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The U.S. Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’ (NASDAQ:APLS) Syfovre for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), the company announced Tuesday.
The approval to treat GA is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months. Syfovre is the first and only FDA-approved treatment for GA.
“Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that Syfovre will make a meaningful difference in the lives of people with GA,” commented Cedric Francois, co-founder and chief executive officer of Apellis.
Apellis shares are currently up more than 10% on the news.
Reacting to the announcement, Stifel analysts told investors in a research note that the approval locks in the biopharmaceutical company’s first-to-market position and quiets “lingering concerns after an unconventional regulatory process.”
“Importantly, Syfovre gained a broad label with treatment indicated for intervals every 24-60 days—giving flexibility to dose according to patient needs—and no unexpected safety findings over 24 months,” the analysts wrote. “Given the unusual developments during review, we expect APLS shares to finally break out of its volatile range.”
BofA analysts maintained a Buy rating on the stock but lifted the price target to $115 from $79, stating that Apellis management’s “mic drop moment arrives.”
“Overall, we are very encouraged by today’s update as the approval confirms our long-standing thesis that the totality of data and high unmet need warrant peg’s approval in GA,” said the analysts.
“Our recent doctor checks suggest that both doctors and patients are excited about Syfovre’s adoption. Our doctors expect to use the drug in 20-50% of their pts and anticipate 70-80% compliance rate with EOM use preference. We model 2023 and 2024 sales estimates of $70mn and $240mn, respectively.”
