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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.
Apellis Pharmaceuticals (Nasdaq: APLS) announced a conference call and webcast to discuss its first quarter 2023 financial results scheduled for May 4, 2023, at 4:30 p.m. ET. Interested participants must pre-register for the call. The event will be accessible via the company’s website, where a replay will be available for 30 days post-event. As a leader in complement medicine, Apellis focuses on innovative therapies for serious diseases, including geographic atrophy, a major cause of blindness. With a strong pipeline of nearly a dozen clinical and pre-clinical programs, the company is committed to maximizing the potential of targeting C3. For further details, visit their official website.
Apellis Pharmaceuticals (APLS) announced positive results from the Phase 3 OAKS and DERBY studies for SYFOVRE™ (pegcetacoplan injection), the first approved treatment for geographic atrophy (GA) due to age-related macular degeneration (AMD). The analyses presented at the ARVO Annual Meeting demonstrated that SYFOVRE preserved visual function, showing a mean advantage of 5.6 letters in best corrected visual acuity compared to sham, and a 4.1-point improvement in quality-of-life scores. Additionally, SYFOVRE significantly slowed the loss of retinal cells necessary for vision, reducing photoreceptor cell loss by 46-53% and retinal pigmented epithelial cell loss by 20-27%. With marketing applications under review in multiple regions, a decision in the EU is anticipated in early 2024.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that its marketing applications for intravitreal pegcetacoplan, targeted at treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD), have been validated by regulatory bodies in Canada, Australia, the UK, and Switzerland. Decisions from these authorities are anticipated in the first half of 2024. Following its first approval in the U.S., this move marks a significant step towards worldwide access to pegcetacoplan. The applications were based on Phase 3 OAKS and DERBY study results, demonstrating meaningful reductions in GA lesion growth. Additionally, a marketing authorization application is under review by the European Medicines Agency, with an expected decision in early 2024.
Apellis Pharmaceuticals has launched the GA Won’t Wait™ campaign featuring actor Henry Winkler to raise awareness about geographic atrophy (GA), a serious form of age-related macular degeneration (AMD) affecting one million Americans. The initiative aims to educate older adults on recognizing symptoms of GA and encourage them to seek timely medical advice. Winkler draws from personal experience, having witnessed the devastating effects of AMD on his father-in-law's independence. Symptoms of GA include blurred vision and difficulty with daily tasks, emphasizing the need for early diagnosis and intervention. Apellis stresses that vision loss isn't a natural part of aging, and timely eye health discussions are crucial as individuals age. For further details, visit GAwontwait.com.
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