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Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Welcome to our dedicated page for Apellis Pharmaceuticals news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmaceuticals stock.

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) is a commercial-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutic compounds. The company's primary focus is on treating diseases with high unmet medical needs through the inhibition of the complement system, a crucial part of the immune system. Apellis targets the complement system at the level of C3, aiming to provide comprehensive disease control.

Apellis's flagship products include SYFOVRE® (pegcetacoplan injection) and EMPAVELI® (pegcetacoplan). SYFOVRE is the first-ever approved therapy for geographic atrophy (GA), a leading cause of blindness, while EMPAVELI is approved for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare hematological disease. Both medicines reflect the company's innovative approach to complement immunotherapy.

In 2023, Apellis achieved significant milestones, including generating $397 million in revenue, with substantial contributions from SYFOVRE and EMPAVELI. The company has also presented positive data from its Phase 2 NOBLE study for systemic pegcetacoplan in rare kidney diseases at the European Renal Association Congress, highlighting the potential of pegcetacoplan to address complex medical conditions.

Looking ahead, Apellis anticipates regulatory developments, including the European Medicines Agency’s (EMA) review of the marketing authorization application (MAA) for SYFOVRE and the expected topline data from the Phase 3 VALIANT study of systemic pegcetacoplan in mid-2024. Financially robust, Apellis recently closed a $375 million funding deal with Sixth Street to buy out existing liabilities, significantly improving its liquidity profile and positioning the company for sustainable growth.

Apellis's commitment to advancing science is evident through its extensive pipeline and collaborations, such as its partnership with Sobi for systemic pegcetacoplan. The company's approach combines bold scientific endeavors with compassionate patient care, continually striving to bring life-changing therapies to those in need.

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Apellis Pharmaceuticals, Inc. (APLS) will participate in upcoming investor conferences in March 2024, including TD Cowen 44th Annual Healthcare Conference and Raymond James & Associates’ 45th Annual Institutional Investors Conference. The company will host fireside chats and panel discussions, with live webcasts available on their website.
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Apellis Pharmaceuticals, Inc. (APLS) schedules a conference call to discuss its fourth quarter and full year 2023 financial results on February 27, 2024. Investors can access the call via phone or live webcast.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) granted equity awards to 4 new employees outside of the 2017 Stock Incentive Plan. Each employee received 6,265 restricted stock units (RSUs) that will vest annually over four years, subject to continued employment.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) received a negative opinion from the CHMP of the European Medicines Agency on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. The company plans to seek immediate re-examination of its application. The MAA is based on results from the Phase 3 OAKS and DERBY studies at 24 months, which showed promising treatment effects over time and a well-demonstrated safety profile. However, the negative opinion is disappointing for the millions of Europeans living with GA, a progressive and irreversible form of vision loss.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) reports approximately $138 million in preliminary U.S. net product revenues for the fourth quarter of 2023, with strong sales of SYFOVRE® and EMPAVELI®. SYFOVRE® garnered approximately $114 million, and EMPAVELI® contributed approximately $24 million. The company also highlighted high patient compliance rates and increased use of the EMPAVELI Injector. These results were presented at the 42nd Annual J.P. Morgan Healthcare Conference.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) approved the grant of equity awards to 2 new employees as equity inducement awards outside of the company's 2017 Stock Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). Each employee received 1,960 restricted stock units (RSUs) that will vest annually over a 4-year period, subject to continued employment.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) to present at 42nd Annual J.P. Morgan Healthcare Conference
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) will host a fireside chat at the Goldman Sachs Healthcare C-Suite Unscripted Conference on January 4, 2023, at 2:25 p.m. ET. The event will be available via a live webcast and a replay will be available for approximately 90 days.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) received a negative trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its marketing authorization application (MAA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company plans to appeal the outcome and seek re-examination of the opinion after the CHMP adopts a negative opinion at its next meeting in January 2024. The MAA is based on results from the Phase 3 OAKS and DERBY studies at 24 months, which showed promising treatment effects and a well-demonstrated safety profile. However, the negative trend vote has led to disappointment among company executives and the retina community.
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Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi presented post hoc data at the American Society of Hematology (ASH) Annual Meeting, reinforcing the long-term efficacy and safety of EMPAVELI® (pegcetacoplan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) for up to three years. Key markers of disease rapidly improved and were sustained, with the majority of patients remaining transfusion free over the long term. No cases of meningococcal infection were observed over three years in the analysis.
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FAQ

What is the current stock price of Apellis Pharmaceuticals (APLS)?

The current stock price of Apellis Pharmaceuticals (APLS) is $30.77 as of November 22, 2024.

What is the market cap of Apellis Pharmaceuticals (APLS)?

The market cap of Apellis Pharmaceuticals (APLS) is approximately 3.7B.

What does Apellis Pharmaceuticals, Inc. specialize in?

Apellis specializes in the discovery, development, and commercialization of novel therapeutic compounds aimed at treating diseases with high unmet medical needs through the inhibition of the complement system.

What are Apellis's primary products?

Apellis's primary products are SYFOVRE® (pegcetacoplan injection) for geographic atrophy and EMPAVELI® (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH).

How did Apellis perform financially in 2023?

In 2023, Apellis generated $397 million in revenue, with significant contributions from SYFOVRE and EMPAVELI.

What is SYFOVRE® approved for?

SYFOVRE® is approved for the treatment of geographic atrophy (GA), a leading cause of blindness related to age-related macular degeneration.

What is EMPAVELI® approved for?

EMPAVELI® is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally.

What recent clinical data has Apellis presented?

Apellis recently presented positive data from its Phase 2 NOBLE study for systemic pegcetacoplan in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) at the European Renal Association Congress.

What is the latest financial development for Apellis?

Apellis recently closed a $375 million funding deal with Sixth Street to buy out existing SFJ Pharmaceuticals development liabilities, significantly improving its liquidity profile.

What are Apellis's expectations for 2024?

In 2024, Apellis anticipates regulatory developments from EMA and expects topline data from the Phase 3 VALIANT study for systemic pegcetacoplan in mid-2024.

Who is Apellis collaborating with for systemic pegcetacoplan?

Apellis is collaborating with Sobi for the global co-development and commercialization of systemic pegcetacoplan.

How is Apellis combining science and patient care?

Apellis combines bold scientific endeavors with compassionate patient care, striving to bring life-changing therapies to patients with serious diseases.

Apellis Pharmaceuticals, Inc.

Nasdaq:APLS

APLS Rankings

APLS Stock Data

3.66B
105.50M
13.98%
97.43%
16.71%
Biotechnology
Pharmaceutical Preparations
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United States of America
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