OTLK News & Events

Outlook Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted the appeal following completion of the Formal Dispute Resolution, FDR, process with the Office of New Drugs, OND. The FDA concluded that substantial evidence of effectiveness has been established for Lytenava for the treatment of neovascular age-related macular degeneration, nAMD. As a result, Outlook Therapeutics expects to resubmit the ONS-5010/Lytenava Biologics License Application, BLA, in June 2026.

Reports Q2 revenue $128,000, consensus $4.4M. "We remain committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval. Our objective is clear: to bring the first FDA-approved ophthalmic formulation of bevacizumab to patients in the United States," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "In addition, we are encouraged by the continued momentum of our European commercial launch of LYTENAVA, highlighted by our expansion into new markets, as well as our recently announced partnership in Switzerland and growing physician adoption in our initial launch countries."

Outlook Therapeutics announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16.129M shares of its common stock at an offering price of 31c per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the company will issue unregistered warrants to purchase up to an aggregate of 16.129M shares of common stock at an exercise price of 31c per share. The unregistered warrants will become exercisable on the later of the date of stockholder approval of the issuance of the shares underlying the warrants and the effective date of an amendment to the company's certificate of incorporation to increase the authorized shares of the company and will expire five years following the later of the date the unregistered warrants are first exercisable and the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about April 23, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.