Outlook Therapeutics (OTLK) Gets July 29 PDUFA Date for LYTENAVA

Outlook Therapeutics, Inc. (NASDAQ:OTLK) is one of the 10 High Growth Stocks Insiders Are Buying.

On June 16, 2026, Outlook Therapeutics, Inc. (NASDAQ:OTLK) announced that the U.S. Food and Drug Administration acknowledged receipt of the resubmission of the Biologics License Application for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration, or wet AMD. The company was informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.

CEO Bob Jahr said the FDA accepted the resubmitted BLA to review the labeling as part of the “final step toward potential approval.” Outlook said ONS-5010/LYTENAVA would be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance if approved. The company has initiated pre-launch activities in anticipation of the pending BLA approval.

Earlier in June, Outlook Therapeutics announced the resubmission of its BLA to the FDA for ONS-5010/LYTENAVA for the treatment of nAMD. The company said it successfully appealed the December 2025 Complete Response Letter related to the ONS-5010 BLA. The FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA for the treatment of nAMD, and that additional trials are not required. Outlook said the formal decision indicated a Class 1 resubmission, with a PDUFA date and decision expected within 60 days of FDA receipt.

Outlook Therapeutics, Inc. (NASDAQ:OTLK) focuses on developing and commercializing monoclonal antibodies for ophthalmic indications.

READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy.

Disclosure: None. Follow Insider Monkey on Google News.