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) has granted equity inducement awards to four new employees effective December 2, 2024. The awards, approved under Nasdaq Listing Rule 5635(c)(4), include:
- Options to purchase 27,445 shares at $35.42 per share (closing price on grant date)
- 28,630 restricted stock units (RSUs)
The stock options will vest 25% after one year, followed by monthly vesting of 1/48th of shares over four years. RSUs will vest 25% annually over four years. All vestings are subject to continued employment.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in two major investor conferences in December 2024. The company will present at the Evercore ISI HealthCONx Conference on December 4 at 9:10 a.m. ET and the Citi Global Healthcare Conference on December 5 at 1:00 p.m. ET. Both fireside chat sessions will be available via webcast on the company's website under the 'Events and Presentations' page, with replays accessible for approximately 90 days after the events.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in the Jefferies London Healthcare Conference. The company will host a fireside chat on Tuesday, November 19, 2024, at 8:30 a.m. GMT. The event will be accessible through a live webcast on the company's website under the 'Events and Presentations' page in the 'Investors and Media' section. Interested parties can access a replay of the webcast, which will remain available for approximately 90 days after the event.
Apellis Pharmaceuticals reported Q3 2024 financial results with total revenue of $196.8 million, including $176.6 million in U.S. net product sales. SYFOVRE demand grew 7% quarter-over-quarter, generating $152.0 million in U.S. net product revenue, though sales were impacted by higher gross-to-net adjustments. EMPAVELI contributed $24.6 million in U.S. net product revenue. The company reported a net loss of $57.4 million and held cash and equivalents of $396.9 million as of September 30, 2024. Following FDA feedback, Apellis plans to file an sNDA for pegcetacoplan in C3G/IC-MPGN in early 2025.
Apellis Pharmaceuticals (APLS) announced positive Phase 3 VALIANT study results for pegcetacoplan in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study demonstrated a statistically significant 68% proteinuria reduction compared to placebo. Key secondary endpoints showed pegcetacoplan stabilized kidney function (eGFR) with a +6.3mL/min/1.73m2 difference over placebo, and 71% of treated patients achieved complete clearance of C3c deposits. The treatment demonstrated a favorable safety profile, with similar adverse event rates between treatment and placebo groups. Apellis plans FDA submission in early 2025.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced it will host a conference call and webcast on November 5, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results. Interested parties can pre-register for the call, and a live audio webcast with accompanying slides will be accessible through the company's website. A replay of the webcast will be available for 90 days following the event.
Apellis is a global biopharmaceutical company focused on developing life-changing therapies for challenging diseases. They have introduced the first new class of complement medicine in 15 years and currently 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 the potential of targeting C3 across various retinal, rare, and neurological diseases.
Apellis Pharmaceuticals (Nasdaq: APLS) announced that the abstract of the Phase 3 VALIANT study of pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) was accepted for oral presentation at the American Society of Nephrology (ASN) Kidney Week. The presentation will take place on October 26 at 11:00 a.m. PT in San Diego, CA.
Following the presentation, Apellis will host a webinar at 12:30 p.m. PT to discuss the detailed VALIANT results. Two additional abstracts on pegcetacoplan in C3G and primary IC-MPGN were accepted as poster presentations, focusing on post-transplant recurrent cases and long-term safety and efficacy.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced the approval of equity awards for one new employee, effective October 1, 2024. These awards, granted outside the company's 2017 Stock Incentive Plan but under the 2020 Inducement Stock Incentive Plan, are in compliance with Nasdaq Listing Rule 5635(c)(4). The employee received 4,240 restricted stock units (RSUs). The vesting schedule for these RSUs is as follows:
- 25% of the shares will vest on the first anniversary of the grant date
- An additional 25% will vest annually thereafter
Vesting is subject to the employee's continued employment on each vesting date. These equity awards are considered material to the employee's acceptance of employment with Apellis Pharmaceuticals.
Apellis Pharmaceuticals (Nasdaq: APLS) has announced its participation in the UBS Virtual Ophthalmology Day. The company will host a fireside chat on Wednesday, October 2, 2024, at 8:30 a.m. ET. This event will be accessible through a live webcast on the company's website, specifically on the "Events and Presentations" page within the "Investors and Media" section.
For those unable to attend the live event, Apellis will provide a replay of the webcast, which will remain available for approximately 90 days following the event. This virtual participation underscores Apellis' commitment to engaging with investors and industry professionals in the ophthalmology sector.
Apellis Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration in the EU.
The company expressed disappointment with the decision, which leaves millions of Europeans with GA without a treatment option. Despite support from the European retina community and dissenting votes from some CHMP members, the negative opinion was upheld. Apellis remains committed to expanding access to pegcetacoplan in other regions globally, focusing on unmet patient needs in the U.S. and elsewhere.
GA is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, affecting over five million people globally. Pegcetacoplan is approved in the United States under the brand name SYFOVRE® for the treatment of GA secondary to age-related macular degeneration.
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