Outlook Therapeutics received a third complete response letter (CRL) from the U.S. FDA for ONS‑5010, its bevacizumab biosimilar formulation for wet age‑related macular degeneration, prompting a steep share decline. The company reported the regulatory setback on Jan. 2, 2026, with the stock plunging roughly 62% intraday, according to market notices. The CRL represents a critical regulatory barrier for Outlook’s flagship program and raises questions about resubmission timelines, required chemistry/manufacturing controls, and potential additional clinical data demands. Investors and peers will watch for the company’s corrective plan and engagement with FDA.