FDA Issues Complete Response Letter to Outlook Therapeutics

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

On August 28, 2025, Outlook Therapeutics announced that the FDA issued a complete response letter for its biologics license application for ONS-5010, an investigational treatment for wet AMD, due to insufficient evidence of effectiveness. The company plans to work with the FDA to address this issue and is committed to providing a safe alternative to compounded Avastin. Despite this setback, Outlook Therapeutics continues to expand its market presence in Europe, where LYTENAVA™ has been granted marketing authorization and is commercially available in Germany and the UK.

The most recent analyst rating on (OTLK) stock is a Hold with a $1.00 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 Underperform.

Outlook Therapeutics is facing critical financial challenges with no revenue and high leverage, posing substantial risks. The technical analysis shows weak momentum with mixed signals, while the valuation indicates non-profitability. These factors collectively suggest a low stock score.

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

More about Outlook Therapeutics

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD.

Average Trading Volume: 2,805,768

Technical Sentiment Signal: Sell

Current Market Cap: $37.81M

See more data about OTLK stock on TipRanks’ Stock Analysis page.