EX-99.1 2 tm2618010d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026 ISELIN, N.J., June 16, 2026 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026. “We are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “This is great news for Outlook and the LYTENAVA™ team, patients and the retina community. We look forward to collaborati…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Outlook Therapeutics, Inc.
OTLKNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On June 16, 2026, Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the “FDA”) had acknowledged receipt of its resubmission of the Biologics License Application (the “BLA”) for ONS-5010 (bevacizumab-vikg). The FDA determined that the BLA is a Class 1 review, which results in a 60-day review period from the date of resubmission.…
Company context
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA is the only ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD.