- Outlook Therapeutics ( NASDAQ: OTLK ) on Tuesday said it had resubmitted its biologics license application (BLA) to the U.S. FDA for its investigational therapy ONS-5010 for the treatment of eye disease wet age-related macular degeneration.
- Shares of the small-cap biopharmaceutical company rose 8% to $1.21 in premarket trading.
- The BLA had initially been submitted by the company in March this year, but then OTLK voluntarily withdrew the submission in May to provide additional information requested by the FDA.
- OTLK CEO Russell Trenary in June had said that the company hoped to resubmit the BLA to the FDA by Sept. , with today's announcement meaning that the timeline was on track.
- "We believe that this re-submission addresses each of the comments and recommendations from the Agency, and we are confident in the revised BLA application," Trenary said in Tuesday's statement .
- The company anticipates potential FDA marketing approval for ONS-5010 in 2023. The therapy would be branded as Lytenava if approved.
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Outlook Therapeutics resubmits application for eye disease wAMD drug, shares rise 8%