Outlook Therapeutics Shares Plummet Following HC Wainwright Downgrade.

Outlook Therapeutics' shares have fallen after HC Wainwright downgraded the company. The biopharmaceutical company is focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-gamma) for retinal indications. The company is advancing ONS-5010/LYTENAVA (bevacizumab-vikg) for wet age-related macular degeneration, diabetic macular edema, and branch retinal vein occlusion.

Outlook Therapeutics, Inc. (OTLK) saw its shares drop significantly after H.C. Wainwright downgraded the company's stock to "neutral" from "buy" and the U.S. FDA declined to approve the company's eye drug, ONS-5010. The FDA's decision, announced on August 28, 2025, came after the company submitted a biologics license application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).

The FDA issued a complete response letter (CRL) indicating that the application could not be approved in its current form due to a lack of substantial evidence of effectiveness. The FDA advised that confirmatory evidence of efficacy should be submitted to support the application for ONS-5010. The FDA also noted that the company's NORSE EIGHT trial did not meet its primary efficacy endpoint, while the NORSE TWO trial did meet its primary endpoint.

H.C. Wainwright, a brokerage firm, downgraded OTLK's stock and cited the FDA's decision as a key reason for the downgrade. The brokerage firm also noted that the company's cash position complicates matters, and it expects the company to raise additional capital to support operations. Additionally, the brokerage firm stated that sales in Europe and the UK are modest growth drivers, and stock dilution is expected regardless of FDA approval.

Outlook Therapeutics, however, remains optimistic and plans to meet with the FDA to address the deficiency identified in the CRL. The company also intends to continue its efforts to expand into additional markets in Europe. LYTENAVA™ (bevacizumab gamma), the subject of a centralized Marketing Authorization granted by the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD, has already been commercially available in Germany and the UK since June 2025.

Despite the setback, Outlook Therapeutics remains committed to providing patients with a safe and effective alternative to compounded Avastin manufactured in the United States. The company's focus is on enhancing the standard of care for bevacizumab for the treatment of retina diseases.

References:
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_L4N3UL0V4:0-outlook-falls-as-wainwright-downgrades-stock-after-us-fda-declines-to-approve-eye-drug/
[2] https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug