Outlook Therapeutics received a third complete response letter (CRL) from the U.S. FDA for its bevacizumab biosimilar ONS‑5010 for wet age‑related macular degeneration, prompting a sharp share price decline and investor concern about the company’s runway. Analysts warned that regulatory setbacks and recent European approvals for competing products shrink the company’s commercial opportunity. The CRL raises questions about Outlook’s ability to resolve deficiencies and fund further development. Market commentators noted that repeated regulatory refusals materially increase the risk of insolvency or forced asset sales unless new capital or partners emerge.