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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
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 ...
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, ...
Apellis(APLS) - 2024 Q1 - Earnings Call Presentation
2024-05-07 20:03
First Quarter 2024 Financial Results Conference Call May 7, 2024 Apellis Participants CEDRI C F RANCO I S, M. D. , Ph . D. Co-Founder, President & Chief Executive Officer ...
Apellis(APLS) - 2024 Q1 - Earnings Call Transcript
2024-05-07 20:02
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q1 2024 Earnings Conference Call May 7, 2024 8:30 AM ET Company Participants Meredith Kaya - SVP of IR & Strategic Finance Cedric Francois - Co-Founder & CEO Adam Townsend - COO Caroline Baumal - Chief Medical Officer Tim Sullivan - CFO Conference Call Participants Jonathan Miller - Evercore Tazeen Ahmad - Bank of America Priyanka Grover - J.P. Morgan Salveen Richter - Goldman Sachs Yigal Nochomovitz - Citigroup Nicholas Econom - Raymond James Colleen Kusy - Baird ...
Apellis' (APLS) Q1 Earnings Match Estimates, Revenues Beat
Zacks Investment Research· 2024-05-07 16:21
Apellis Pharmaceuticals, Inc. (APLS) incurred a first-quarter 2024 loss of 54 cents per share, which matched the Zacks Consensus Estimate. The company had incurred a loss of $1.56 per share in the year-ago quarter.Total revenues amounted to $172.3 million in the reported quarter, beating the Zacks Consensus Estimate of $160.5 million. In the year-ago quarter, the company had reported revenues of $44.8 million.The top line skyrocketed 284% year over year, owing to higher sales of Syfovre (pegcetacoplan injec ...