Register Login

Apellis Pharmaceuticals Inc (APLS)

(30% Negative) Apellis Pharmaceuticals Inc (APLS) Announces Delay in initiated Trials for EMPAVELI in two additional nephrology indications Due to Regulatory Process, Safety Review

Full text
Register to leave comments
  • News bot Jan. 29, 2026, 6:36 p.m.

    📋 Apellis Pharmaceuticals Inc (APLS) - Clinical Trial Update

    Filing Date: 2026-01-12

    Accepted: 2026-01-12 16:52:49

    Event Type: Clinical Trial Update

    Event Details:

    Apellis Pharmaceuticals Inc (APLS) Announces Clinical Trial Update Apellis Pharmaceuticals Inc (APLS) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: initiated, priorities
    • Diseases/Conditions: EMPAVELI in two additional nephrology indications
    • Clinical Stage: Pivotal trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Regulatory Process
    • Collaboration: FSGS
    • Updated Timeline: the full year 2025
      • targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on LinkedIn and X. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995
      • targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration. About EMPAVELI®/Aspaveli® (pegcetacoplan) EMPAVELI®/Aspaveli® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age or older, to reduce proteinuria. EMPAVELI/Aspaveli® is also approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. EMPAVELI is being evaluated for the treatment of additional rare diseases. About the Apellis and Sobi Collaboration Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection) CONTRAINDICATIONS • SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred. WARNINGS AND PRECAUTIONS • Endophthalmitis and Retinal Detachments • Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. • Retinal Vasculitis and/or Retinal Vascular Occlusion • Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. • Neovascular AMD • In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. • Intraocular Inflammation • In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. • Increased Intraocular Pressure • Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS • Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see full Prescribing Information for more information. for more information. U.S. Important Safety Information for EMPAVELI® (pegcetacoplan) BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. • Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. • Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS • Hypersensitivity to pegcetacoplan or to any of the excipients • For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at www.empavelirems.com or 1-888-343-7073
      • expected in 2027

    🔬 Clinical Development Pipeline (Apellis Pharmaceuticals Inc):

