On July 24, the FDA approved Lytenava, a new treatment for wet age-related macular degeneration (AMD), two days before the expected deadline.
Lytenava is the first ophthalmic formulation of bevacizumab to receive FDA approval for wet AMD in the United States.
Following the news, Outlook Therapeutics' stock jumped nearly 9% in pre-market trading Monday, after climbing 6% on Friday to close at $1.41.
BTIG reacted swiftly by upgrading OTLK from Neutral to Buy, assigning a price target of $4.00, citing the $8.5 billion U.S. anti-VEGF retina market as a major growth opportunity.
Analysts remain divided on Outlook's outlook: two rate it a Buy, two a Hold, with an average 12-month price target of $5.50, suggesting nearly 290% upside from current prices. The highest target reaches $10, while the lowest falls to $0.50.
The FDA approval marks a turnaround from December 2025 when the agency initially rejected the application, demanding more clinical data. Outlook appealed, and by May, the FDA accepted the existing evidence, allowing the company to resubmit in June.
Outlook estimates millions of bevacizumab eye injections occur annually in the U.S., mostly off-label. Lytenava is expected to become available to eligible American patients before the end of 2026, supported by a growing retina-focused sales force and expanded patient and reimbursement assistance programs.
Lytenava has already launched commercially in Germany, Austria, and the UK after receiving regulatory approval in the European Union and United Kingdom. The company anticipates 12 years of U.S. market exclusivity under biologics law.
The stock recently stopped falling below $1, regaining Nasdaq compliance and reducing delisting risks that weighed on it earlier this year.
