Chardan Capital Markets Downgrades Outlook Therapeutics Incs. (OTLK) to Neutral

Chardan Capital Markets analyst Daniil Gataulin downgraded Outlook Therapeutics Incs. (NASDAQ: OTLK) from Buy to Neutral.

The analyst comments: "Outlook Therapeutics has reported preliminary topline efficacy and safety data from the Phase 3 NORSE 8 study of Lytenava (ophthalmic formulation of bevacizumab) in patients with wet AMD. The study did not meet the primary endpoint of non-inferiority compared to ranibizumab (Lucentis) at 8 weeks. Nonetheless, the company believes the benefit seen at 8 weeks (improvement in BCVA of 4.2 letters in NORSE 8), the successful NORSE 2 study, and clean safety support the path forward for Lytenava and plans to re-submit the BLA in 1Q25 (pending full 3-month data in January 2025). However, given the FDA's requirement for two successful adequate and well-controlled studies for approval in wet AMD, we don't believe NORSE 8, missing the primary endpoint, will serve as the second such study. Consequently, given the uncertainty in Lytenava regulatory path forward in the U.S., we downgrade our OTLK rating to Neutral (price target under review)."

For an analyst ratings summary and ratings history on Outlook Therapeutics Incs. click here. For more ratings news on Outlook Therapeutics Incs. click here.

Shares of Outlook Therapeutics Incs. closed at $2.05 yesterday.

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