Biotechnology

Prime Medicine Announces U.S. FDA Clearance of Investigational New Drug Application for PM577a in H1069Q-mutated Wilson Disease

08/03/2026

— FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a — — PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe — — Initial clinical data expected in 2027 — Excerpt from the Press…

Allogene Therapeutics Announces Journal of Clinical Oncology Publication of Phase 1 Results of ALLO-316 Highlighting First Durable Remissions Following Allogeneic CAR T for Treatment of Metastatic Solid Tumors

07/28/2026

ALLO-316 Achieved a 31% Confirmed Response Rate with the Recommended Phase 2 Regimen in Patients with Stage IV Renal Cell Carcinoma (RCC) with High CD70 Expression Safety Profile was Manageable with Proactive Diagnostic and Management Strategies Effective in Mitigating IEC-HSALLO-316 Demonstrated Robust Expansion and Tumor Infiltration Following Standard Lymphodepletion, Validating the Dagger® Technology as a…

Mwyngil Therapeutics Announces Positive in vivo Proof of Concept Data for First-in-Class GPR75 Inverse Agonist in Obesity and Cardiometabolic Disease.

07/02/2026

Lead oral compounds demonstrated up to 25% body weight reduction with preferential fat loss, preserved lean mass, and broad metabolic improvements in DIO models Excerpt from the Press Release: BOSTON, June 25, 2026 /PRNewswire/ — Mwyngil Therapeutics, a biotech company focused on developing innovative small molecule therapeutics for cardiometabolic disease, today announced positive in vivo…

NeuroSense Reports Positive Biomarker Findings from Phase 2 RoAD Proof-of-Concept Study of PrimeC in Alzheimer’s Disease

06/30/2026

PrimeC was associated with changes across multiple biomarkers spanning key neurodegenerative disease pathways, providing early biological evidence consistent with potential target engagement Findings support continued development of PrimeC’s multi-target approach in Alzheimer’s disease Excerpt from the Press Release: CAMBRIDGE, Mass., June 25, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology…

Voro Therapeutics and Alloy Therapeutics Enter Strategic Research Collaboration to Advance Next-Generation Masked T-Cell Engager Therapeutics

06/29/2026

Collaboration combines Voro’s tumor-activated biologics platform and T-cell engager (TCE) expertise with Alloy’s antibody discovery and TCE engineering capabilities to develop novel tumor-selective immunotherapies Excerpt from the Press Release: SAN DIEGO & BOSTON–(BUSINESS WIRE)–Voro Therapeutics, a biotechnology company developing tumor-activated biologics designed to improve the therapeutic index of immune therapies, and Alloy Therapeutics, a biotechnology…

Insilico Completes First-in-Human Dosing in Phase I Clinical Study of AI-Driven NLRP3 Inhibitor ISM8969, Achieving First Clinical Milestone in Collaboration with Hygtia Therapeutics

06/24/2026

Excerpt from the Press Release: CAMBRIDGE, Mass. and HONG KONG, June 17, 2026 /PRNewswire/ — Insilico Medicine (“Insilico”, HKEX: 3696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI), today announced it has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics with the completion of first-in-human dosing in the Phase…

Autobahn Therapeutics Presents New Preclinical Data at ASCP Annual Meeting Demonstrating Elunetirom Drives Robust Bioenergetic and Neuroplastic Improvements in Neuronal Cultures

05/29/2026

New preclinical findings demonstrate elunetirom’s direct effects on key gene programs that drive mitochondrial biogenesis, ATP production, and neuroplasticity in neuronal cultures Topline data anticipated from Phase 2 AMPLIFY-BD study in adjunctive bipolar depression in 2Q26 and Phase 2 AMPLIFY study in adjunctive major depressive disorder in 3Q26 Excerpt from the Press Release: SAN DIEGO–(BUSINESS…

Arsenal Medical Receives FDA IDE Approval for the RADIANT Pivotal Trial of NeoCast™ in Chronic Subdural Hematoma

05/28/2026

A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Arsenal Medical, a clinical-stage company developing innovative biomaterial-based devices, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a…

Scribe Therapeutics Achieves Regulatory Clearance to Initiate First-in-Human Clinical Study of STX-1150 for LDL-C Reduction

05/26/2026

Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to extend healthy lifespan through disease prevention and durable therapeutic intervention, today announced that it has secured clearance from the Australian Therapeutic Goods Administration (TGA) to initiate a first-in-human clinical study of STX-1150…

Elion Therapeutics Announces Initiation of Turletricin (EL219) Phase 2 Study in Invasive Mould Infection

04/21/2026

– Turletricin Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA – – Elion to Present Turletricin Clinical Data at ESCMID Global – Excerpt from the Press Release: BOSTON, April 15, 2026 (GLOBE NEWSWIRE) — Elion Therapeutics, a biotechnology company dedicated to transforming the treatment of life-threatening fungal infections, today announced the…