Apellis, CHMP
Apellis Pharmaceuticals declines afters CHMP's third negative opinion on Syfovre
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for its eye disease therapy for the third time this year. Apellis reported that the Committee for Medicinal Products for Human Use,
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.
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 Pharmaceuticals, Inc.: Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan In Geographic Atrophy, Stock Down
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the
Buy Rating on Apellis Pharmaceuticals Anchored in Syfovre’s Market Share Potential Despite EU Setback
Apellis Pharmaceuticals (APLS – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst ...
Investor's Business Daily on MSN1d
Apellis Stock Hammered After Eye Drug Gets A Third European Rejection
European regulators rejected Apellis Pharmaceuticals' embattled eye drug, Syfovre, and Apellis stock tumbled to a month-low.
BioPharma Dive1d
Apellis eye drug again turned back in Europe
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 Pharmaceuticals Hold Rating Justified Amidst EU Setbacks and Market Challenges
Analyst Derek Archila of Wells Fargo assigned a Hold rating on Apellis Pharmaceuticals (APLS – Research Report), retaining the price ...
Insider Monkey7d
Apellis Pharmaceuticals, Inc. (APLS): Among Hedge Funds’ Top Biotech Stock Picks
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 ...
WebMD10d
Syfovre for Geographic Atrophy: What You Need to Know
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 ...
Yahoo Finance1mon
Apellis (APLS) Q2 Earnings Beat, Syfovre Sales Drive Revenues
Syfovre sales missed the Zacks Consensus Estimate of $158 million but beat our model estimate of $148 million for the reported quarter. Apellis delivered more than 79,000 commercial vials and ...