Outlook Therapeutics Inc OTLK shares are trading higher after the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for wet age-related macular degeneration (wet AMD).
The shares are trading higher on a strong session volume of 4.485 million compared to an average volume of 160.790K, as per data from Benzinga Pro.
Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO, and NORSE THREE.
If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA.
Last year, Outlook Therapeutics completed the requested Type A Meetings with the FDA to discuss the Complete Response Letter (CRL).
The company received the letter in August regarding the Biologics License Application (BLA) for ONS-5010.
The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required to approve ONS-5010 for wet AMD.
ONS-5010/LYTENAVA is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for wet AMD and other retinal diseases.
Price Action: OTLK shares are up 36.40% at $9.61 on the last check Friday.
Photo by Amanda Dalbjörn on Unsplash
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