Outlook Therapeutics Resubmits BLA for LYTENAVA to FDA; OTLK Shares Rise

Outlook Therapeutics Inc. (NASDAQ: OTLK) resubmitted its Biologics License Application to the U.S. Food and Drug Administration for LYTENAVA, an ophthalmic formulation of bevacizumab, as a treatment for wet age-related macular degeneration. Shares of the company rose following the announcement on Monday, June 1, 2026. The resubmission addresses issues raised in a prior complete response letter from the FDA. The agency had previously declined to approve the application, citing deficiencies identified during a pre-approval manufacturing inspection and the need for additional confirmatory clinical evidence. Outlook said the new filing includes supplementary data and manufacturing updates requested by regulators. Wet AMD is a leading cause of vision loss among the elderly, affecting millions worldwide. If approved, LYTENAVA would compete in a market dominated by branded anti-VEGF therapies. The FDA typically reviews resubmitted BLAs within six months. Outlook previously reported retaining Cencora, formerly known as AmerisourceBergen, to support a potential U.S. commercial launch.