Industry News

Revolution Medicines Doses First Patient in Phase 1/1b Clinical Trial of RMC-6291, Company’s First Mutant-Selective RAS(ON) Inhibitor

09/30/2022

KRASG12C(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring KRASG12C mutation RMC-6291 is first mutant-selective RAS(ON) Inhibitor to enter clinic, following closely behind company’s RASMULTI(ON) Inhibitor, RMC-6236 Excerpt from the Press Release: REDWOOD CITY, Calif., Sept. 22, 2022 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology…

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Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes

09/30/2022

Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

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Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

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Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal Epilepsy

09/28/2022

Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant Data Safety Monitoring Board clears advancement of trial to continue enrollment Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic…

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ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval

09/28/2022

Excerpt from the Press Release: FREEMONT, CA, Sept. 23, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced enrollment progress in the Phase II Part 2 clinical study of the Company’s ADHD medicine, ABV-1505, currently being conducted at…

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Sight Sciences Announces Completion of Enrollment in SAHARA, a Randomized Clinical Trial of the TearCare® System vs Restasis®

09/27/2022

310-patient RCT designed to evaluate the superiority of TearCare® (device) vs Restasis® (drug) in patients with chronic dry eye disease is now fully enrolled 6-Month efficacy results expected by Summer 2023 Excerpt from the Press Release: MENLO PARK, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused…

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Sagimet Biosciences Announces Completion of Patient Enrollment in Phase 2b ‘FASCINATE-2’ Clinical Trial with Denifanstat (TVB-2640), a First-in-Class Fatty Acid Synthase Inhibitor, in Non-alcoholic Steatohepatitis

09/27/2022

Excerpt from the Press Release: SAN MATEO, Calif.–(BUSINESS WIRE)–Sagimet Biosciences, a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, announced today that it has completed enrollment of its Phase 2b liver biopsy-based clinical trial (“FASCINATE-2”) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis (NASH) patients. “Completing patient enrollment in the…

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Nura Bio Reports Preclinical Data Validating a Conserved Mechanism of Inhibition of NAD Hydrolases Implicated in Neurodegeneration in Neuron

09/26/2022

– Potent, uncompetitive inhibitors of the pro-degenerative NADase SARM1 reported – Molecular basis of product-assisted inhibition of NAD hydrolases like SARM1 and CD38 that have been implicated in neurological diseases elucidated – Research supports Nura Bio’s goal of entering First-in-Human trials with oral, brain-penetrant SARM1 inhibitors in early 2023 Excerpt from the Press Release: SOUTH…

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In Akero Therapeutics’ Phase 2b HARMONY Study, Both the 50mg and 28mg EFX Doses Achieved Statistical Significance on Primary and Secondary Histology Endpoints after 24 Weeks

09/26/2022

50mg (41%) and 28mg (39%) groups demonstrated ≥1 stage improvement in fibrosis without worsening of NASH, double the placebo rate (20%) 50mg (76%) and 28mg (47%) groups demonstrated NASH resolution without worsening of fibrosis, three to five times the placebo rate (15%) 50mg (41%) and 28mg (29%) groups demonstrated fibrosis improvement AND resolution of NASH,…

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Join Christopher Kata in San Diego for the “IN”novation Mixer Networking Event on September 28th!

09/25/2022

We’re extending this special invitation to our “IN”novation Mixer event, hosted by TrialStat Solutions, Avance Clinical, Science Media and Life Sciences Marketplace on Wednesday, September 28th, starting at 5 pm PT at The Winery Restaurant and Wine Bar, located in the UTC Westfield Plaza at 4301 La Jolla Village Dr Ste 2040, San Diego, CA 92122. Please join Christopher Kata, and a select…

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