Outlook Therapeutics Stock Jumps as FDA Accepts Lytenava BLA, July Decision Looms
Outlook Therapeutics, Inc. stock surged Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted Biologics License Application, or BLA, for ONS-5010/LYTENAVA as a treatment for wet age-related macular degeneration. A BLA is the FDA application used to seek approval to market a biologic medicine. OTLK traded at $1.51, up about 30.2% from its previous close of $1.16, with intraday volume above 33.7 million shares, according to market data available in afternoon trading. The move was driven by a clearer and faster regulatory timeline. Outlook said the FDA classified the resubmission as a Class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29, 2026. The PDUFA date is the FDA’s goal date to act on an application, not a guarantee of approval. Chief Executive Bob Jahr said the company was “very pleased” that the FDA accepted the application and called it “great news for Outlook and the LYTENAVA™ team, patients and the retina community.”
