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.
The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...
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.
Analyst Derek Archila of Wells Fargo assigned a Hold rating on Apellis Pharmaceuticals (APLS – Research Report), retaining the price ...
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 ...
Apellis Pharmaceuticals (APLS) is down more than -9% after the European Medicines Agency upheld its negative opinion on the marketing authorization for the company’s Syfovre eye drug. Frontline Plc ...
“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 ...
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 ...
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