Industry News

Tenaya Therapeutics Doses First Patient in RIDGE™-1 Phase 1b Clinical Trial of TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy

12/06/2024

TN-401 AAV9-based Gene Therapy Designed to Deliver Fully Functional PKP2 Gene with the Aim of Increasing Protein Levels to Address Underlying Disease RIDGE-1 Currently Enrolling at Six Centers; Observational Natural History and Seroprevalence Study of PKP2-associated ARVC Adults Continues Enrollment at 20 Clinical Sites in the U.S., UK and Europe Initial Clinical Data for RIDGE-1…

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Scribe Therapeutics Reports Preclinical Data Validating its CRISPR Genome Editing and Epigenome Modifying Technologies for Addressing Cardiometabolic Disease at American Heart Association (AHA) Scientific Sessions 2024

12/05/2024

Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Scribe Therapeutics Inc. (Scribe), a genetic medicines company unlocking the potential of CRISPR to transform human health, presented preclinical data on its CRISPR X-Editor (XE) and Epigenetic Long-Term X-Repressor (ELXR) technologies at the American Heart Association’s Scientific Sessions 2024. The new data described in Scribe’s late-breaking, oral, and…

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Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of Hallucination-like Behavior

12/04/2024

Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog pharmacokinetic (PK) studies while significant brain penetration was observed in rat Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogen…

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New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®

12/03/2024

The Study Results are Published in the Journal of Urology Online Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is…

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HUYABIO Presents Positive Phase 2 Data on HBI-8000 and Nivolumab Combination for Advanced Melanoma

11/18/2024

Data supporting the potential for innovative combinations like HBI-8000 and nivolumab to reshape the future of melanoma treatment will be presented at the Society for Immunotherapy of Cancer Annual Meeting Excerpt from the Press Release: SAN DIEGO, Nov. 8, 2024 /PRNewswire/ — HUYABIO International today announced it will present the final analysis of data from a phase…

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Nektar and Collaborators Present Late-breaking Results from Phase 2 Study of NKTR-255 for the Treatment of Radiation Induced Lymphopenia in Locally Advanced Non-Small Cell Lung Cancer Patients at Society for Immunotherapy of Cancer (SITC) Annual Meeting

11/14/2024

NKTR-255 administered post completion of concurrent chemoradiation and in combination with durvalumab demonstrated statistically significant lymphocyte recovery compared to historical controls at week 8 – – Pharmacodynamic data show NKTR-255 increased NK cell proliferation and markers of NK cell activation  – Excerpt from the Press Release: SAN FRANCISCO, Nov. 7, 2024 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR)…

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Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference

11/11/2024

Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible Excerpt from the Press Release: NEWTON, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company…

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ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

11/08/2024

Efficacy signals observed will not achieve ESSA’s target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination…

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HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases

11/07/2024

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604. HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.…

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Skye Bioscience Demonstrates Prominent Role of Peripheral CB1 Inhibition and Achieves Significant Weight Loss with Novel CB1-inhibiting Antibody, Nimacimab, in Preclinical Model

11/06/2024

Peripherally-restricted nimacimab achieves significant dose-dependent weight loss, fat mass reduction, lean mass preservation, and glycemic control in diet-induced obesity model Preliminary data shows that nimacimab achieves desired metabolic outcomes without central inhibition and its risk of neuropsychiatric adverse events Excerpt from the Press Release: SAN DIEGO, Nov. 04, 2024 (GLOBE NEWSWIRE) — Skye Bioscience, Inc.…

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