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- Outlook Therapeutics (NASDAQ:OTLK) lost ~74% of its market value in the pre-market Wednesday after announcing that the U.S. FDA declined to approve its wet AMD candidate, ONS-5010. Also known as wet age-related macular degeneration, wet AMD can lead to rapid vision loss.
- ONS-5010 is an ophthalmic formulation of the cancer therapy bevacizumab that the company plans to market as Lytenava intravitreal injection for multiple eye diseases, including Wet AMD.
- In a so-called Complete Response Letter (CRL) issued in relation to the company's Biologics License Application (BLA), the regulator has cited several manufacturing issues and the need to obtain additional confirmatory clinical evidence.
- Outlook (OTLK) intends to request a meeting with the FDA to resolve the issues cited in the BLA.
- "Following this meeting with the FDA, the company will be able to discuss next steps and the expected timing for resolution," CEO Russell Trenary remarked.
- In September 2022, Outlook (OTLK) partnered with drug distributor AmerisourceBergen (ABC) to prepare for the U.S. commercial launch of Lytenava, subject to FDA approval.
More on Outlook Therapeutics
- Outlook Therapeutics: August PDUFA May Be A Buy With Some Caveats
- Outlook draws bullish views at Cantor on potential FDA nod for lead asset
- Outlook Therapeutics GAAP EPS of -$0.31 in-line
- Outlook enters definitive agreement for $31.8M convertible promissory note
- FDA accepts Outlook Therapeutics' biologics license application for wet AMD drug
- Seeking Alpha’s Quant Rating on Outlook Therapeutics
- Earnings data for Outlook Therapeutics