Outlook Therapeutics Shares Plummet After FDA Rejects Drug for Second Time

Outlook Therapeutics' shares plummeted 53% to an all-time low after the FDA rejected the company's proposed eye-disease drug for the second time. The FDA cited a lack of substantial evidence of effectiveness, as the company's study missed its primary efficacy endpoint. The company plans to request a meeting with the FDA to determine the best path forward.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) experienced a significant regulatory setback on August 28, 2025, when the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company's resubmitted biologics license application (BLA) for ONS-5010, a drug intended to treat wet age-related macular degeneration (wet AMD) [1]. The FDA cited a lack of substantial evidence of effectiveness, as the company's NORSE EIGHT trial failed to meet its primary efficacy endpoint.

The CRL identified only one deficiency, indicating that the FDA's concerns are focused on the lack of substantial evidence of effectiveness. Outlook Therapeutics plans to meet with the FDA to gain clarity on their requirements and address the identified deficiencies. The company remains committed to providing a safe and effective alternative to compounded Avastin manufactured in the United States [1].

Outlook Therapeutics has already made strides in the European market. LYTENAVA™ (bevacizumab gamma), the company's ophthalmic formulation of bevacizumab, received Marketing Authorization in the EU and UK for the treatment of wet AMD and became commercially available in Germany and the UK in June 2025. LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK [1].

The stock price of Outlook Therapeutics plummeted 53% to an all-time low following the FDA's rejection. The company plans to request a meeting with the FDA to determine the best path forward. The FDA's Complete Response Letter indicates that the resubmitted BLA for ONS-5010 cannot be approved in its current form, reflecting significant regulatory setbacks. The letter raises concerns about the product's viability and efficacy, potentially impacting the company's market position in the US for wet AMD treatments [1].

References:
[1] https://www.quiverquant.com/news/Outlook+Therapeutics+Receives+Complete+Response+Letter+from+FDA+for+ONS-5010+BLA+Resubmission