Outlook Therapeutics Resubmits Key Drug BLA to FDA, Decision Expected in 60 Days
OTLK has more than doubled off its 52-week low of $0.161 on elevated volume (2.4× avg).
Summary
Outlook Therapeutics has resubmitted its Biologics License Application (BLA) for ONS-5010/LYTENAVA™ to the FDA for neovascular age-related macular degeneration. This follows the FDA's May 26th decision to grant the company's appeal, which confirmed substantial evidence of effectiveness and removed the need for additional trials. The resubmission is designated as Class 1, meaning an FDA decision is expected within 60 days. This approval is critical for the company, which recently reported a 'going concern' warning and has undertaken significant dilutive financing. The market will be watching for the FDA's decision within the next two months.
At the time of this announcement, OTLK was trading at $0.74 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $88.2M. The 52-week trading range was $0.16 to $3.39. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.