PDUFA target action date is July 28, 2025 WALTHAM, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI ® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative... Read More

Reported $781.4 million in full year 2024 revenues, representing 97% year-over-year growth SYFOVRE ® (pegcetacoplan injection) full year 2024 net product revenue of $611.9 million EMPAVELI ® (pegcetacoplan) full year 2024 net product revenue of $98.1 million Submitted a supplemental new drug application (sNDA) for approval of EMPAVELI for C3G and primary IC-MPGN; U.S. launch anticipated in 2H 2025, if approved On track to... Read More

WALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will present at the TD Cowen 45 th Annual Health Care Conference on Monday, March 3, 2025, at 10:30 a.m. ET. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast will be available for... Read More

WALTHAM, Mass. and STOCKHOLM, Sweden, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, chronic kidney... Read More

WALTHAM, Mass., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be... Read More

WALTHAM, Mass., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) announced today that the company approved the grant of equity awards to three new employees with a grant date of February 3, 2025, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment... Read More

WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Therapeutic Goods Administration (TGA) has approved SYFOVRE ® (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the... Read More

Reports $709 million in preliminary 1 full-year 2024 U.S. net product revenues $611 million in SYFOVRE ® U.S. net product revenues, including $167 million in 4Q 2024 $98 million in EMPAVELI ® U.S. net product revenues, including $23 million in 4Q 2024 Expects submission of EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025; U.S. launch anticipated in 2H 2025, if approved Plans initiation of Phase 3 studies of... Read More

WALTHAM, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that Keli Walbert will join the Apellis Board of Directors, effective immediately. Ms. Walbert brings more than two decades of biopharmaceutical commercial leadership experience to the Board. “We are delighted to welcome Keli to the Apellis Board of Directors,” said Cedric Francois, M.D., Ph.D., chief executive... Read More

WALTHAM, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to one new employee with a grant date of January 2, 2025, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive... Read More

WALTHAM Mass., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to four new employees with a grant date of December 2, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive... Read More

WALTHAM, Mass., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS) today announced that the company will participate in the following December investor conferences: Evercore ISI HealthCONx Conference: Fireside chat on Wednesday, December 4, 2024, at 9:10 a.m. ET Citi Global Healthcare Conference: Fireside chat on Thursday, December 5, 2024, at 1:00 p.m. ET The live conference webcasts will be... Read More

WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 19, 2024, at 8:30 a.m. GMT. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast will be... Read More

Generated $196.8 million in 3Q 2024 revenues, including $176.6 million in U.S. net product sales Grew SYFOVRE® (pegcetacoplan injection) demand by 7% quarter-over-quarter, with U.S. net product revenue of $152.0 million Increase in demand offset by higher gross-to-net adjustments in the quarter Following FDA feedback, on track to file an sNDA seeking approval of pegcetacoplan for C3G / primary IC-MPGN in early 2025 based on... Read More

Statistically significant 68% (p<0.0001) proteinuria reduction compared to placebo, with reduction observed as early as Week 4 All secondary endpoints favored treatment with pegcetacoplan, including: Stabilized eGFR, a key measure of kidney function 71% of patients achieved zero C3c staining intensity, demonstrating complete clearance of C3c deposits Results consistent across subgroups including C3G and IC-MPGN, adolescent... Read More

WALTHAM, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its third quarter 2024 financial results on Tuesday, November 5, 2024, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be accessed through... Read More

Company to host a webinar on the detailed VALIANT results at 12:30 p.m. PT on Saturday, October 26 WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today 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 as an oral presentation during the... Read More

WALTHAM, Mass., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of October 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

WALTHAM, Mass., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc . (Nasdaq: APLS) today announced that the company will host a fireside chat at the UBS Virtual Ophthalmology Day on Wednesday, October 2, 2024, at 8:30 a.m. ET. The live event webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast will be available for... Read More

WALTHAM, Mass., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its June 2024 negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. “We... Read More

WALTHAM Mass., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of September 3, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment... Read More

