OTCQX (ORXOY) in the US.
Orexo AB has convened its annual general meeting on April 21, 2022, at its Uppsala facility. Shareholders must register by April 11, 2022, to attend. The agenda includes the election of board members, presentation of annual reports, and resolutions on management remuneration guidelines. The board proposes no dividend for 2021, with profits carried forward. Key proposals involve board fees totaling SEK 3,550,000 and an additional fee for independent members linked to share acquisition. James Noble is proposed for re-election as chairman, with Ernst & Young as auditor.
Orexo AB announces the appointment of Fredrik Järrsten as the new Chief Financial Officer (CFO), effective by early September 2022. He succeeds Joseph DeFeo, who has served for four years and will assist during the transition. Järrsten brings extensive experience from several life science companies, enhancing Orexo's capabilities for further development and expansion, particularly in digital therapeutics. The company reported total net sales of SEK 565 million in 2021, focusing on improving pharmaceuticals for substance use disorders.
Orexo AB announced that its product ZUBSOLV® (buprenorphine and naloxone) will be added to the New York Medicaid MAT formulary as a preferred product effective March 22, 2022. This change increases ZUBSOLV®'s unrestricted access in the public segment by 6 percentage points to 48% in the U.S., up from 34% at the end of 2020. ZUBSOLV® has historically had a minimal presence in New York's Medicaid segment, which has a gross sales value of nearly USD 180 million. The improved access is expected to boost Orexo's growth opportunities and strengthen its market position amongst Medicaid patients.
Orexo reported Q4 2021 net revenues of SEK 144.0 m, down from SEK 159.2 m in Q4 2020. The company faced net earnings of SEK -66.0 m and EBITDA of SEK -48.5 m. The US Pharma segment (ZUBSOLV®) generated SEK 133.6 m in net revenues, showing a decline from last year. Operating cash flow was SEK -80.6 m, while cash reserves remained stable at SEK 504.1 m. Positive developments included a favorable outcome for the OX124 pivotal trial and the initiation of a new project, OX640, for a nasal adrenaline rescue medication.
Orexo AB (OTCQX: ORXOY) has announced the initiation of OX640, a nasal adrenaline product aimed at emergency treatment of allergic reactions, a market valued over USD 2 billion. This product leverages Orexo's proprietary amorphOX platform, promising stability and convenience compared to current auto-injectors. The FDA has been consulted regarding the development plan, with an exploratory clinical study expected in late 2022 to finalize timelines. Orexo aims to explore partnerships in development and commercialization to bring OX640 to market.
Orexo AB (publ.) has unveiled its novel drug delivery platform, amorphOXTM, which enhances the stability of amorphous drug compositions. This innovative powder technology allows for rapid drug dissolution and is suitable for various administration routes, such as nasal and sublingual. The platform has demonstrated effectiveness in in vivo studies and offers a competitive advantage for Orexo's first product, OX124, an overdose rescue medication. Several new patent applications have been filed to protect amorphOXTM until 2042.
Orexo AB (OTCQX:ORXOY) has successfully completed the pivotal trial for its lead drug candidate OX124, demonstrating faster absorption of naloxone compared to traditional methods. The trial met its primary endpoints, allowing the company to anticipate filing a New Drug Application (NDA) with the FDA in H2 2022, followed by a potential US launch in H2 2023. OX124 aims to address the rising opioid overdose crisis, which has seen over 96,000 overdose deaths in the US, predominantly from synthetic opioids. Orexo's innovative formulation positions it well in a growing market.