Apellis(APLS)
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Apellis(APLS) - 2024 Q3 - Quarterly Report
2024-11-05 11:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38276 APELLIS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 27-1537290 (State or othe ...
Pivotal VALIANT Results Presented at Kidney Week Highlight Strength of Pegcetacoplan Treatment Effect in Patients with C3G / Primary IC-MPGN
GlobeNewswire News Room· 2024-10-26 18:00
Statistically significant 68% (p<0.0001) proteinuria reduction compared to placebo, with reduction observed as early as Week 4 All secondary endpoints favored treatment with pegcetacoplan, including: Stabilized eGFR, a key measure of kidney function 71% of patients achieved zero C3c staining intensity, demonstrating complete clearance of C3c deposits Results consistent across subgroups including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneysDemonstrated favorable safe ...
Syfovre's Competitive Edge Highlights Bright Future For Apellis Pharmaceuticals, Analyst Initiates With Bullish Pitch
Benzinga· 2024-10-16 18:56
William Blair has initiated coverage on Apellis Pharmaceuticals, Inc. APLS and notes that Apellis was the first company to successfully target complement C3, which has led to the approval of two therapies: Empaveli (systemic pegcetacoplan) for paroxysmal nocturnal hemoglobinuria and Syfovre (intravitreal pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration.William Blair writes that although Empaveli has established a solid position in the PNH market, short-term challenges are ...
Apellis: Weighing Syfovre's Rapid Expansion Against Risks In The GA Market (Rating Upgrade)
Seeking Alpha· 2024-10-04 09:31
Hey there! I'm a biotech and healthcare investment analyst with several years of bedside clinical experience and a Master of Business Administration. I utilize risk-return charts and DCF analyses to highlight investment opportunities and risks. I'm a big fan of the barbell strategy: 90% in safe assets like Treasuries and ETFs, and 10% in high-growth stocks—keeping risk management front and center. Since markets are pretty efficient and returns can be random, I draw inspiration from 'Superforecasting' and 'A ...
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 ...