OTLK Stock Crashes 67% in a Week: Here's What You Need to Know

Core Viewpoint - Outlook Therapeutics' shares have dropped 66.5% in a week following the FDA's third complete response letter (CRL) rejecting the biologics license application (BLA) resubmission for ONS-5010, an ophthalmic formulation aimed at treating wet age-related macular degeneration (wet AMD) [2][7]. Regulatory Challenges - The FDA first issued a CRL in 2023 due to concerns regarding chemistry, manufacturing, and controls, as well as a lack of substantial evidence, necessitating a second study, the NORSE EIGHT study [3]. - A subsequent CRL in August 2025 cited insufficient evidence of efficacy, as ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT study [4]. - In the latest CRL, the FDA stated that additional data submitted in the November 2025 resubmission did not change its previous assessment, reiterating the need for confirmatory evidence without specifying acceptable forms [5]. Market Performance - Over the past six months, Outlook Therapeutics' shares have plummeted 72%, contrasting with the industry's growth of 19.1% [6]. Product Launch and Approvals - Despite setbacks in the U.S., Outlook Therapeutics has secured EU and UK approval for Lytenava, launching the drug in Germany and the UK in June 2025 [10][11]. - Lytenava is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in adults within the EU and UK, providing a regulated alternative to off-label Avastin [11]. Future Strategies - Outlook Therapeutics is exploring all available pathways for potential approval of ONS-5010 in the U.S. and is committed to providing alternatives to compounded Avastin [9]. - The company is also evaluating strategic collaborations for expanding its commercial footprint in additional European markets [12].