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Apellis Announces Five Abstracts Accepted for Oral Presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting
GlobeNewswire News Room· 2024-07-09 11:00
Late-breaking presentation shows SYFOVRE® (pegcetacoplan injection) demonstrated visual function benefit on prespecified endpoint in GALE long-term extension study WALTHAM, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that six abstracts, five of which are oral presentations, will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 17 - 20 in Stockholm, Sweden. These data reinforce the robust effi ...
Apellis (APLS) Falls on Second Negative CHMP Opinion for GA Drug
ZACKS· 2024-07-01 13:45
Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the second time on the marketing authorization application (MAA) for intravitreal pegcetacoplan to treat geographic atrophy (GA) in the EU. Despite this decision, there were several dissenting votes among CHMP members.Apellis plans to request a re-examination of the opinion and anticipates a final decision in the fourth quarter of 20 ...
Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU
Newsfilter· 2024-06-28 10:57
WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re- examination and expects a final opinio ...
Apellis Plans to Seek Re-Examination Following Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU
GlobeNewswire News Room· 2024-06-28 10:57
WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion ...
Apellis (APLS) Up on Upbeat GA Data From Long-Term Syfovre Study
ZACKS· 2024-06-11 14:51
Apellis Pharmaceuticals (APLS) announced positive data from the late-stage GALE long-term extension study evaluating its marketed drug, Syfovre (pegcetacoplan injection), to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration.Per the data readout, presented at a recent medical conference, treatment with Syfovre in the GALE study preserved visual function at 36 months in the GA patients. Per Apellis, Syfovre is the only approved GA treatment to show a benefit on visual f ...
SYFOVRE® (pegcetacoplan injection) Preserved Visual Function at 36 Months in GALE Extension Study in Geographic Atrophy (GA)
Newsfilter· 2024-06-10 11:00
SYFOVRE is the only approved GA treatment to demonstrate a visual function benefit in a prespecified endpointData presented at the Clinical Trials at the Summit Meeting WALTHAM, Mass., June 10, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that SYFOVRE® (pegcetacoplan injection) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). These positive data from the GALE long-term extension study ...
Why Is Apellis Pharmaceuticals (APLS) Down 1.9% Since Last Earnings Report?
ZACKS· 2024-06-06 16:36
It has been about a month since the last earnings report for Apellis Pharmaceuticals, Inc. (APLS) . Shares have lost about 1.9% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is Apellis Pharmaceuticals due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Apellis’ Q1 Ea ...
Apellis (APLS) Posts Upbeat One-Year Kidney Diseases Study Data
zacks.com· 2024-05-27 17:36
Apellis Pharmaceuticals (APLS) , in collaboration with Sobi, reported positive one-year results from the midstage study evaluating systemic pegcetacoplan to treat post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). Pegcetacoplan is being developed as a targeted C3 therapy that addresses the cause of these rare and debilitating kidney diseases. Per the data readout, seven patients in the phase II NOBLE study, representing 64% of ...
Positive One-Year Data from Phase 2 Study of Pegcetacoplan in Post-Transplant Recurrence of C3G and IC-MPGN Presented as Late-Breaker at ERA Congress
Newsfilter· 2024-05-24 14:00
Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were clearedHighlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) and Sobi® (STO:SOBI) today announced positive one-year results from the Phase 2 NOBLE study investigating systemic pegcetacoplan, ...
Positive One-Year Data from Phase 2 Study of Pegcetacoplan in Post-Transplant Recurrence of C3G and IC-MPGN Presented as Late-Breaker at ERA Congress
globenewswire.com· 2024-05-24 14:00
Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were clearedHighlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced positive one-year results from the Phase 2 NOBLE study investigating systemic pegcetacoplan ...