Outlook Therapeutics Inc. (OTLK) Soars 11.97% on FDA Decision Anticipation

Outlook Therapeutics Inc. (OTLK) saw a significant rise of 11.97% in pre-market trading on August 18, 2025, driven by anticipation surrounding the FDA's decision on its investigational ophthalmic formulation of bevacizumab, ONS-5010, for the treatment of wet age-related macular degeneration (wet AMD).

This decision, scheduled for August 27, 2025, marks the company's second attempt to secure FDA approval for ONS-5010, which was previously denied in August 2023 due to issues related to chemistry, manufacturing, and controls (CMC), as well as the need for additional confirmatory clinical evidence. The company resubmitted its Biologics License Application (BLA) for ONS-5010 in February 2025, addressing the concerns outlined in the Complete Response Letter issued by the FDA.

If approved, ONS-5010 will be branded as LYTENAVA in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity. LYTENAVA was already approved in the EU for the treatment of wet AMD in May 2024, highlighting its potential as a significant therapeutic option for patients suffering from this debilitating condition.