Month: September 2025

Orchestra BioMed Presents New AVIM Therapy Clinical Data at HRX Demonstrating Substantial and Sustained Blood Pressure Reductions that are Reproducible Upon Reactivation Following Washout

09/12/2025

Excerpt from the Press Release: NEW HOPE, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced new data from its AVIM therapy program, presented at the HRX Live 2025 Meeting, in Atlanta,…

Why Consistent Platform Iteration Is a Game-Changer for Clinical Trials

09/11/2025

How TrialStat’s Quarterly Releases Deliver Real Value to Sponsors, CROs, and Sites In today’s fast-paced clinical research environment, flexibility and responsiveness aren’t just nice-to-haves-they’re mission-critical. At TrialStat, our commitment to quarterly platform releases is rooted in one goal: to empower our clients with a nimble, innovative, and responsive technology ecosystem that grows with their needs.…

Ibex Medical Analytics Announces IVDR Certification for HER2 Biomarker Scoring Solution in Breast Cancer

09/11/2025

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution. Ibex’s fully automated “zero-click” AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency…

Join The TrialStat Team in Amsterdam at the COG CRO Summit

09/10/2025

The TrialStat team is showcasing their cutting-edge EDC Platform with integrated Medical Imaging Workflow Platform at the COG CRO Summit in Amsterdam. This conference provides an exceptional opportunity for in-depth discussions on how our platform is advancing imaging based research and streamlining clinical trial execution for Sponsors and CROs. Meet with Chris Hamelin and Nick…

uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease

09/10/2025

~ All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level ~ ~ All patients in first cohort discontinued enzyme replacement therapy ~ ~ Preliminary data show AMT-191 has a manageable safety profile at the highest dose ~ ~ Updated clinical results expected in…

Ashvattha Therapeutics Announces Positive Topline 40-Week Phase 2 Results for Migaldendranib in Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

09/09/2025

Migaldendranib (MGB) is a new class of targeted nanomedicine for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) with a novel mechanism of action that normalizes VEGF expression. End of study, 40-week results demonstrated that MGB, delivered via subcutaneous (subQ) administration, is safe and well-tolerated with no MGB treatment-related ocular…

Veracyte Announces New Study Published in Cell Shows that Decipher Prostate Test Predicts Chemotherapy Benefit in Patients with Metastatic Prostate Cancer

09/08/2025

Findings are from the multicenter, prospective, Phase 3 STAMPEDE trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, and University College London (UCL) today announced that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are…

MediciNova Achieves Enrollment in COMBAT-ALS Clinical Trial

09/05/2025

Excerpt from the Press Release: LA JOLLA, Calif., Aug. 26, 2025 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it successfully achieved enrollment of the target number of participants in its COMBAT-ALS Phase…

Kyverna Therapeutics Highlights Neuroimmunology CAR T Franchise and Registrational Phase 3 Trial Design in Myasthenia Gravis at Virtual KOL Event

09/04/2025

KYV-101 has the potential to deliver durable, drug-free, disease-free remission in myasthenia gravis and set a new treatment standard for stiff person syndrome Innovative FDA-aligned KYSA-6 Phase 3 trial design for myasthenia gravis supportsclear and rapid path to BLA Excerpt from the Press Release: EMERYVILLE, Calif., Aug. 28, 2025 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc.…

Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy

09/03/2025

Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference Excerpt from the Press Release: CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995,…