Investing.com — Shares of Apellis Pharmaceuticals (NASDAQ:APLS) fell 8.9% in premarket trading following news that the FDA accepted a revised supplemental application from competitor Astellas Pharma for its eye drug, potentially leading to an earlier approval than expected.
The update has led to a reassessment of the market outlook for Apellis’ own eye drug, Syfovre, according to Jefferies.
The move comes as a blow to Apellis, with Jefferies indicating that the bull case for Syfovre is diminishing. The market had previously responded positively to Apellis’ prospects after the FDA issued a complete response letter to Astellas, but this sentiment has been challenged by the recent development.
RBC Capital Markets echoed this sentiment, suggesting that the anticipated dosing regimen advantage for Syfovre on its label may no longer be a sustainable competitive edge. Lisa Walter from RBC Capital Markets, with a sector perform rating and a price target of $26, emphasized the negative impact on Apellis shares, which had gained momentum since the FDA’s initial response to Astellas.
Despite the setback, Jefferies analyst Akash Tewari, who maintains a buy rating with a price target of $33, noted that there could still be near-term incremental upside for Syfovre. This optimism is based on certain Medicare Advantage plans favoring Syfovre over Astellas’ Izervay.
Piper Sandler’s Biren Amin provided further insight, stating that the FDA’s decision to classify the filing as a Class 1 resubmission suggests only minor changes were made to Astellas’ application. Amin’s comments highlight that Izervay is likely on a fast track for label expansion and lifting the 1-year use restriction, which could further intensify competition in the eye drug market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
