Guggenheim downgrades Outlook Therapeutics to Neutral from Buy.

Guggenheim downgrades Outlook Therapeutics to Neutral from Buy.

Guggenheim Securities has downgraded Outlook Therapeutics, Inc. (OTLK) to Neutral from Buy, citing significant regulatory setbacks and market uncertainties. The move comes following the U.S. Food and Drug Administration (FDA) rejection of the company's ONS-5010/LYTENAVA (bevacizumab-vikg) drug, a treatment for wet age-related macular degeneration (wet AMD). The FDA cited a lack of substantial evidence of effectiveness, as the company's NORSE EIGHT trial failed to meet its primary efficacy endpoint [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 (CRL) indicates that the resubmitted Biologics License Application (BLA) for ONS-5010 cannot be approved in its current form, reflecting significant regulatory setbacks [2].

Despite the setback, Outlook Therapeutics has 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 [3]. The company remains committed to providing a safe and effective alternative to compounded Avastin for wet AMD treatment in the United States.

Guggenheim's downgrade reflects the market's concern over the drug's viability and efficacy, potentially impacting Outlook Therapeutics' market position in the US for wet AMD treatments. The company's ability to address the FDA's concerns and secure approval for ONS-5010 will be crucial in determining its future prospects.

References:
[1] https://www.ainvest.com/news/outlook-therapeutics-shares-plummet-fda-rejects-drug-time-2508/
[2] https://www.marketscreener.com/news/us-fda-declines-to-approve-outlook-therapeutics-drug-for-eye-condition-ce7c50dfde89fe21
[3] https://za.investing.com/news/stock-market-news/outlook-therapeutics-stock-falls-after-fda-rejects-wet-amd-drug-93CH-3858892