    Product Type Development Stage Therapeutic Area Source
    Drug: Furmonertinib 80 mg DRUG Phase PHASE3 Non-small Cell Lung Carcinoma ClinicalTrials.gov
    APL-3007, pegcetacoplan (APL-2) DRUG Phase PHASE2 Geographic Atrophy Secondary to Age-related Macular Degeneration ClinicalTrials.gov
    Patient-initiated treatment OTHER Approved Blepharospasm ClinicalTrials.gov
    LB-102 DRUG Phase PHASE3 Schizophrenia ClinicalTrials.gov
    Placebo OTHER Phase PHASE3 Schizophrenia ClinicalTrials.gov
    LB-102 (100 mg tablet) DRUG Phase PHASE3 Schizophrenia ClinicalTrials.gov
    LB-102 (50 mg tablet) DRUG Phase PHASE3 Schizophrenia ClinicalTrials.gov
    Placebo, Syfovre OTHER Phase PHASE2 Geographic Atrophy Secondary to Age-related Macular Degeneration ClinicalTrials.gov
    APL-2, Pegcetacoplan DRUG Phase PHASE3 Geographic Atrophy Secondary to Age-related Macular Degeneration ClinicalTrials.gov
    Furmonertinib DRUG Phase PHASE2 NSCLC ClinicalTrials.gov
    Furmonertinib 240mg DRUG Phase PHASE1 NSCLC ClinicalTrials.gov
    Furmonertinib 160mg DRUG Phase PHASE1 NSCLC ClinicalTrials.gov
    Pegcetacoplan DRUG Preclinical C3G ClinicalTrials.gov
    PEGCETACOPLAN (APL-2) DRUG Phase PHASE3 Geographic Atrophy Secondary to Age-related Macular Degeneration ClinicalTrials.gov
    APL2 DRUG Phase PHASE2 FSGS ClinicalTrials.gov
    Oxymorphone ER DRUG Phase PHASE3 Pain ClinicalTrials.gov
    Lidoderm DRUG Phase PHASE4 Diabetes ClinicalTrials.gov
    Lidoderm® DRUG Phase PHASE4 Chronic Low Back Pain ClinicalTrials.gov
    0.15% azelastine hydrochloride Nasal Spray DRUG Phase PHASE3 Seasonal Allergic Rhinitis ClinicalTrials.gov
    Placebo nasal spray DRUG Phase PHASE3 Seasonal Allergic Rhinitis ClinicalTrials.gov
    Oxymorphone extended release DRUG Phase PHASE3 Pain ClinicalTrials.gov
    VSL#3 DRUG Phase PHASE1 Fatty Liver ClinicalTrials.gov
    0.15% azelastine hydrochloride DRUG Phase PHASE3 Seasonal Allergic Rhinitis ClinicalTrials.gov
    Usual Care DRUG Phase PHASE4 Menstrual Migraine (MM) Headaches ClinicalTrials.gov
    Frovatriptan DRUG Phase PHASE4 Menstrual Migraine (MM) Headaches ClinicalTrials.gov
    0.1% azelastine hydrochloride 1096 mcg daily DRUG Phase PHASE3 Seasonal Allergic Rhinitis ClinicalTrials.gov
    0.15% azelastine hydrochloride 1644 mcg daily DRUG Phase PHASE3 Seasonal Allergic Rhinitis ClinicalTrials.gov
    Placebo patch DRUG Phase PHASE2 Osteoarthritis, Knee ClinicalTrials.gov
    collagenase clostridium histolyticum BIOLOGICAL Phase PHASE3 Dupuytren's Disease ClinicalTrials.gov
    Astelin Nasal Spray (0.1% azelastine hydrochloride) DRUG Phase PHASE3 Chronic Allergic Rhinitis ClinicalTrials.gov
    Astepro Nasal Spray (0.1% azelastine hydrochloride) DRUG Phase PHASE3 Chronic Allergic Rhinitis ClinicalTrials.gov
    Celecoxib DRUG Phase PHASE4 Osteoarthritis of the Knee ClinicalTrials.gov
    Ketoprofen Topical Patch 20% DRUG Phase PHASE3 Tendonitis ClinicalTrials.gov
    Oxymorphone IR DRUG Phase PHASE3 Post-operative Pain ClinicalTrials.gov
    AST2818 Tablets DRUG Phase PHASE1 Healthy Male Volunteers ClinicalTrials.gov
    [14]-AST2818 DRUG Phase PHASE1 Healthy Male Volunteers ClinicalTrials.gov
    Sham Procedure OTHER Phase PHASE2 Geographic Atrophy ClinicalTrials.gov
    Zilucoplan (RA101495) DRUG Phase PHASE2 Paroxysmal Nocturnal Hemoglobinuria (PNH) ClinicalTrials.gov
    EN3835 DRUG Phase PHASE3 Edematous Fibrosclerotic Panniculopathy (EFP) ClinicalTrials.gov
    Collagenase Clostridium Histolyticum Multiple Injection Technique DRUG Phase PHASE2 Characteristics of Subcutaneous Tissue ClinicalTrials.gov
    Collagenase Clostridium Histolyticum Single Injection Technique DRUG Phase PHASE2 Characteristics of Subcutaneous Tissue ClinicalTrials.gov
    Furmonertinib (160mg) DRUG Phase PHASE2 Non-Small-Cell Lung Cancer ClinicalTrials.gov
