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 ...
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 – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst ...
A real-world study of pegcetacoplan for treatment of geographic atrophy showed significantly better outcomes than the pivotal clinical trials in patients who had symptomatic vision loss.
We recently compiled a list of the 10 Largest Biotech Hedge Funds and Their Top Stock Picks. In this article, we are going to ...
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 ...
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. European drug regulators have officially turned ...
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for ...
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS)’s two primary revenue generating treatments EMPAVELI and SYFOVRE are primarily targeted towards people with eye diseases. The firm is also trying to ...
However, the CHMP confirmed its refusal of a marketing authorization for Syfovre (pegcetacoplan) to treat geographic atrophy secondary to ARMD. The EMA said that both Afqlir and Opuviz had quality ...