Apellis(APLS)

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Apellis Pharmaceuticals: Assessing The Impact Of The Negative CHMP Opinion
Seeking Alpha· 2024-10-01 17:15
Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial.It has been almost a year since my previous Apellis Pharmaceuticals, Inc. (NASDAQ: APLS ) article , where I discussed the company's C3 inhibitor technology, as well as the prospects for their flagship treatment, pegcetacoplan. Despite my trepidation abou ...
Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU
ZACKS· 2024-09-23 16:26
Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Shares of the company lost 11.5% on Friday in response.Management expressed deep disappointment in the outcome, stating that millions of GA patients in the EU remain without treatmen ...
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
GlobeNewswire News Room· 2024-09-20 09:00
WALTHAM, Mass., Sept. 20, 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 confirmed its June 2024 negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. “We are deeply disappointed by this outcome, which leaves millions of Europeans with GA ...
Sobi and Apellis announce positive topline results from phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN
Prnewswire· 2024-08-08 11:32
Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys Demonstrated favourable safety, consistent with established profile Companies plan to submit data for regulatory approval in the US and EU STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pha ...
Sobi and Apellis announce positive topline results from phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN
Prnewswire· 2024-08-08 11:29
Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study populationPositive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneysDemonstrated favourable safety, consistent with established profileCompanies plan to submit data for regulatory approval in the US and EU STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceu ...
Apellis(APLS) - 2024 Q2 - Earnings Call Transcript
2024-08-01 21:59
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q2 2024 Results Conference Call August 1, 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 Anupam Rama - J.P. Morgan Yigal Nochomovitz - Citigroup Steven Seedhouse - Raymond James Colleen Kusy - Baird Phil Nadeau - TD Cowen Ivy Wang - Jefferies Eliana Merle - UBS ...
Apellis (APLS) Q2 Earnings Beat, Syfovre Sales Drive Revenues
ZACKS· 2024-08-01 15:06
Apellis Pharmaceuticals, Inc. (APLS) incurred second-quarter 2024 loss of 28 cents per share (excluding loss on extinguishment of development liability), narrower than the Zacks Consensus Estimate of a loss of 33 cents. The company had incurred a loss of $1.02 per share in the year-ago quarter.Total revenues amounted to $199.7 million in the reported quarter, beating the Zacks Consensus Estimate of $189.5 million. In the year-ago quarter, the company had reported revenues of $95 million.The top line skyrock ...
Compared to Estimates, Apellis Pharmaceuticals (APLS) Q2 Earnings: A Look at Key Metrics
ZACKS· 2024-08-01 14:36
For the quarter ended June 2024, Apellis Pharmaceuticals, Inc. (APLS) reported revenue of $199.69 million, up 110.3% over the same period last year. EPS came in at -$0.28, compared to -$1.02 in the year-ago quarter.The reported revenue represents a surprise of +5.39% over the Zacks Consensus Estimate of $189.47 million. With the consensus EPS estimate being -$0.33, the EPS surprise was +15.15%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expect ...
Apellis Pharmaceuticals, Inc. (APLS) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-01 13:15
Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $1.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.15%. A quarter ago, it was expected that this company would post a loss of $0.54 per share when it actually produced a loss of $0.54, delivering no surprise.Over the last four quarters, the company has sur ...
Apellis Pharmaceuticals Reports Second Quarter 2024 Financial Results
Newsfilter· 2024-08-01 11:05
Generated $199.7 million in 2Q 2024 revenues, including $179.1 million in U.S. net product sales $154.6 million for SYFOVRE® (pegcetacoplan injection) $24.5 million for EMPAVELI® (pegcetacoplan) Initiated a re-examination of the marketing authorization application of SYFOVRE with the European Medicines Agency (EMA); expect a final decision in 4Q 2024 Plan to report topline Phase 3 data with systemic pegcetacoplan in C3G / IC-MPGN in August 2024Cash and cash equivalents of $360.1 million as of June 30, 2024 ...