Outlook Therapeutics received a third complete response letter for its bevacizumab formulation ONS‑5010 to treat wet age‑related macular degeneration, triggering an almost 62% intraday stock collapse. The FDA action raises substantial uncertainty around the company’s ability to secure approval or financing in the near term. Analysts cited a narrowing window for funding and competitive alternatives as headwinds. For developers of ophthalmic biologics, the episode underscores regulatory risk in formulation and CMC packages and the market sensitivity of repeat CRLs for small cap biotechs.