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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 (Nasdaq: APLS) will host a Research and Development Day on June 30, 2021, from 12:30 p.m. to 4:30 p.m. ET in New York City and online. The event will showcase the company’s expanding pipeline in rare diseases, ophthalmology, and neurology. Key opinion leaders from top institutions will participate, including experts from Fondazione IRCCS and the Montreal Neurological Institute. A live webcast and presentation will be available on Apellis’ website, with a replay accessible for 90 days post-event.

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Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in two upcoming investor conferences. The Goldman Sachs Healthcare Conference will feature a fireside chat on June 10, 2021 at 8:00 a.m. ET, while the Bank of America Napa Biopharma Conference is set for June 16, 2021 at 4:30 p.m. ET. Both events will be available via live webcast and can be accessed from the company’s investors and media page. Replays will be accessible for 90 days post-event.

Apellis focuses on pioneering targeted C3 therapies for various diseases.

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Apellis Pharmaceuticals (APLS) reported positive results from the Phase 3 PRINCE study of EMPAVELI™ (pegcetacoplan) for treating paroxysmal nocturnal hemoglobinuria (PNH) in treatment-naïve adults. The study showed statistical superiority in hemoglobin stabilization (86% vs. 0%, p<0.0001) and significant reduction in lactate dehydrogenase (90% decrease) compared to standard care. Mean hemoglobin levels rose from 9.4 to 12.1 g/dL in the EMPAVELI group. Additionally, 91% of EMPAVELI patients remained transfusion-free. The safety profile was consistent with previous studies, with serious adverse events being lower than standard care.

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Apellis Pharmaceuticals announced FDA approval of EMPAVELI™ (pegcetacoplan), a groundbreaking targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). This therapy is approved for treatment-naïve patients and those switching from C5 inhibitors like Soliris® and Ultomiris®. In the pivotal Phase 3 PEGASUS study, EMPAVELI demonstrated superiority over Soliris in increasing hemoglobin levels and a significant 85% of EMPAVELI patients were transfusion-free at Week 16. However, EMPAVELI carries a boxed warning for serious infections, necessitating vaccinations before treatment.

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Apellis Pharmaceuticals (Nasdaq: APLS) announced the acceptance of seven abstracts for the European Hematology Association (EHA) Virtual Congress from June 9-17, 2021, showcasing the potential of pegcetacoplan, a targeted C3 therapy, for paroxysmal nocturnal hemoglobinuria (PNH). An oral presentation and e-posters emphasize pegcetacoplan's efficacy and safety. The FDA has set a target action date of May 14, 2021, for its marketing application.

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Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to two new employees on May 3, 2021. The grant includes options for 13,200 shares at an exercise price of $50.20 and 7,100 restricted stock units (RSUs). The equity awards aim to incentivize new hires as part of the company's 2020 Inducement Stock Incentive Plan. Shares from the options will vest over four years, while RSUs will vest 25% annually. This move is compliant with Nasdaq Listing Rule 5635(c)(4).

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Apellis Pharmaceuticals (APLS) announced its Q1 2021 financial results and key business developments. The FDA's review of pegcetacoplan for paroxysmal nocturnal hemoglobinuria (PNH) is ongoing, with a target action date of May 14, 2021. The company expects top-line results from the Phase 3 PRINCE study and GA studies in Q2 and Q3 2021, respectively. Cash reserves stand at $723.7 million, ensuring operational runway into late 2022. However, the company reported a Q1 net loss of $183.7 million, up from $168.8 million in 2020, driven by rising R&D and administrative expenses.

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Apellis Pharmaceuticals (APLS) will hold a conference call on April 28, 2021, at 4:30 p.m. ET to discuss its Q1 2021 financial results. Investors can join the call by dialing (866) 774-0323 for domestic calls or (602) 563-8683 for international calls, entering conference ID # 7883183. The event can also be accessed via webcast from the company’s website. Apellis is focused on developing targeted C3 therapies for various diseases driven by excessive activation of the complement cascade.

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Apellis Pharmaceuticals (APLS) announced the acceptance of 10 abstracts for presentation at the ARVO Annual Meeting from May 1-7, 2021. Key highlights include five oral presentations showcasing the potential of pegcetacoplan, an investigational C3 therapy, targeting geographic atrophy (GA). The presentations emphasize AI analytics for monitoring GA lesions and new safety and efficacy data from the Phase 2 FILLY study. Pegcetacoplan has received Fast Track designation for GA and is being evaluated across various clinical studies.

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Apellis Pharmaceuticals (APLS) announced promising results from the Phase 1b APL2-103 study of pegcetacoplan, showing a 46% reduction in mean lesion growth in patients with geographic atrophy after 24 months (p=0.007). The study involved 12 patients, and data from eight patients demonstrated significant efficacy compared to untreated eyes. No significant inflammation was reported, with only 16% developing new onset exudation. The company expects top-line results from pivotal Phase 3 DERBY and OAKS studies in Q3 2021 and plans to invite participants from the 1b study to a long-term extension study.

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FAQ

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

The current stock price of Apellis Pharmaceuticals (APLS) is $33.21 as of December 20, 2024.

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

The market cap of Apellis Pharmaceuticals (APLS) is approximately 4.1B.

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

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4.12B
105.50M
13.98%
99.97%
18.64%
Biotechnology
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