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Outlook Therapeutics Resubmits Biologics License Application

Story Highlights
  • Outlook Therapeutics resubmitted its Biologics License Application for ONS-5010 to the FDA.
  • The resubmission aims to resolve issues from a previous Complete Response Letter, potentially leading to U.S. approval.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Outlook Therapeutics Resubmits Biologics License Application

TipRanks Black Friday Sale

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

On November 3, 2025, Outlook Therapeutics announced the resubmission of its Biologics License Application for ONS-5010 to the U.S. FDA, following a productive meeting with the agency in September 2025. This step aims to address issues raised in a Complete Response Letter received in August 2025, potentially paving the way for U.S. approval and expanding its market presence in the treatment of wet age-related macular degeneration.

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™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD.

Average Trading Volume: 3,839,428

Technical Sentiment Signal: Sell

Current Market Cap: $55.97M

For a thorough assessment of OTLK stock, go to TipRanks’ Stock Analysis page.

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