Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s world-class drug delivery platform, amorphOX®. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay.
Q3 2023 highlights› Total net revenues of SEK 156.1 m (161.0)› EBITDA of SEK -9.5 m (-32.4), EBITDA excluding costs for legal processes and external non-repeating clinical trials, SEK 13.3 m (14.3) › Net earnings of SEK -33.3 m (-26.5)› US Pharma segment (ZUBSOLV® US) net revenues of SEK 140.4 m (150.1), in local currency USD 13.0 m (14.2), US Pharma EBIT of SEK 62.3 m (70.2)› Cash flow from operating activities of SEK -21.9 m (-60.7), cash and invested funds of SEK 184.2 m (443.9)› Earnings
Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), announces that Robin Evers, Senior Vice President, Head of Global Regulatory Affairs & Global Safety, Medical Writing and R&D Quality, at Novo Nordisk A/S has become a member of the company´s Board of Directors. Robin Evers replaces Henrik Kjaer Hansen, who has announced he will resign after having represented Orexo´s largest shareholder, Novo Holdings A/S, since 2018. Henrik Kjaer Hansen will continue to work closely with Orexo as chairman of Orexo´s