Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy,
Apellis: CHMP Once Again Recommends Against Syfovre
The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able to submit new data in support of its application following an unrelated court ruling in Europe.
Investor's Business Daily on MSN1d
Apellis Stock Hammered After Eye Drug Gets A Third European RejectionEuropean regulators rejected Apellis Pharmaceuticals' embattled eye drug, Syfovre, and Apellis stock tumbled to a month-low.
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the ...
Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for ...
Syfovre, also known as pegcetacoplan, is a medicine used to treat geographic atrophy, which is the advanced form of dry age-related macular degeneration. Geographic atrophy can cause irreversibl ...
“We have continued to execute well and progress our programs over the past six months. SYFOVRE delivered strong growth and is reaching more people living with geographic atrophy, EMPAVELI ...
Both Izervay and Syfovre are eye injections used to treat geographic atrophy caused by AMD. They work similarly to one another to manage this condition. Because of this, they can cause some ...
Its products include EMPAVELI and SYFOVRE. The company was founded by Candace Rose Depp, Pascal Deschatelets, Cedric Francois, and Alec Machiels on September 25, 2009 and is headquartered in ...
Initiated a re-examination of the marketing authorization application of SYFOVRE with the European Medicines Agency (EMA); expect a final decision in 4Q 2024 Plan to report topline Phase 3 data ...
Analyst Derek Archila of Wells Fargo assigned a Hold rating on Apellis Pharmaceuticals (APLS – Research Report), retaining the price ...
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