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

By Global News Feed

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, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

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

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

By Global News Feed

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 C3 glomerulopathy (C3G) treated with oral Fabhalta® (iptacopan) in addition to supportive care experienced clinically meaningful, sustained results at one year.1

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

Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024

By Global News Feed

CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – today presented complete results from the Phase 2 IGNAZ study evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in people living with IgA nephropathy (IgAN). The results showed substantial reductions in proteinuria, stabilization of kidney function, and sustained treatment effect more than 18 months after the last dose of felzartamab. The complete results were shared during an oral presentation at Kidney Week 2024, the American Society of Nephrology’s annual meeting, in San Diego, California.

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Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024

Phathom Pharmaceuticals to Present VOQUEZNA® Data at the American College of Gastroenterology (ACG) 2024 Annual Meeting

By Global News Feed

FLORHAM PARK, N.J., Oct. 27, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the company will present data from multiple investigational studies for its first-in-class treatment VOQUEZNA® (vonoprazan) tablets at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, being held October 25-30 in Philadelphia, PA. VOQUEZNA is approved for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD), for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn, and in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) infection.1 VOQUEZNA is the first and only U.S. Food and Drug Administration (FDA)-approved potassium-competitive acid blocker (PCAB).2

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Phathom Pharmaceuticals to Present VOQUEZNA® Data at the American College of Gastroenterology (ACG) 2024 Annual Meeting

Longeveron® Presents Lomecel-B™ Long-term Transplant-free Survival Data in Hypoplastic Left Heart Syndrome (HLHS) at the Congenital Heart…

By Global News Feed

MIAMI, Oct. 27, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that its positive long-term transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial were featured in an oral presentation at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting taking place October 27-28, 2024 in Chicago, Illinois.

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Longeveron® Presents Lomecel-B™ Long-term Transplant-free Survival Data in Hypoplastic Left Heart Syndrome (HLHS) at the Congenital Heart...

Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

By Global News Feed

Basel, October 18, 2024 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease1.

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Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

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