Month: August 2025

N-Power Medicine Launches Industry’s First Prospective External Control Arm Platform to Dramatically Accelerate Oncology Drug Development and Reduce Reliance on Randomization

08/29/2025

Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–N-Power Medicine, a company reimagining oncology drug development, today announced the launch of the industry’s first Prospective External Control Arm (ProECA) platform for pharmaceutical and biotechnology partners. Designed to reduce reliance on traditional randomized clinical trials, this groundbreaking model aims to cut patient enrollment requirements by up…

Read More

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

08/28/2025

– A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first…

Read More

First PRIZM Study Participant Enrolled in Tisento Therapeutics’ Open-Label Extension Study in MELAS

08/27/2025

Participants Who Complete Treatment in Global Phase 2b PRIZM MELAS Study Are Eligible to Enroll Excerpt from the Press Release: CAMBRIDGE, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) — Tisento Therapeutics today announced that the first participant has enrolled in the company’s open-label extension study in MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). The extension…

Read More

Rocket Pharmaceuticals Announces FDA Has Lifted the Clinical Hold on the Pivotal Phase 2 Trial of RP-A501 for the Treatment of Danon Disease

08/26/2025

Excerpt from the Press Release: CRANBURY, N.J.–(BUSINESS WIRE)–Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of…

Read More

Children’s Hospital of Philadelphia Researchers Find that Missing Messenger RNA Fragments Could be Key to New Immunotherapy for Hard-to-Treat Tumors

08/25/2025

The researchers identified a potential therapeutic vulnerability in pediatric high-grade gliomas Excerpt from the Press Release: PHILADELPHIA, Aug. 15, 2025 /PRNewswire/ — A new study, led by researchers at Children’s Hospital of Philadelphia (CHOP), identified tiny pieces of messenger RNA that are missing in pediatric high-grade glioma tumors but not in normal brain tissues. Preclinical…

Read More

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

08/22/2025

Excerpt from the Press Release: MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and…

Read More

Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme

08/21/2025

First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) Excerpt from the Press Release: BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune…

Read More

Data Published in The Laryngoscope shows INO-3107 Resulted in Long-Term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP)

08/20/2025

Excerpt from the Press Release: PLYMOUTH MEETING, Pa., Aug. 11, 2025 /PRNewswire/ — INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that peer-reviewed data from a retrospective study investigating the long-term clinical and safety response…

Read More

Aligos Therapeutics Announces First Subject Dosed in the Phase 2 B-SUPREME Study of ALG-000184 in Subjects with Chronic HBV Infection

08/19/2025

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has…

Read More

Nalu Announces Publication of Results from COMFORT 2 Randomized Control Trial (RCT) Making Nalu the First Permanent PNS Device to Demonstrate Level-1 Clinical Evidence

08/18/2025

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–The results of COMFORT 2, the second Nalu Medical Peripheral Nerve Stimulation (PNS) RCT, were published on July 30th, 2025, in the peer-reviewed journal Chronic Pain & Management and are available here. These results confirm the positive clinical outcomes from the COMFORT trial, the first Nalu PNS RCT,…

Read More