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.
Apellis Pharmaceuticals (Nasdaq: APLS) and Sobi announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study met its primary endpoint, showing a statistically significant 68% reduction in proteinuria compared to placebo at Week 26. Results were consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.
Pegcetacoplan also demonstrated significance on key secondary endpoints and favorable safety. Apellis plans to submit a supplemental new drug application to the FDA in early 2025, while Sobi plans to submit a marketing application with the EMA in 2025.
Apellis Pharmaceuticals (Nasdaq: APLS), a global biopharmaceutical company specializing in complement therapies, has announced the approval of equity inducement awards for one new employee. The grants, made outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, were approved on August 1, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4).
The employee received 1,015 restricted stock units (RSUs). These RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date and an additional 25% vesting annually thereafter, contingent on the employee's continued employment.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its Q2 2024 financial results, generating $199.7 million in revenue, a significant increase from $95 million in Q2 2023. U.S. net product sales included $154.6 million from SYFOVRE and $24.5 million from EMPAVELI. Cost of sales rose to $23.1 million, while R&D expenses decreased to $78 million. SG&A expenses increased to $128.1 million. Net loss narrowed to $37.7 million from $122 million in Q2 2023. The company holds $360.1 million in cash and anticipates reaching positive cash flow.
Notable milestones include the re-examination of SYFOVRE's marketing application by the EMA, expected by Q4 2024, and upcoming Phase 3 trial data for systemic pegcetacoplan in C3G/IC-MPGN in August 2024. SYFOVRE remains market leader in GA with over 84,000 doses delivered in Q2 2024. EMPAVELI shows high patient compliance at 97%.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced a conference call and webcast to discuss its second quarter 2024 financial results on August 1, 2024, at 8:30 a.m. ET. Investors can pre-register for the call, and a live audio webcast with accompanying slides will be available on the company's website. A replay will be accessible for 90 days following the event.
Apellis is a global biopharmaceutical company focused on developing therapies for challenging diseases. They have introduced the first new class of complement medicine in 15 years and have two approved medicines targeting C3, including the first-ever therapy for geographic atrophy, a leading cause of blindness worldwide. The company aims to further explore C3 targeting across retinal, rare, and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that five oral presentations and one abstract featuring their product SYFOVRE® (pegcetacoplan injection) will be showcased at the ASRS Annual Scientific Meeting from July 17-20, 2024, in Stockholm. SYFOVRE has shown efficacy and safety in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Results from the GALE study highlighted significant visual function benefits after 36 months of continuous treatment. Other presentations will discuss comparisons with other treatments, AI analysis in therapy, and unique case studies. SYFOVRE is notable for its ability to slow disease progression and is currently approved in the US for AMD-related GA. Common adverse reactions include ocular discomfort and neovascular AMD.
On June 28, 2024, Apellis Pharmaceuticals (Nasdaq: APLS) announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the marketing authorization application for pegcetacoplan, a treatment for geographic atrophy (GA). Despite this, Apellis plans to seek a re-examination with a final decision expected in Q4 2024. The expert group confirmed that GA lesion size is a suitable trial outcome measure and microperimetry is the best functional measure. Pegcetacoplan is already approved in the US for GA secondary to age-related macular degeneration. GA affects over 5 million people globally and leads to irreversible vision loss.
Apellis Pharmaceuticals announced that their SYFOVRE® (pegcetacoplan injection) has shown to preserve visual function for 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), as revealed in the GALE long-term extension study.
The findings were presented at the Clinical Trials at the Summit Meeting. SYFOVRE is the only approved GA treatment to show a visual function benefit in a prespecified endpoint, reducing the development of new scotomatous points compared to a sham crossover group.
The GALE study, consisting of 792 participants, evaluates the long-term efficacy and safety of SYFOVRE. The Phase 3 OAKS and DERBY studies supporting these results showed that both monthly and every-other-month doses reduced GA lesion growth and maintained a favorable safety profile.
However, SYFOVRE is associated with risks such as endophthalmitis, retinal detachments, and increased intraocular pressure.
Apellis Pharmaceuticals (Nasdaq: APLS) will host a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference.
The event is scheduled for June 12, 2024, at 4:00 p.m. ET.
A live webcast will be accessible via the company's website on the 'Events and Presentations' page under the 'Investors and Media' section.
A replay of the webcast will be available for 90 days post-event.
Apellis Pharmaceuticals and Sobi have announced positive one-year results from the Phase 2 NOBLE study on systemic pegcetacoplan for treating post-transplant recurrence of C3 glomerulopathy (C3G) and IC-MPGN. The study, presented at the ERA Congress, showed rapid reduction of disease activity at 12 weeks, sustained over a year.
Of the 11 patients treated, 55% showed zero C3c staining intensity, indicating clearance of C3c deposits, and 64% showed zero inflammation. Additionally, the treatment led to sustained improvements in proteinuria and kidney function stabilization. Pegcetacoplan was generally well-tolerated with mostly mild to moderate adverse events. The ongoing Phase 3 VALIANT study will further evaluate pegcetacoplan’s potential, with results expected later this year.
Apellis Pharmaceuticals announced a new non-dilutive senior secured credit facility with Sixth Street for up to $475 million, with $375 million received at closing. Apellis can access an additional $100 million before September 2025 under certain conditions and another $100 million through a third-party working capital facility. The majority of the proceeds will buy out a $326 million development liability to SFJ Pharmaceuticals, eliminating $366 million in payments through 2027. This improves Apellis' liquidity without needing additional capital markets funding. The credit facility matures in 2030 with a 3-month SOFR + 5.75% interest rate and is secured by Apellis' assets. As of March 31, 2024, Apellis had $325.9 million in cash and equivalents.
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