Apellis Pharma

Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which develops novel therapeutic and complement immunotherapies for the treatment of complement-dependent autoimmune and inflammatory diseases through APL-2 product. The company was founded by Candace Rose Depp, Pascal Deschatelets, Cedric Francois, Alec Machiels on September 25, 2009 and is headquartered in Waltham, MA.

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Apellis Pharma reports strong Q1 revenue, eyes U.S. expansion

Apellis Pharma's Q1 2023 performance showcased strong revenue from SYFOVRE and EMPAVELI, with positive feedback and demand in the market.
While facing challenges like safety concerns and European commercialization, the company is focused on expanding market reach and driving awareness.
Opportunities lie in making SYFOVRE widely available, promoting patient education, and potential approval in Europe for further growth.

Apellis Pharma reports robust Q2 sales amidst safety event challenges

Apellis Pharma's Q2 performance highlighted strong sales, positive product efficacy, and proactive response to safety events
Despite challenges with rare safety events, the company's strengths in product credibility, manufacturing quality, and market acceptance shine through
Opportunities lie in enhancing physician education, exploring financing options, and leveraging positive efficacy evolution for market growth
Overall, Apellis Pharma's strategic measures position it well to navigate challenges, capitalize on opportunities, and maintain market confidence

Apellis Pharma reports mixed Q3 results, eyes European expansion

Apellis Pharma's Q3 performance showed strong revenue from key products but also highlighted the need for cost-saving measures. The company's focus on global expansion and product launches in Europe presents growth opportunities amidst market challenges.

Apellis Pharma reports strong Q4 earnings amidst market challenges

Apellis Pharma delivered strong financial results in Q4 2023, driven by the success of SYFOVRE and EMPAVELI in the U.S., while navigating challenges in the EU market and competitive landscape.
The company's strategic focus on patient access, market leadership, and R&D advancement positions it for continued growth and innovation in precision medicine, supported by robust engagement with medical communities.
Opportunities lie in expanding market share through bilateral treatments, advancing pipeline programs, and leveraging compliance and real-world data to strengthen Apellis Pharma's position as a leading provider of GA therapies.
Addressing challenges such as market competition, regulatory processes, and financial performance will be crucial for Apellis Pharma to sustain growth, optimize revenue, and drive profitability in the future.

Apellis Pharma reports robust Q1 performance and eyes expansion

Apellis Pharma (APLS) showcased strong financial performance and product success in Q1 2024, with plans for expansion and upcoming study data.
Despite challenges like a negative CHMP opinion and safety concerns, opportunities in education, expansion, and market penetration are on the horizon.
The company's commitment to shareholder value, financial stability, and milestone achievements sets a positive outlook for the future.

Apellis Pharma reports robust Q2 earnings, eyes market expansion

Apellis Pharma's Q2 performance reflects strong revenue growth and market leadership, supported by successful product sales and strategic initiatives.
While facing competition and challenges in market share retention, the company's focus on expansion and financial strength bode well for future growth.
Opportunities in new indications, market expansion, and pipeline development position Apellis Pharma for continued value creation for patients and shareholders.

Apellis Pharma reports robust Q3 performance amidst market challenges

Apellis Pharma's Q3 performance reflects strong demand for SYFOVRE and strategic initiatives to drive market share.
While facing challenges such as gross to net adjustments and market dynamics, the company remains optimistic about future growth opportunities.
By leveraging strengths in product efficacy and real-world data, Apellis Pharma aims to expand globally and enhance profitability.

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Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutic compounds to treat diseases with high unmet needs. Its products include EMPAVELI and SYFOVRE. The company was founded by Candace Rose Depp, Pascal Deschatelets, Cedric Francois, and Alec Machiels on September 25, 2009 and is headquartered in Waltham, MA.

WALTHAM, Mass. and STOCKHOLM, March 17, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced that the New England Journal of Medicine (NEJM) published results from the Phase 3 PEGASUS study, which demonstrated the superiority of pegcetacoplan, an investigational targeted C3 therapy, in improving hemoglobin levels and showed improvements in key clinical outcomes compared to eculizumab, a C5 inhibitor, in adults with paroxysmal nocturnal hemoglobinuria (PNH) at 16 weeks who had persistent anemia following treatment with eculizumab.

