Biotechnology

Cogent Biosciences Announces Positive Part 1b Data from SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis

02/29/2024

Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on: Excerpt from the Press Release: WALTHAM, Mass. and BOULDER, Colo., Feb. 22, 2024 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today…

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Ocugen, Inc. Announces Dosing Completion of Subjects with Stargardt in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410ST

02/28/2024

Excerpt from the Press Release: MALVERN, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for…

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Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

02/20/2024

— Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy — — Plans to open three additional sites in Eastern Europe in the coming months — — Preliminary interim data expected in 2H 2024 — Excerpt from the Press Release: SOUTH SAN…

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Aviceda Therapeutics Announces First Patient Dosed in Part 2 of the Phase 2/3 SIGLEC Clinical Trial Assessing AVD-104 for the Treatment of Geographic Atrophy

02/08/2024

Part 2 of the Phase 2/3 SIGLEC clinical trial is designed and powered to serve as the first pivotal trial to support approval of AVD-104 in geographic atrophy. Part 2 of SIGLEC is expected to enroll approximately 300 patients who will be randomly assigned to two arms of AVD-104 or active comparator (avacincaptad pegol) and…

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Intellia Therapeutics Announces Publication of Positive Interim Phase 1 Data for NTLA-2002 in Patients with Hereditary Angioedema in the New England Journal of Medicine

02/07/2024

Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that interim results from the Phase 1 portion of the Phase 1/2 study of NTLA-2002 were published online in the New England Journal of…

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Vera Therapeutics Presents Positive 72-Week Data Showing eGFR Stabilization in the Phase 2b ORIGIN Clinical Trial OLE in IgA Nephropathy

02/06/2024

– Participants treated with atacicept for 72 weeks showed consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, with stable eGFR over the duration of treatment – Placebo cohort participants who crossed over to atacicept 150 mg in the OLE had similar outcomes at 72 weeks as atacicept cohort in the first 36 weeks of…

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Flare Therapeutics Presents FX-909 Phase 1 Dose Escalation and Expansion Clinical Trial Design at the 2024 ASCO Genitourinary Cancers Symposium

02/02/2024

–First-in-human trial evaluating safety, tolerability, and clinical activity of FX-909 in patients with advanced solid malignancies including advanced urothelial carcinoma– Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 26, 2024 /PRNewswire/ — Flare Therapeutics Inc., a biotechnology company targeting transcription factors (TF) to discover precision medicines for cancer and other diseases, today announced a poster…

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Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS

01/25/2024

Excerpt from the Press Release: NAARDEN, Netherlands & WALTHAM, Mass.–(BUSINESS WIRE)–Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, will present clinical data supporting a future Phase 3 study in amyotrophic lateral sclerosis (ALS) during the 14th…

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Allurion Announces Publication of Randomized, Double-Blind Study Demonstrating Significant Improvement in Obesity-Related Co-Morbidities

01/23/2024

Allurion Program led to resolution of type 2 diabetes, hypertension, and obstructive sleep apnea in just 4 months in over half of the patients treated Results improved with addition of oral GLP-1 agonist semaglutide Excerpt from the Press Release: NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the…

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Elicio Therapeutics Announces First Patient Dosed in Randomized Phase 2 Pancreatic Cancer Study

01/18/2024

The 7-peptide formulation of ELI-002 is designed to stimulate an immune response against seven KRAS mutations that drive 25% of all solid tumors, potentially defeating resistance mechanismsElicio will present a Trial in Progressposter on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 Excerpt from the Press…

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