News about "clinical-stage biotechnology company"

Avacta Reports Early Clinical Validation of AVA6103 in FOCUS-01 Trial

Avacta’s early FOCUS-01 data provide clinical validation for AVA6103 and support further evaluation of its pre|CISION tumour-activated PDC platform.

Clinical-stage Biotechnology Company | 21/09/2026 | By News Bureau |  972

Longeveron's Laromestrocel Trial Misses Primary Endpoint in HLHS

Longeveron’s investigational stem cell therapy laromestrocel did not meet the primary efficacy endpoint in the Phase 2b ELPIS 2 trial evaluating infants with hypoplastic left heart syndrome.

Clinical-stage Biotechnology Company | 21/09/2026 | By News Bureau

Rezubio Advances RZ-520 Into Phase 1 Trial Following FDA and NMPA Clearances

Rezubio has dosed the first cohort in a Phase 1 trial evaluating RZ-520, an investigational inhaled therapy for chronic respiratory diseases.

Clinical-stage Biotechnology Company | 08/09/2026 | By News Bureau

Acepodia Receives FDA Clearance for ACE723 ADC in Advanced Liver Cancer

Acepodia’s ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumour cells in patients with unresectable or metastatic hepatocellular carcinoma.

Clinical-stage Biotechnology Company | 07/09/2026 | By News Bureau |  115

FDA Clears Graviton BioScience's GV101 for Phase 2 Development in Friedreich's Ataxia

Graviton BioScience has received FDA IND clearance for a new GV101 capsule formulation, paving the way for a Phase 2 trial in patients with Friedreich’s ataxia.

Clinical-stage Biotechnology Company | 12/08/2026 | By News Bureau |  406

4Moving Biotech Completes Enrollment in Phase 2a Trial of Investigational Knee Osteoarthritis Therapy

4Moving Biotech has completed patient enrollment in its global Phase 2a INFLAM MOTION trial, assessing the safety and efficacy of investigational therapy 4P004 for inflammatory knee osteoarthritis.

Clinical-stage Biotechnology Company | 05/08/2026 | By News Bureau |  1431

Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review

FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.

Clinical-stage Biotechnology Company | 22/07/2026 | By News Bureau |  133

Can-Fite BioPharma Secures Australian Patent for Namodenoson in Advanced Metastatic Cancer

Can-Fite BioPharma has secured an Australian patent covering the use of Namodenoson for advanced metastatic cancer, strengthening intellectual property protection as the drug advances through late-stage clinical development for liver and pancreatic cancers.

Clinical-stage Biotechnology Company | 15/07/2026 | By News Bureau |  137

Immunomic Therapeutics Doses First Patient in Phase 1 Trial of Japanese Cedar Allergy Vaccine

Immunomic Therapeutics has initiated Phase 1 clinical testing of ITI-9001 after dosing the first participant in Japan, advancing the development of a next-generation therapeutic vaccine for Japanese cedar pollen allergy.

Clinical-stage Biotechnology Company | 06/07/2026 | By News Bureau |  143

INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate

INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.

Clinical-stage Biotechnology Company | 03/07/2026 | By News Bureau |  285