European regulators rejected Apellis Pharmaceuticals' embattled eye drug, Syfovre. Apellis stock tumbled to a month-low.
The Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency, confirmed the negative opinion its issued in June for pegcetacoplan. Pegcetacoplan is the test name for Syfovre, which Apellis sells in the U.S. for patients with geographic atrophy related to age-related macular degeneration.
"We are deeply disappointed by this outcome, which leaves millions of Europeans with GA without a treatment for this irreversible form of blindness," Apellis Pharmaceuticals Chief Executive Cedric Francois said in a statement.
He noted eye doctors in Europe broadly support pegcetacoplan and multiple members of the CHMP group disagreed with the decision to reject approval.
On today's stock market, Apellis stock slumped 11.5% to close at 32.51.
Apellis Pharmaceuticals Faced Numerous Obstacles
Syfovre has faced its fair share of battles.
It's been on the market in the U.S. since early 2023. But in mid-2023, a specialist group noted some patients experienced eye inflammation following the Syfovre injection. The company later identified variations in a specific needle size used to draw the Syfovre solution out of the vial. Those variations could have led to the side effect, Apellis said.
Later, European regulators issued negative opinions for pegcetacoplan in early and mid-2024. CHMP members didn't feel there was enough evidence to support the drug's benefit.
"There were reportedly several dissenting votes by CHMP members, but ultimately, the negative opinion was based mainly on the view that there is insufficient evidence that Syfovre leads to clinically meaningful functional improvements in GA patients," Needham analyst Joseph Stringer said in a client note.
At this point, Apellis Pharmaceuticals is "out of European approval options," he said. The company isn't currently planning to run another Phase 3 study in Europe.
Apellis Stock Is Under Pressure
Stringer kept his buy rating on Apellis stock. He hadn't expected European approval of the drug.
Mizuho Securities analyst Graig Suvannavejh, who had modeled approval of pegcetacoplan in Europe, cut his price target on Apellis stock to 39 from 42, but kept his neutral rating.
Apellis Pharmaceuticals shares are now trading well below their 50-day moving average, according to MarketSurge chart analysis.
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