Outlook Therapeutics

The FDA granted Outlook Therapeutics’ appeal, finding that there is substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) in neovascular age-related macular degeneration. The company plans to refile the Biologics License Application in June 2026; this will be a class 1 re-submission with an expected PDUFA target date to be set within 60 days of receipt. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic bevacizumab formulation with an approved manufacturing process, labeling and pharmacovigilance program. » Mais em de.investing.com

Outlook Therapeutics sold 16,129,033 common shares at $0.31 each, raising approximately $5.0 million gross before fees. At the same time, unregistered warrants for up to 16,129,033 shares with an exercise price of $0.31 were issued; upon shareholder approval their exercise could generate up to an additional $5.0 million in gross proceeds. The company also reduced the exercise price of certain outstanding warrants for up to 2,142,854 shares from $2.26 to $0.31. Net proceeds are expected to be used primarily for working capital and general corporate purposes; Outlook Therapeutics is focused on the development and commercialization of bevacizumab for retinal diseases. » Mais em de.investing.com

Outlook Therapeutics has agreed to sell 16,129,033 common shares or prepaid warrants at $0.31 each in a registered direct offering and expects gross proceeds of approximately $5.0 million before fees. At the same time, unregistered warrants are being issued that entitle holders to purchase the same number of shares at $0.31 and will be exercisable following shareholder approval, which if fully exercised could generate an additional $5.0 million. The exercise price of certain previously issued warrants is being reduced to $0.31. Net proceeds are intended for working capital and general corporate purposes; H.C. Wainwright & Co. is acting as placement agent, and the stock trades around $0.32 with a market capitalization of $33.41 million. » Mais em de.investing.com