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 ...
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the ...
This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the ...
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for ...
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Apellis Pharmaceuticals shares are moving lower after the Committee for Medicinal Products for Human Use of the European Medicines Agency confirmed its June 2024 negative opinion following ...
The firm's stance comes ahead of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) expected final opinion on the approval of Apellis's drug pegcetacoplan ...
Mizuho has reiterated its Neutral rating on Apellis Pharmaceuticals (NASDAQ: NASDAQ:APLS) with a steady price target of $42.00. The firm's stance comes ahead of the European Medicines Agency's (EMA) ...
Apellis said it was expecting the CHMP’s decision after the panel indicated it was minded to reject the application in December and added that it would seek “immediate re-examination” of the ...
Apellis’ C3 inhibitor Aspaveli (pegcetacoplan) is an option for C5 inhibitor non-responders, but also has to be delivered through a needle. The CHMP’s decision is based on the results from the ...