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About Apellis Pharmaceuticals (Nasdaq: APLS)
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company at the forefront of developing innovative therapies that target the complement system, a critical component of the immune system. With a pioneering focus on C3 inhibition, Apellis aims to address significant unmet medical needs in serious and often life-altering diseases. The company’s mission is rooted in advancing science with compassion to deliver life-changing treatments for patients worldwide.
Core Products and Therapeutic Focus
Apellis has commercialized two groundbreaking therapies:
- SYFOVRE® (pegcetacoplan injection): The first-ever approved treatment for geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness globally. By targeting the C3 protein, SYFOVRE slows the progression of GA, offering hope to millions of patients suffering from this irreversible condition.
- EMPAVELI® (pegcetacoplan): A targeted C3 therapy approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder. EMPAVELI is also under investigation for rare kidney diseases such as C3 glomerulopathy (C3G) and immune-complex membranoproliferative glomerulonephritis (IC-MPGN), which currently lack approved treatments.
Innovative Science and Market Position
Apellis is a trailblazer in complement medicine, introducing the first new class of complement-targeting therapies in over 15 years. By focusing on C3, the central protein in the complement cascade, the company’s therapies offer comprehensive control of immune system dysregulation, addressing the root cause of various diseases. This strategic approach positions Apellis as a leader in the biopharmaceutical industry, with a robust pipeline targeting retinal, rare, and neurological diseases.
Global Reach and Strategic Vision
Headquartered in Waltham, Massachusetts, Apellis operates on a global scale, with regulatory approvals in the United States, European Union, and Australia. The company’s commitment to innovation is reflected in its ongoing clinical trials and collaborative partnerships aimed at expanding the therapeutic potential of its products. With a strong financial foundation and a focus on long-term growth, Apellis continues to build on its leadership in complement medicine.
Commitment to Patients and Future Growth
Apellis combines scientific rigor with a patient-first philosophy, striving to improve the quality of life for those affected by challenging diseases. The company’s dedication to addressing high unmet medical needs, coupled with its innovative pipeline and commercial success, underscores its potential for sustained growth and impact in the biopharmaceutical industry.
Competitive Landscape
In the competitive field of complement therapeutics, Apellis stands out for its unique focus on C3 inhibition. While competitors like Alexion Pharmaceuticals (AstraZeneca) target other components of the complement cascade, Apellis’s approach offers a broader and potentially more effective mechanism of action. This differentiation, along with its strong clinical data and patient-centric approach, solidifies its position as a leader in the space.
Apellis Pharmaceuticals (Nasdaq: APLS) announced it received formal FDA feedback supporting its plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan aimed at treating geographic atrophy (GA) due to age-related macular degeneration. The NDA will utilize data from the Phase 3 DERBY and OAKS studies, alongside the Phase 2 FILLY study, all deemed adequate by the FDA. Apellis aims to submit the NDA in H1 2022 without needing additional trials. Over 1,500 patients participated in these studies, highlighting the company's commitment to addressing GA, a leading cause of blindness.
Apellis Pharmaceuticals (APLS) announced the presentation of Phase 3 DERBY and OAKS trial data for pegcetacoplan at the AAO Annual Meeting from Nov 12-15, 2021. Pegcetacoplan, an investigational C3 therapy, demonstrated clinically meaningful reductions in geographic atrophy (GA) lesion growth in patients with age-related macular degeneration. While achieving the primary endpoint in OAKS, it narrowly missed in DERBY. The company plans to file a New Drug Application with the FDA in the first half of 2022, marking a significant step toward addressing a condition with no approved treatments worldwide.
Apellis Pharmaceuticals reported $5.3 million in net product revenues from EMPAVELI in Q3 2021, contributing to total revenues of $5.7 million. The company received a positive opinion from the CHMP for pegcetacoplan in PNH and anticipates a decision by the European Commission by year-end. Apellis is on track to submit a New Drug Application for pegcetacoplan for geographic atrophy by mid-2022, with promising trial results indicating significant GA lesion growth reduction. However, net loss increased to $195.6 million, up from $135.7 million a year prior.
Apellis Pharmaceuticals announced the acceptance of five abstracts for the upcoming American Society of Hematology (ASH) Annual Meeting, including the positive Phase 3 PRINCE study of EMPAVELI in treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). Results indicated EMPAVELI’s superiority in hemoglobin stabilization and LDH reduction at Week 26 compared to standard care. The study assessed 53 adults, showcasing EMPAVELI's potential to enhance treatment for all PNH patients, regardless of prior hemoglobin levels. The oral presentation is scheduled for December 13, 2021.
Apellis Pharmaceuticals (Nasdaq: APLS) is set to participate in two major investor conferences in November 2021. The company will hold a fireside chat at the Credit Suisse 30th Annual Healthcare Conference on November 10 at 4:20 p.m. ET and a formal presentation at the Stifel Healthcare Conference on November 15 at 4:00 p.m. ET. Both events will be accessible via live webcast on the company’s website, with replays available for 90 days post-event. Apellis is a leader in targeted C3 therapies aimed at treating various serious diseases.
Apellis Pharmaceuticals (APLS) has announced a conference call and webcast set for November 8, 2021, at 4:30 p.m. ET to discuss its third quarter 2021 financial results. Interested participants can register for the call via a provided link, with conference ID 1931859. The event will also be accessible through a live audio webcast on the company’s website, with a replay available for 90 days afterward. Apellis is known for its commitment to developing targeted C3 therapies aimed at debilitating diseases across multiple medical fields, including hematology and ophthalmology.
Apellis Pharmaceuticals (APLS) and Sobi have announced a positive opinion from the European Medicines Agency's CHMP for Aspaveli® (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after at least three months on a C5 inhibitor. This recommendation is now forwarded to the European Commission for review. Aspaveli aims to provide a new treatment option for the approximately 72% of patients still anemic after C5 therapy. This follows recent U.S. approval for the same indication, which could significantly impact treatment paradigms for PNH in Europe.
Apellis Pharmaceuticals (APLS) announced the grant of equity awards to three new employees, effective October 1, 2021. The awards include options for 32,000 shares and 1,000 restricted stock units (RSUs), with an exercise price of $33.59, matching the stock's closing price on the grant date. The options will vest over four years, while the RSUs will vest 25% annually. This action, aligned with Nasdaq Listing Rule 5635(c)(4), is a strategic move to attract talent critical for the company's growth in targeted C3 therapies.
Apellis Pharmaceuticals (APLS) presented Phase 3 study results for pegcetacoplan, a targeted C3 therapy, at the Retina Society Annual Scientific Meeting. The OAKS trial showed significant reduction in geographic atrophy (GA) lesion growth with monthly (p=0.0003) and every-other-month (p=0.0052) treatments. The DERBY trial showed a reduction in lesion growth but narrowly missed the primary endpoint. Pegcetacoplan could become the first treatment for GA, which affects over five million globally. An NDA is planned for submission in H1 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference, scheduled for September 27, 2021, at 8:40 a.m. ET. The conference will be conducted virtually and accessible via a live webcast on the company’s website. A replay will be available for 90 days post-event. Apellis, a leader in targeted C3 therapies, focuses on transformative solutions for diseases caused by complement cascade activation.
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