Apellis and Sobi: The New England Journal of Medicine Publishes Phase 3 PEGASUS Study Results Comparing Pegcetacoplan to Eculizumab for PNH

WALTHAM, Mass., March 10, 2021 (GLOBE NEWSWIRE) --   Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that two leading journals, Ophthalmology and the American Journal of Ophthalmology, published post hoc analyses from the Phase 2 FILLY study of intravitreal pegcetacoplan for geographic atrophy (GA) secondary to AMD. GA is a leading cause of blindness that affects approximately five million people around the world1,2 and has no approved treatments.

Apellis Announces Two New Publications from the Positive Phase 2 FILLY Study Evaluating Pegcetacoplan in Geographic Atrophy

Following an interim review of mortality data by an independent data monitoring committee (DMC), Apellis Pharmaceuticals Inc (NASDAQ: APLS) will not pursue additional development of APL-9 for the treatment of severe COVID-19. DMC reviewed data from the Phase 1/2 study of APL-9 found no meaningful reduction in the overall mortality rate in APL-9 combined with the standard of care arm, compared to standard of care alone.

Apellis Pharmaceuticals To Stop Testing APL-9 In Severe COVID-19 Patients

WALTHAM, Mass., March 04, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1/2 study by an independent data monitoring committee (DMC), which found no meaningful reduction in the overall mortality rate in patients treated with APL-9 in combination with standard of care therapy compared to standard of care alone. No safety signals were observed by the DMC.

Apellis Provides Update on APL-9 for Severe COVID-19

Apellis Pharmaceuticals, Inc. (APLS) CEO Cedric Francois on Q4 2020 Results - Earnings Call Transcript

Apellis' (APLS) bottom line grows year over year in the fourth quarter of 2020 while revenues beat estimates. Main focus of the company is on lead pipeline candidate, pegcetacoplan.

Apellis' (APLS) Q4 Earnings Rise Y/Y, Pegcetacoplan in Focus

Apellis Pharmaceuticals, Inc. (APLS) delivered earnings and revenue surprises of 293.75% and 35.47%, respectively, for the quarter ended December 2020. Do the numbers hold clues to what lies ahead for the stock?

Apellis Pharmaceuticals, Inc. (APLS) Tops Q4 Earnings and Revenue Estimates

WALTHAM, Mass., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will host a conference call and webcast to discuss its fourth quarter and full year 2020 financial results on Thursday, February 25, 2021 at 4:30 p.m. ET.

Apellis Pharmaceuticals to Hold Fourth Quarter and Full Year 2020 Earnings Conference Call on February 25, 2021

Apellis Pharmaceuticals is gearing up for potential approval of its PNH drug pegcetacoplan; the PDUFA date has been established for May 14, 2021. Pegcetacoplan achieved superior increase in hemoglobin levels in a head to heady study against Soliris. Upon FDA approval, pegcetacoplan may be used as alternative to Soliris and Ultomiris.

Apellis Is A Long-Term Name To Own Based On PNH Data Alone

WALTHAM, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced the closing of its previously announced privately negotiated exchange transactions (the “Exchange Transactions”) with certain holders of its 3.500% Convertible Senior Notes due 2026 issued in September 2019 (the “Notes”). In the Exchange Transactions, the holders exchanged approximately $126.1 million in aggregate principal amount of Notes and Apellis issued an aggregate of 3,906,869 shares of its common stock.

Apellis Announces Closing of Previously Announced Exchanges of Approximately $126.1 Million in Principal Amount of Its 3.500% Convertible Senior Notes Due 2026 for Common Stock

WALTHAM, Mass., Jan. 21, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will host a virtual investor event titled Pegcetacoplan: Advancing the First Potential Treatment for Geographic Atrophy (GA) from 10:00 a.m. to noon ET on January 28, 2021. The virtual meeting will focus on the significant unmet need in GA and the company's intravitreal pegcetacoplan program, which is on track for Phase 3 GA results in the third quarter of 2021.

Apellis Pharmaceuticals to Host Investor Event on Geographic Atrophy on January 28, 2021

WALTHAM, Mass., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that it has entered into separate, privately negotiated exchange agreements with certain holders of its 3.500% Convertible Senior Notes due 2026 issued in September 2019 (the “Notes”). Under the terms of these exchange agreements, the holders have agreed to exchange with Apellis approximately $107.5 million in aggregate principal amount of Notes held by them for (i) 2,232,808 shares of Apellis' common stock, which is equal to 20.7792 shares per $1,000 principal amount of Notes exchanged plus (ii) an additional number of shares of Apellis' common stock per $1,000 principal amount of Notes exchanged equal to the quotient of (a) $544.07 divided by (b) the average of the daily volume-weighted average prices of Apellis' common stock over the ten consecutive trading days commencing on January 7, 2021. The exchange transactions are expected to close on January 25, 2021, subject to the satisfaction of customary closing conditions.

