FDA accepts resubmitted BLA from Outlook Therapeutics

17 June 2026

Outlook Therapeutics (Nasdaq: OTLK) shares climbed more than 25% to $1.46 on Tuesday, after the company said the US Food and Drug Administration (FDA) has accepted its resubmitted biologics license application (BLA) for ONS-5010/Lytenava as a treatment for age-related macular degeneration (AMD), a condition in which retina damage results in vision loss.

The resubmission has been designated a Class 1 review by the FDA, with a target action date of July 29, 2026.

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