    Soliris DRUG Phase PHASE3 Paroxysmal Nocturnal Hemoglobinuria ClinicalTrials.gov
    Oxymorphone HCl DRUG Phase PHASE3 Post-Operative Pain ClinicalTrials.gov
    Vehicle Control OTHER Phase PHASE1 COVID ClinicalTrials.gov
    APL-9 DRUG Phase PHASE1 COVID ClinicalTrials.gov
    zilucoplan DRUG Phase PHASE2 Immune Mediated Necrotizing Myopathy ClinicalTrials.gov
    Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    Furmonertinib/Pemetrexed/Carboplatin DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    EOM613 DRUG Phase PHASE1 COVID-19 Pneumonia ClinicalTrials.gov
    APL-2 DRUG Phase PHASE3 Geographic Atrophy ClinicalTrials.gov
    Anlotinib DRUG Phase PHASE2 Non-Small-Cell Lung Cancer ClinicalTrials.gov
    JAB 21822 DRUG Phase PHASE1 Non-small Cell Lung Cancer ClinicalTrials.gov
    Alflutinib DRUG Phase PHASE2 Advanced NSCLC Patients With T790M ClinicalTrials.gov
    [14C]JAB-21822 DRUG Phase PHASE1 Mass Balance Study in Healthy Subjects ClinicalTrials.gov
    JAB-21822 DRUG Phase PHASE1 NSCLC ClinicalTrials.gov
    AST2303 Tablets(ABK3376 Tablets) ，125mg DRUG Phase PHASE1 Locally Advanced or Metastatic Non-small Cell Lung Cancer ClinicalTrials.gov
    AST2303 Tablets(ABK3376 Tablets) ，100mg DRUG Phase PHASE1 Locally Advanced or Metastatic Non-small Cell Lung Cancer ClinicalTrials.gov
    AST2303 Tablets(ABK3376 Tablets) ，75mg DRUG Phase PHASE1 Locally Advanced or Metastatic Non-small Cell Lung Cancer ClinicalTrials.gov
    AST2303 Tablets(ABK3376 Tablets) ，50mg DRUG Phase PHASE1 Locally Advanced or Metastatic Non-small Cell Lung Cancer ClinicalTrials.gov
    AST2303 Tablets(ABK3376 Tablets) ，25mg DRUG Phase PHASE1 Locally Advanced or Metastatic Non-small Cell Lung Cancer ClinicalTrials.gov
    Carboplatin DRUG Phase PHASE3 Advanced Non-squamous Non-small-cell Lung Cancer ClinicalTrials.gov
    Pemetrexed DRUG Phase PHASE3 Advanced Non-squamous Non-small-cell Lung Cancer ClinicalTrials.gov
    JAB-3312 DRUG Phase PHASE3 Advanced Non-squamous Non-small-cell Lung Cancer ClinicalTrials.gov
    Tislelizumab DRUG Phase PHASE3 Advanced Non-squamous Non-small-cell Lung Cancer ClinicalTrials.gov
    Furmonertinib 80 mg placebo DRUG Phase PHASE3 Non-small Cell Lung Carcinoma ClinicalTrials.gov
    Carboplatin Injection DRUG Phase PHASE3 EGFR ClinicalTrials.gov
    Cisplatin for injection DRUG Phase PHASE3 EGFR ClinicalTrials.gov
    Pemetrexed Disodium for Injection DRUG Phase PHASE3 EGFR ClinicalTrials.gov
    Firmonertinib Mesilate Tablets DRUG Phase PHASE3 EGFR ClinicalTrials.gov
    Placebo AST2818 80mg//40 mg DRUG Phase PHASE3 Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer ClinicalTrials.gov
    Gefitinib 250 mg DRUG Phase PHASE3 Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer ClinicalTrials.gov
    Placebo Gefitinib 250 mg DRUG Phase PHASE3 Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer ClinicalTrials.gov
    Alflutinib Mesylate (AST2818) 80mg//40 mg+ placebo DRUG Phase PHASE3 Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer ClinicalTrials.gov
    Rifampicin DRUG Phase PHASE1 Healthy Subjects ClinicalTrials.gov
    Midazolam , Rosuvastatin calcium and digoxin DRUG Phase PHASE1 Healthy Subjects ClinicalTrials.gov
    Omeprazole DRUG Phase PHASE1 Healthy Subjects ClinicalTrials.gov
    Itraconazole DRUG Phase PHASE1 Healthy Subjects ClinicalTrials.gov
    Cetuximab DRUG Phase PHASE1 Advanced Colorectal Cancer ClinicalTrials.gov
    Osimertinib Mesylate Tablets DRUG Phase PHASE3 NSCLC Patients With Brain Metastasis ClinicalTrials.gov
    Furmonertinib Mesilate Tablets DRUG Phase PHASE3 NSCLC Patients With Brain Metastasis ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Apellis Pharmaceuticals Inc
    • Ticker Symbol: APLS

Search

News categories