Outlook Therapeutics’ shares tumbled 67% over the past week after the U.S. Food and Drug Administration issued its third Complete Response Letter for the company’s biologics license application (BLA) for ONS-5010, its investigational ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD). The regulator once again requested confirmatory clinical data to support the product’s safety and efficacy, extending the review timeline by an estimated 12 to 18 months. Investors reacted sharply to the news, erasing roughly two-thirds of the company’s market capitalization in five trading sessions and prompting several analysts to revise their risk assessments downward. With ONS-5010 still unapproved in the U.S., Outlook’s near-term revenue prospects for its lead asset are now uncertain, intensifying pressure on the balance sheet as the firm approaches a reported cash runway through mid-2026.

Outlook Therapeutics has named Laura Cantrell as Vice President of Corporate Strategy and Business Development, effective immediately. Cantrell brings over 20 years of global biotechnology experience spanning corporate strategy, business development and portfolio leadership, most recently supporting Medivation’s $14 billion acquisition by Pfizer and steering commercial assessments for oncology asset deals. In her new role, she will lead the company’s strategic partnerships, licensing negotiations and M&A initiatives, with a mandate to secure high-value collaborations and extend the commercial footprint of LYTENAVA™ in Europe and beyond. Chief Executive Officer Bob Jahr noted that Cantrell’s track record in deal execution and portfolio optimization will be critical as Outlook seeks to shore up finances, pursue alternative regulatory pathways and prepare for a potential U.S. launch of its first ophthalmic bevacizumab product.