WALTHAM, Mass., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS) today announced that the company will participate in the following September investor conferences: Wells Fargo Annual Healthcare Conference 2024: Fireside chat on Thursday, September 5, 2024, at 9:30 a.m. ET Baird 2024 Global Healthcare Conference: Fireside chat on Wednesday, September 11, 2024, at 9:05 a.m. ET The live... Read More

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys Demonstrated favorable safety, consistent with established profile Companies plan to submit data for regulatory approval in the US... Read More

WALTHAM, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to one new employee with a grant date of August 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan)... Read More

Generated $199.7 million in 2Q 2024 revenues, including $179.1 million in U.S. net product sales $154.6 million for SYFOVRE® (pegcetacoplan injection) $24.5 million for EMPAVELI® (pegcetacoplan) Initiated a re-examination of the marketing authorization application of SYFOVRE with the European Medicines Agency (EMA); expect a final decision in 4Q 2024 Plan to report topline Phase 3 data with systemic pegcetacoplan in C3G /... Read More

WALTHAM, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its second quarter 2024 financial results on Thursday, August 1, 2024, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be accessed through... Read More

Late-breaking presentation shows SYFOVRE® (pegcetacoplan injection) demonstrated visual function benefit on prespecified endpoint in GALE long-term extension study WALTHAM, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that six abstracts, five of which are oral presentations, will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific... Read More

WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP... Read More

SYFOVRE is the only approved GA treatment to demonstrate a visual function benefit in a prespecified endpoint Data presented at the Clinical Trials at the Summit Meeting WALTHAM, Mass., June 10, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that SYFOVRE ® (pegcetacoplan injection) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related... Read More

WALTHAM, Mass., June 05, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024, at 4:00 p.m. ET. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the... Read More

Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were cleared Highlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced... Read More

Apellis received $375 million in funding at close, with ability to access an additional $100 million Majority of initial proceeds used to buy out existing SFJ Pharmaceuticals development liability Significantly improves liquidity profile by eliminating $366 million in SFJ payments through 2027 WALTHAM, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), today announced that it has entered... Read More

Generated $172.3 million in 1Q 2024 revenues, including $163.1 million in U.S. net product sales $137.5 million for SYFOVRE® (pegcetacoplan injection) $25.6 million for EMPAVELI® (pegcetacoplan) Anticipates CHMP opinion for pegcetacoplan in GA no later than July 2024 On track to report topline Phase 3 data with systemic pegcetacoplan in C3G / IC-MPGN in mid-2024 Cash and cash equivalents of $325.9 million as of March 31,... Read More

WALTHAM, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a fireside chat at the Bank of America Securities Healthcare Conference on Tuesday, May 14, 2024, at 8:00 a.m. PT. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast will... Read More

WALTHAM, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that 14 abstracts, 11 of which are oral presentations, will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 5 - 9 in Seattle. The data continue to reinforce the robust efficacy and safety profile of SYFOVRE ® (pegcetacoplan injection) for geographic... Read More

Decision by EMA follows recent judgment by the Court of Justice of the European Union regarding the organization of EMA’s expert groups Apellis anticipates a CHMP opinion no later than July 2024 WALTHAM, Mass., April 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application (MAA) for... Read More

WALTHAM, Mass., April 23, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its first quarter 2024 financial results on Tuesday, May 7, 2024, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be accessed through the... Read More

WALTHAM, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of April 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

WALTHAM, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a fireside chat at the 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 12:45 p.m. ET. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast... Read More

WALTHAM, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that leading retina specialist Philip Ferrone, M.D., will join the company as Chief Medical Retina Advisor, effective March 18. “Phil is globally renowned for his leadership in retina, including as a past president of the American Society of Retina Specialists (ASRS), so we are delighted to welcome him to the... Read More

WALTHAM, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to one new employee with a grant date of March 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

Generated $397 million in full year 2023 revenues, including $275 million for SYFOVRE ® (pegcetacoplan injection) and $91 million for EMPAVELI ® (pegcetacoplan) Strong SYFOVRE launch, with more than 160,000 total doses (commercial and samples) distributed in 2023 Topline data from Phase 3 VALIANT study of systemic pegcetacoplan in C3G and IC-MPGN expected in mid-2024 Cash and cash equivalents of $351 million as of December... Read More

