Astellas Pharma won Food and Drug Administration approval for a rival to Apellis Pharmaceuticals' eye-disease treatment Syfovre and embattled APLS stock toppled again.
The Astellas approval comes via its recent acquisition of Iveric Bio. Over the weekend, the FDA signed off on the drug, Izervay, as a treatment for geographic atrophy. Meanwhile, Apellis stock has struggled as of late after the company confirmed a handful of patients have experienced swelling in their eyes following Syfovre injections.
Wedbush analyst Laura Chico noted the Izervay approval wasn't expected until later this month.
"With a second competitor in the market, this admittedly shifts the Syfovre prescribing calculus for physicians," she said in a note to clients.
On today's stock market, APLS stock tumbled 3.6% to close at 23.65, paring much steeper losses in earlier action. Astellas stock surged 10.6% to 15.40.
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There are key differences between Astellas' Izervay and Apellis' Syfovre. Izervay is given every 28 days while the label for Syfovre recommends administration every 25 to 60 days, Chico said.
Investors in APLS stock will likely focus on the emergence of retinal vasculitis, a side effect the American Society of Retina Specialists noted in a letter last month. As of July 29, there were seven cases of retinal vasculitis among more than 68,000 vials of Syfovre distributed.
Apellis says it hasn't discovered any manufacturing issues impacting the quality of Syfovre. The company also hasn't found any quality issues or contaminant. Further, it hasn't indicated a single drug lot involved in the side effects.
"It remains unclear how long the assessments will take to uncover potential drivers," Chico said. "With a new product now available for geographic atrophy in Izervay, we presume physicians will be less incentivized to trial Syfovre amidst uncertainty around the safety events."
She cut her price target to 29 from 32 and kept her neutral rating on APLS stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
