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Outlook Therapeutics’ FDA Review for ONS-5010 Resubmission

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Outlook Therapeutics’ FDA Review for ONS-5010 Resubmission

TipRanks Black Friday Sale

An update from Outlook Therapeutics ( (OTLK) ) is now available.

On November 13, 2025, Outlook Therapeutics announced that the FDA acknowledged receipt of its resubmitted Biologics License Application for ONS-5010, a bevacizumab-vikg product. The FDA classified the application as a Class 1 review, setting a two-month review period and a PDUFA goal date of December 31, 2025, which could significantly impact the company’s market positioning and stakeholder interests.

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, Inc. operates in the biopharmaceutical industry, focusing on developing and commercializing monoclonal antibody therapeutics for various ophthalmic indications.

Average Trading Volume: 3,768,584

Technical Sentiment Signal: Sell

Current Market Cap: $56.86M

Find detailed analytics on OTLK stock on TipRanks’ Stock Analysis page.

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