Month: November 2024

Meet with Christopher Kata and the TrialStat team during the Clinical Outsourcing Group CRO Summit, December 3rd – 4th in Raleigh, NC!

11/12/2024

Meet with Christopher Kata, Director of Sales & Marketing December 3rd – 4th, 2024 at the Clinical Outsourcing Group CRO Summit Raleigh, NC! If you’re attending be sure to to reach out to Christopher to schedule a one on meeting or just drop by booth at your convenience! We’re looking forward to providing live, personalized…

Read More

Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

11/12/2024

Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 Excerpt from the Press Release:…

Read More

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…

Read More

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…

Read More

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.…

Read More

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.…

Read More

Maze Therapeutics Reports Positive First-in-Human Data from Phase 1 Healthy Volunteer Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease (AKD)

11/05/2024

MZE829 Well-tolerated with Dose-proportional Pharmacokinetics Supporting Once Daily Dosing Data Support Advancement of MZE829 into Planned Phase 2 Clinical Trial in Patients with AKD Data Presented Today at the American Society of Nephrology Kidney Week 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, CA., October 25, 2024 – Maze Therapeutics, a clinical-stage biopharmaceutical company…

Read More

Evoke Pharma & EVERSANA Announce Statistically Significant Improvement in Patient Outcomes for GLP-1 users with Diabetic Gastroparesis using GIMOTI®

11/04/2024

Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American…

Read More

Candel Therapeutics Showcases Innovative Cancer Therapy Candidates at 16th Annual International Oncolytic Virotherapy Conference (IOVC)

11/01/2024

Excerpt from the Press Release: NEEDHAM, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced three presentations at the 16th Annual International Oncolytic Virotherapy Conference (IOVC), taking place October 27-30, 2024,…

Read More