FDA Issues New Setback for Outlook Therapeutics’ LYTENAVA

Outlook Therapeutics ( (OTLK) ) has shared an update.

On December 31, 2025, Outlook Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter to its resubmitted biologics license application for ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration, stating it could not approve the application in its current form and again calling for additional confirmatory evidence of efficacy without specifying what form that evidence should take. The setback delays potential U.S. approval despite the company’s reliance on data from its NORSE clinical trial program, including the successful NORSE TWO pivotal study and the NORSE EIGHT non-inferiority trial, and shifts strategic emphasis toward exploring alternative regulatory pathways in the U.S. while expanding commercialization and partnership efforts in Europe and other regions, where LYTENAVA is already authorized and beginning to establish a foothold as a differentiated, on-label bevacizumab option for wet AMD patients.

The most recent analyst rating on (OTLK) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Outlook Therapeutics stock, see the OTLK Stock Forecast page.

Spark’s Take on OTLK Stock

According to Spark, TipRanks’ AI Analyst, OTLK is a Neutral.

The score is primarily held down by very weak financial performance (ongoing losses, negative equity, and heavy cash burn). Technicals provide moderate support (neutral momentum with price above key longer-term averages), and the BLA resubmission is a meaningful positive event, but valuation is constrained by loss-driven negative earnings and no dividend yield.

To see Spark’s full report on OTLK stock, click here.

More about Outlook Therapeutics

Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-vikg, bevacizumab gamma), an ophthalmic formulation of bevacizumab designed to enhance the standard of care for retinal diseases such as wet age-related macular degeneration (wet AMD). The company has already secured Marketing Authorizations from the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency for LYTENAVA for wet AMD and began commercial launches in Germany and the UK in June 2025, positioning it as the first and only authorized ophthalmic bevacizumab for wet AMD in those markets.

Average Trading Volume: 3,910,386

Technical Sentiment Signal: Sell

Current Market Cap: $101.3M

For an in-depth examination of OTLK stock, go to TipRanks’ Overview page.