Outlook Therapeutics Falls as FDA Decision Looms Over Mounting Losses
The company reported its first-ever annual revenue but a net loss of $62.4 million, with its future hinged on a year-end FDA ruling for its lead eye drug after two prior rejections.
Shares of Outlook Therapeutics (NASDAQ: OTLK) fell sharply after the biopharmaceutical firm announced its first full-year revenue alongside a significant net loss, placing intense pressure on a make-or-break regulatory decision for its lead drug candidate expected by December 31.
In morning trading following the release of its fiscal year 2025 results, the company's stock dropped 8.8% to $2.07. The report presented a mixed financial picture: Outlook Therapeutics recorded its first-ever revenue of $1.4 million, a milestone derived from the initial commercial launch of its lead product in Europe. However, this was overshadowed by a net loss of $62.4 million, or $1.79 per share, for the year.
The company's financial footing is a primary concern for investors. Its cash and cash equivalents have declined to $8.1 million, a stark figure for a company navigating the final, costly stages of seeking U.S. regulatory approval. This cash position intensifies the importance of the upcoming decision from the U.S. Food and Drug Administration (FDA).
All eyes are on the FDA's ruling on the Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab trade-named LYTENAVA™, intended for treating wet age-related macular degeneration (wet AMD), a leading cause of vision loss in older adults. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025.
This review marks Outlook's third attempt to get its flagship product approved in the U.S., a history that adds significant risk. The FDA issued a Complete Response Letter (CRL) in August 2023, citing manufacturing issues and a need for more substantial evidence. The company faced a second setback in August 2025, when the agency again issued a CRL related to a lack of substantial evidence of effectiveness.
In November, the company announced the FDA's acceptance of its latest BLA resubmission as a Class 1 response. This classification typically entails a more narrow review focused on specific, previously identified issues and comes with a shorter, two-month review timeline, leading to the current year-end PDUFA date.
An approval for LYTENAVA™ could be transformative for the company, unlocking a multi-billion dollar market currently dominated by higher-priced alternatives. The active ingredient, bevacizumab, is already widely used off-label to treat wet AMD, and Outlook's strategy is to offer the first officially FDA-approved ophthalmic version, which could capture significant market share. Analyst consensus reflects this potential, with an average price target of $6.25, suggesting a nearly 200% upside from its current levels should the FDA grant approval.
However, the path is precarious. A third rejection from the FDA would be catastrophic, likely sending shares tumbling and raising serious questions about the company's viability given its dwindling cash reserves. For Outlook Therapeutics and its investors, the final days of December represent a binary event that will either validate its long-fought scientific and regulatory strategy or mark a significant, and potentially final, failure.