Outlook Therapeutics, Inc. is expanding the reach of LYTENAVA™ (bevacizumab gamma) in Europe, with a successful commercial launch in Austria in January 2026. Additional launches are expected in Europe in 2026, with a Type A meeting request submitted to the FDA for ONS-5010, an ophthalmic bevacizumab formulation for wet AMD treatment. Financial results for the first quarter of fiscal year 2026 show net loss attributable to common stockholders of $23.1 million. Adjusted net loss attributable to common stockholders was $13.5 million for the same period, with revenue negatively impacted by an increase in returns reserve for product returns in the UK. Unit sales of LYTENAVA in Europe doubled in the quarter ended December 31, 2025. As of December 31, 2025, Outlook Therapeutics had $8.7 million in cash and cash equivalents, excluding proceeds from sales post-December 31, 2025.
Outlook Therapeutics has requested a Type A meeting with the FDA to discuss the Complete Response Letter regarding the BLA for ONS-5010. The CRL identified a deficiency regarding evidence of effectiveness and recommended submission of additional confirmatory evidence. The company believes this determination is inconsistent with evidence submitted in the BLA. Ongoing discussions with the FDA have confirmed alignment on CMC, safety, and positive results from NORSE TWO.
ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) is an ophthalmic formulation of bevacizumab for wet AMD treatment. It has received Marketing Authorization in the EU and UK. In the US, it is investigational. Outlook Therapeutics continues to focus on enhancing the standard of care for bevacizumab in retina diseases. Non-GAAP financial measures are used to provide additional information on financial performance. The company prepares its financial statements in accordance with U.S. GAAP and uses NGFMs to evaluate core operating results and facilitate comparison across reporting periods. Outlook Therapeutics cautions investors about forward-looking statements and the risks associated with developing and commercializing pharmaceutical products.
Read more at GlobeNewswire: Outlook Therapeutics Reports First Quarter Fiscal Year 2026