WALTHAM, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS) today announced that the company will participate in the following March investor conferences: TD Cowen 44 th Annual Healthcare Conference: Fireside chat on Monday, March 4, 2024, at 2:10 p.m. ET Ophthalmology Corporate Panel Discussion on Tuesday, March 5, 2024, at 9:10 a.m. ET Raymond James & Associates’ 45th Annual... Read More

WALTHAM, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its fourth quarter and full year 2023 financial results on Tuesday, February 27, 2024, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be... Read More

WALTHAM, Mass., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to 4 new employees with a grant date of February 1, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

WALTHAM, Mass., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As previously... Read More

Approximately $114 million in preliminary fourth quarter SYFOVRE ® revenue as strong launch continues Approximately $24 million in preliminary fourth quarter EMPAVELI ® revenue WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced preliminary U.S. net product revenues of approximately $138 million for the fourth quarter and approximately $366 million for the full year... Read More

WALTHAM, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to 2 new employees with a grant date of January 2, 2024, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

WALTHAM, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will present at the 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 9:45 a.m. PT. The event will be available via a live webcast from the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the webcast will be... Read More

WALTHAM, Mass., Dec. 28, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will host a fireside chat at the Goldman Sachs Healthcare C-Suite Unscripted Conference on Thursday, January 4, 2023, at 2:25 p.m. ET. The event will be available via a live webcast from the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of... Read More

WALTHAM, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today an update on the ongoing review of its marketing authorization application (MAA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).... Read More

Rapid improvements in key markers of disease were sustained for up to three years across all adults with PNH Majority of patients remained transfusion free over the long term Zero cases of meningococcal infection observed over three years in this analysis Data shared during an oral presentation WALTHAM, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi today presented post hoc... Read More

WALTHAM Mass., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), today announced that the company approved the grant of equity awards to 4 new employees with a grant date of December 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with... Read More

WALTHAM, Mass., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), today announced that the company will host a fireside chat at the 6 th Annual Evercore ISI HealthCONx Conference on Tuesday, November 28, 2023, at 10:00 a.m. ET. The event will be available via a live webcast from the “Events and Presentations” page of the “Investors and Media” section of the company’s website . A replay of the... Read More

WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company approved the grant of equity awards to 20 new employees with a grant date of November 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment... Read More

SYFOVRE reduced nonsubfoveal GA lesion growth by over 40% (monthly) in Year 3 compared to projected sham in the GALE extension study Well-demonstrated safety profile consistent with previously reported clinical data Approximately 92% of patients enrolled in GALE completed the first year of the study, demonstrating robust long-term compliance Data were presented during an oral presentation at the American Academy of... Read More

Generated total revenues of $110.4 million in the third quarter, including $75.3 million for SYFOVRE ® (pegcetacoplan injection) and $23.9 million for EMPAVELI ® (pegcetacoplan) SYFOVRE showed continued strong demand with growth week-over-week starting in August; permanent J-code effective as of October 1 Completed corporate restructuring aimed at driving growth of SYFOVRE and EMPAVELI and strengthening operational... Read More

WALTHAM, Mass., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS) today announced that the company will host a conference call and webcast to discuss its third quarter 2023 financial results on Wednesday, November 1, 2023, at 8:00 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be accessed... Read More

SYFOVRE demonstrated clinically meaningful reductions in GA lesion growth in as few as six doses per year Only treatment approved for use beyond 12 months for GA, a chronic disease and leading cause of vision loss WALTHAM, Mass., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that The Lancet published the positive 24-month results from the Phase 3 OAKS and DERBY studies... Read More

In as early as 12 weeks: 80% of patients treated with pegcetacoplan showed a reduction in C3c staining by one or more orders of magnitude of intensity from baseline 40% of patients showed zero staining intensity, indicating that C3c deposits were cleared Pegcetacoplan-treated patients showed improvements across key clinical measures, including proteinuria, and stable kidney function No approved treatment for IC-MPGN and C3G,... Read More

WALTHAM, Mass., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to seven new employees with a grant date of October 2, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive... Read More

