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 reported its Q1 2023 financial results, with net revenues of SEK 158.8 million, slightly down from SEK 159.4 million in Q1 2022. The company experienced a significant EBITDA decline, reporting SEK -41.1 million compared to SEK 2.8 million last year. Net earnings also saw a loss of SEK -63.9 million, worse than the previous SEK -23.6 million. Despite stable ZUBSOLV® sales in both SEK and USD, operating expenses surged by 30.6%, totaling SEK 189.4 million. A New Drug Application for OX124 has been submitted to the FDA, but challenges in the packaging line require a resubmission planned for Q3 2023. Cash flow from operations stood at SEK -61.6 million, with cash reserves down to SEK 278.9 million.
On April 18, 2023, Orexo AB held its annual general meeting, confirming the board of directors with eight members, including James Noble as chairman. The board received a fee of SEK 3,550,000, and an additional SEK 1,050,000 for independent members, contingent upon acquiring shares in Orexo. The meeting approved the financial statement for 2022, with no dividends declared. Authorization was granted for share issuances and repurchases up to 20% and 10% of shares, respectively. Two new long-term incentive programs (LTIP 2023 and LTIP Stay-on 2023) were adopted for selected employees. Orexo reported total net sales of SEK 624 million for 2022, primarily from its product ZUBSOLV® for opioid use disorder.
Orexo AB announces a delay in the US launch of OX124, a high-dose rescue medication for opioid overdose, pushing the anticipated date to late 2024 from early 2024. This shift is attributed to unforeseen technical issues with the secondary packaging process, requiring a resubmission of the New Drug Application (NDA) to the FDA. Despite the delay, the FDA has indicated that the request for resubmission is solely due to the packaging issues and not other concerns. Orexo aims to resubmit the NDA by Q3 2023, with hopes for approval in the latter half of 2024.
Nikolaj Sørensen, CEO, expressed disappointment over the delay but emphasized confidence in resolving the packaging issues.
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