Apellis Announces Agreements to Exchange Approximately $107.5 Million in Principal Amount of Its 3.500% Convertible Senior Notes Due 2026 for Common Stock

Apellis' (APLS) lead pipeline candidate, pegcetacoplan, is a promising one and being developed for several indications.

Apellis' (APLS) Pipeline Candidate Pegcetacoplan Promising

STOCKHOLM and WALTHAM, Mass., Dec. 10, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals Inc. (Nasdaq: APLS) today announced positive top-line results at week 48 from the phase 3 PEGASUS study, which demonstrated sustained...

Sobi and Apellis report positive top-line results at 48 weeks from the phase 3 PEGASUS study of pegcetacoplan in PNH

WALTHAM, Mass. and STOCKHOLM, Sweden, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi™ Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced positive top-line results at Week 48 from the Phase 3 PEGASUS study, which demonstrated sustained hematological and clinical improvements in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were treated with pegcetacoplan, an investigational, targeted C3 therapy. The safety profile of pegcetacoplan was consistent with previously reported data, and no new safety signals were identified.

Apellis and Sobi Report Positive Top-line Results at 48 Weeks from the Phase 3 PEGASUS Study of Pegcetacoplan in PNH

WALTHAM, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will present at the 2020 Evercore ISI HealthCONx Conference on Thursday, December 3, 2020 at 1:25 p.m. ET. The conference will be held in a virtual meeting format.

Apellis Pharmaceuticals to Present at the 2020 Evercore ISI HealthCONx Conference

Apellis (APLS) and Sobi dose the first patient in the mid-stage MERIDIAN study, which is investigating pegcetacoplan to address adults with sporadic amyotrophic lateral sclerosis.

Apellis (APLS) Begins Dosing With Pegcetacoplan in ALS Study

STOCKHOLM and WALTHAM, Mass., Nov. 19, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the first patient has been dosed in the potentially registrational phase 2 MERIDIAN study of...

Sobi and Apellis announce first patient dosed in potentially registrational ALS study of pegcetacoplan

WALTHAM, Mass. and STOCKHOLM, Sweden, Nov. 19, 2020 (GLOBE NEWSWIRE) --  Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced that the first patient has been dosed in the potentially registrational Phase 2 MERIDIAN study of pegcetacoplan, a targeted C3 therapy, in approximately 200 adults with sporadic amyotrophic lateral sclerosis (ALS).

Apellis and Sobi Announce First Patient Dosed in Potentially Registrational ALS Study of Pegcetacoplan

The FDA accepts Apeliis' (APLS) NDA for pegcetacoplanand and grants priority review for the treatment of paroxysmal nocturnal hemoglobinuria.

Apellis' (APLS) Blood Disorder Drug Gets FDA's Priority Tag

WALTHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the New Drug Application (NDA) for pegcetacoplan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The Prescription Drug User Fee Act (PDUFA) target action date is May 14, 2021. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH

WALTHAM, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced findings from the largest retrospective database study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analysis of the American Academy of Ophthalmology (AAO) IRIS® (Intelligent Research in Sight) Registry, the nation's first comprehensive clinical registry for eye disease, was conducted in partnership with Verana Health, the world's leading data analysis group in retinal diseases. The study highlights the significant impact of GA progression on vision, underscoring the high unmet need for GA treatment in clinical practice. The data were presented today in a late-breaking oral session as part of the Retina Subspecialty Day at AAO 2020 Virtual.

Apellis Announces Late-Breaking Presentation of Largest Retrospective Database Study in Geographic Atrophy (GA) at AAO 2020 Virtual

WALTHAM, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that eight abstracts were accepted for presentation at the virtual American Society of Hematology (ASH) Annual Meeting to be held December 5-8, 2020. Data support the positive efficacy and safety of pegcetacoplan, a targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Apellis to Present New Data Supporting the Efficacy and Safety of Pegcetacoplan in PNH at the American Society of Hematology Annual Meeting

Apellis (APLS) reports a wider-than-expected loss in the third quarter of 2020.

Apellis Pharmaceuticals' (APLS) Q3 Loss Wider Than Expected

WALTHAM, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced its third quarter 2020 financial results and business highlights.

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