Outlook Therapeutics shares surge 14.75% after-hours as FDA accepts BLA for ONS-5010 with December 31, 2025 PDUFA date.

Outlook Therapeutics surged 14.75% in after-hours trading following the announcement of Laura Cantrell’s appointment as Vice President of Corporate Strategy and Business Development on January 7, 2026. Cantrell, a seasoned biotech executive with experience in business development and global partnerships, is expected to lead strategic initiatives to advance the company’s programs and explore licensing opportunities. This move comes amid ongoing regulatory challenges, including a third FDA rejection of ONS-5010 in December 2025 and a subsequent stock price collapse of over 60%. The appointment of Cantrell signals a strategic pivot to strengthen the company’s growth prospects and address liquidity concerns, offering investors a potential catalyst amid prolonged regulatory uncertainty.