Continued strong demand, with more than 100,000 vials (commercial and sample) distributed to date; growth in week-over-week demand returned starting in August Permanent J-code effective as of October 1, and more than 95% of all Medicare payers now covering SYFOVRE Up to 45% reduction of nonsubfoveal GA lesion growth observed between Months 24-30 compared to projected sham in the GALE extension study Estimated rate of retinal... Read More

Compact, single-use, on-body injector designed to enhance the patient experience of administering EMPAVELI ® (pegcetacoplan) WALTHAM, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI ® Injector. The... Read More

WALTHAM, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J2781) for SYFOVRE ® (pegcetacoplan injection), the first-ever treatment for geographic atrophy (GA) secondary to age-related macular degeneration. The J-code for SYFOVRE will become effective on... Read More

WALTHAM, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 5 new employees with a grant date of September 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive... Read More

WALTHAM, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will participate in the following investor conferences: Morgan Stanley 2023 Healthcare Conference: Fireside chat on Monday, September 11, 2023, at 10:00 a.m. ET Baird's 2023 Global Healthcare Conference: Presentation on Tuesday,... Read More

WALTHAM, Mass., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will participate in the following investor conferences: Citi Annual BioPharma Conference: Fireside chat on Wednesday, September 6, 2023, at 9:40 a.m. ET Wells Fargo Annual Healthcare Conference 2023: Fireside chat on Friday, September... Read More

Maximizing global leadership of SYFOVRE in geographic atrophy (GA) Streamlining the EMPAVELI business and prioritizing development of systemic pegcetacoplan in IC-MPGN/C3G Focusing research initiatives on retina and CNS Anticipated total cost savings of up to $300 million through 2024, which includes an approximately 25% reduction in current workforce and a reduction in external expenses WALTHAM, Mass., Aug. 29, 2023 (GLOBE... Read More

Internal structural variations were identified in the 19-gauge filter needle included in certain injection kits; Apellis recommends use of kits with the 18-gauge filter needle, which are already in distribution More than 100,000 vials have been distributed/administered between real world and clinical trials; since last update, confirmed one additional event of retinal vasculitis that occurred in May WALTHAM, Mass., Aug. 22,... Read More

WALTHAM, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 13 new employees with a grant date of August 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan)... Read More

Generated total U.S. net product revenues of $89.6 million, including $67.3 million for SYFOVRE ® (pegcetacoplan injection) and $22.3 million for EMPAVELI ® (pegcetacoplan) SYFOVRE reduced nonsubfoveal GA lesion growth by up to 45% between Months 24-30 compared to projected sham in the GALE long-term extension study Investigation on recently reported rare safety events with real-world use of SYFOVRE has found no indication... Read More

SYFOVRE reduced nonsubfoveal GA lesion growth by up to 45% between Months 24-30 compared to projected sham in the GALE long-term extension study Safety profile of SYFOVRE in GALE was consistent with previously reported clinical data Data presented during an oral presentation at the American Society of Retina Specialists (ASRS)... Read More

No indication that drug product or manufacturing issues contributed to rare events of retinal vasculitis Confirmed seven total events of non-occlusive/occlusive retinal vasculitis since launch; more than 68,000 SYFOVRE vials distributed to date Zero events were reported in clinical trials, following more than 23,000 clinical trial injections to date WALTHAM, Mass., July 29, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals,... Read More

WALTHAM, Mass., July 24, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will host a conference call and webcast to discuss its second quarter 2023 financial results on Monday, July 31, 2023, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the... Read More

New 30-month data from the GALE long-term extension study of SYFOVRE ® (pegcetacoplan injection) to be presented WALTHAM, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that seven abstracts will be presented as oral presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 28 to August 1 in Seattle. The upcoming data further... Read More

WALTHAM Mass., July 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 11 new employees with a grant date of July 3, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan)... Read More

WALTHAM, Mass., June 07, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Wednesday, June 14, 2023, at 9:20 a.m. PT. The event will be available via a live webcast from the “Events and Presentations” page of... Read More

WALTHAM, Mass., June 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to five new employees with a grant date of June 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive Plan)... Read More

WALTHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Phase 2 MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival (CAFS) rank score at Week 52. The study also did not meet key secondary efficacy endpoints. Systemic... Read More

WALTHAM, Mass., May 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 13 new employees with a grant date of May 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive Plan) and... Read More

Generated U.S. net product revenues of $18.4 million for SYFOVRE™ (pegcetacoplan injection) and $20.4 million for EMPAVELI ® (pegcetacoplan) SYFOVRE launched in the U.S. as the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) Validation received for marketing applications for intravitreal pegcetacoplan in the EU, Canada, Australia, the United Kingdom, and Switzerland;... Read More

WALTHAM, Mass., May 03, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will present at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023, at 3:40 p.m. PT. The event will be available via a live webcast from the “Events and Presentations” page of the “Investors and Media”... Read More

WALTHAM, Mass., April 27, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will host a conference call and webcast to discuss its first quarter 2023 financial results on Thursday, May 4, 2023, at 4:30 p.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the... Read More

Showed visual function and quality-of-life benefits in patients with extrafoveal lesions Slowed the loss of retinal pigmented epithelial and photoreceptor cells, both of which are required for visual function Eight abstracts, including three oral presentations, highlighted at ARVO annual meeting WALTHAM, Mass., April 23, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company... Read More

Applications are under review in Canada, Australia, the United Kingdom, and Switzerland Approval decisions expected in the first half of 2024 WALTHAM, Mass., April 21, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company has received validation of its marketing applications by regulatory authorities in Canada,... Read More

GA is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts approximately one million Americans Winkler and his family saw firsthand the impact of vision loss by caring for his father-in-law who was living with AMD Campaign encourages older adults to monitor and discuss vision changes with an eye doctor WALTHAM, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- Apellis... Read More

WALTHAM, Mass., April 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 7 new employees with a grant date of April 3, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive Plan)... Read More

WALTHAM Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 6 new employees with a grant date of March 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive Plan)... Read More

WALTHAM, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will participate in the following March investor conferences: Cowen 43rd Annual Healthcare Conference: Fireside chat on Wednesday, March 8, 2023, at 9:10 a.m. ET. Oppenheimer’s 33rd Annual Healthcare Conference: Virtual fireside chat... Read More

WALTHAM, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced the closing of its previously announced underwritten public offering of common stock and pre-funded warrants, including the exercise in full by the underwriters of their option to purchase an additional 833,333 shares. The exercise of the option to... Read More

WALTHAM, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, today announced the pricing of its underwritten public offering of 3,174,603 shares of its common stock at a public offering price of $63.00 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 2,380,956 shares of its common... Read More

WALTHAM, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. , (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, today announced that it has commenced an underwritten public offering of $300 million of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). All of the shares of common stock and pre-funded warrants are being offered by Apellis. In... Read More

SYFOVRE™ (pegcetacoplan injection) approved in the U.S. as the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) EU marketing authorization application for intravitreal pegcetacoplan validated by the European Medicines Agency; decision by European Commission (EC) expected in early 2024 EMPAVELI ® (pegcetacoplan) sNDA approved including Phase 3 PRINCE data and 48-week... Read More

SYFOVRE slowed GA progression with increasing effects over time Approved for all patients with GA, with dosing flexibility every 25 to 60 days Well-demonstrated safety profile following ~12,000 injections over 24 months Conference call today at 4:30 p.m. ET WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today... Read More

WALTHAM Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 8 new employees with a grant date of February 1, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive Plan)... Read More

WALTHAM, Mass., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company approved the grant of equity awards to 10 new employees with a grant date of January 3, 2023, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2022 Inducement Stock Incentive... Read More

WALTHAM, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that leading retina specialist Caroline Baumal, M.D., has joined Apellis as chief medical officer. Dr. Baumal replaces Federico Grossi, M.D., Ph.D., who plans to remain at Apellis until February 28, 2023 to help with the transition and preparations for... Read More

WALTHAM, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will present at the 41 st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 9:00 a.m. PT / 12:00 p.m. ET. The conference event will be available via a live webcast from the “Events and Presentations” page of the... Read More

WALTHAM, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related... Read More