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Day: October 26, 2024

Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial 

New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1 Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of kidney function – vs. patients’ historic rapid decline1 Fabhalta also showed a favorable safety profile with no new safety signals1 Fabhalta is the only oral alternative complement pathway inhibitor to selectively target the underlying cause of C3G, an ultra-rare kidney disease with no approved treatments2-5 Novartis continues to advance multi-asset renal portfolio; C3G regulatory submissions completed in EU, China and Japan, and expected in US by year-end Basel, October 27, 2024 – Novartis today presented 12-month data from the Phase III APPEAR-C3G study at American Society of Nephrology (ASN) Kidney Week 2024 showing that patients with...

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Vera Therapeutics Announces 96-week eGFR Stabilization in ORIGIN Phase 2b Study of Atacicept in IgAN in a Late-Breaking Oral Presentation at the American Society of Nephrology Kidney Week 2024

Long-term improvements observed in the quartet of findings defining disease modification supports atacicept’s potential to prevent kidney failure in patients with IgAN; Long-term results from the ORIGIN Phase 2b study were simultaneously published in the Journal of the American Society of Nephrology; Company will host an investor call and webcast on Monday October 28 at 8:00 AM ET BRISBANE, Calif., Oct. 26, 2024 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN) that show stabilized kidney function through 96 weeks of long-term follow-up. These data were presented...

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Celldex Announces Barzolvolimab Met All Primary and Secondary Endpoints with High Statistical Significance in Positive Phase 2 Study in Chronic Inducible Urticaria

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 development Company to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity,...

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Travere Therapeutics Presents Data Reinforcing Clinical Benefit of FILSPARI® (Sparsentan) in IgAN and Late-Breaking Presentation in FSGS at ASN Kidney Week 2024

Nearly 60% of patients with IgAN in the SPARTAN Study achieved complete remission when using FILSPARI as first-line treatment SPARTACUS Study, PROTECT open-label extension, and real-world evidence presentations highlight initial safety and efficacy data of FILSPARI in combination treatment in IgAN Late-breaking presentation demonstrates sparsentan delivered rapid and sustained proteinuria reduction, and long-term kidney health benefits in a subset of patients with genetic, often treatment resistant, FSGS SAN DIEGO, Oct. 26, 2024 (GLOBE NEWSWIRE) — Travere Therapeutics, Inc., (Nasdaq: TVTX), presented new data further demonstrating the clinical benefit of FILSPARI (sparsentan) in IgA nephropathy (IgAN) and reinforcing its potential in focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology (ASN) Kidney...

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Vivoryon Therapeutics N.V. Presents Outstanding Phase 2b Results of Varoglutamstat on Kidney Function at ASN Kidney Week 2024

Vivoryon Therapeutics N.V. Presents Outstanding Phase 2b Results of Varoglutamstat on Kidney Function at ASN Kidney Week 2024 Selected for late-breaking oral presentation at ASN kidney week, the world’s premier nephrology meeting Results presented show a statistically significant and clinically meaningful improvement of the prospectively defined kidney function parameter eGFR1 by 3.4mL/min/year (p68 years, dosing was twice-daily with either 300mg or 600mg varoglutamstat, or placebo and treatment duration was 48-96 weeks; key kidney-related study features included a mean baseline eGFR of ~80mL/min/1.73m2, eGFR, urine dipstick and vital signs measured every 12 weeks; the diabetes subgroup comprised ~12% of VIVIAD patients. Compelling efficacy and safety data in elderly people at risk for kidney disease: eGFR improved significantly for...

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Cielo Provides Virtual AGM Reminder and Announces Extension of Proxy Voting Deadline

CALGARY, Alberta, Oct. 26, 2024 (GLOBE NEWSWIRE) — Cielo Waste Solutions Corp. (TSXV:CMC; OTC PINK:CWSFF) (“Cielo” or the “Company”), a company fueling renewable change, wishes to remind its shareholders that its forthcoming Annual General Meeting of shareholders (the “AGM”) will be held on Tuesday, October 29, 2024, at 10 a.m. MT. As the AGM will be held virtually, shareholders will not be able to attend in person. To attend the AGM, shareholders will have to access the following link online: https://teams.microsoft.com/CieloAGM2024 (meeting ID 218 185 286 033, passcode 5A4kx6). Shareholders will have an equal opportunity to participate at the AGM by video conference regardless of their geographic location. Additional details related to the AGM, including the method of attending the AGM virtually, are described in the Company’s...

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El Pollo Loco Turns Up The Heat with Exclusive Mango Habanero Flavor Test

The perfectly sweet and irresistibly spicy chicken meals will be available at select locations for a limited time COSTA MESA, Calif., Oct. 25, 2024 (GLOBE NEWSWIRE) — El Pollo Loco, the nation’s leading fire-grilled chicken restaurant, is turning up the heat with a limited-time test of its all-new Mango Habanero sauce— available exclusively in select Orange County and Los Angeles locations. WHO:El Pollo Loco, beloved for its craveable, better-for-you fire-grilled chicken and bold flavors, is testing a thrilling new menu item that fans won’t want to miss. WHAT:The chefs at El Pollo Loco have outdone themselves with this sweet and spicy creation! The restaurant chain’s famous fire-grilled chicken is coated with the new signature Mango Habanero sauce, which is perfectly sweet and irresistibly spicy. Available as your favorite...

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