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Outlook Therapeutics Completes FDA Meeting on ONS-5010

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Outlook Therapeutics Completes FDA Meeting on ONS-5010

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Outlook Therapeutics ( (OTLK) ) just unveiled an announcement.

On September 29, 2025, Outlook Therapeutics announced the completion of a Type A Meeting with the U.S. FDA to discuss the complete response letter regarding the BLA resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet AMD. Based on the discussions, the company plans to resubmit the BLA by the end of 2025, aiming to provide a safe and effective treatment option for wet AMD in the U.S. market.

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 optimize 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. Outlook Therapeutics has commenced commercial launch of LYTENAVA™ in Germany and the UK.

Average Trading Volume: 3,364,096

Technical Sentiment Signal: Sell

Current Market Cap: $43.09M

See more insights into OTLK stock on TipRanks’ Stock Analysis page.

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