Aug. 13, 2025 -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability. This designation positions CELZ-201-DDT among a select group of th

At extended median follow-up of 19.7 months, median overall survival (“OS”) increased from 16.33 to 28.94 months Clinical efficacy correlated with the magnitude of T cell responses specific to mutant-KRAS (“mKRAS”) induced by ELI-002 77% reduction in the risk of death and 88% reduction in the risk of relapse, associated with T cell responses above the threshold for anti-tumor efficacy ELI-002 induced both CD4+ and CD8+ mKRAS-specific T cell responses in most patients, and evidence of antigen-spr

In a gold-standard model of obesity, treatment with ARD-201 resulted in approximately 19% body weight reduction after 30 days of treatment. ARD-201 was also associated with attenuated weight regain after discontinuation of tirzepatide. In combination with low-dose tirzepatide, ARD-201 improved weight loss compared to high dose tirzepatide alone. Aardvark plans two separate Phase 2 clinical trials for ARD-201: Phase 2 POWER trial to focus on weight rebound in patients discontinuing GLP-1RA therap

Aug. 12, 2025 -- AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AAVB-039, the company’s gene therapy program for Stargardt disease secondary to biallelic mutation in ABCA4. The Investigational New Drug (IND) application for AAVB-039 was cleared to proceed by the FDA. Stargardt disease is the most

• First Patient Dosing Expected in Q1 2026 • Clinical Trial to Prioritize Biomarker-Selected RBM39-Dependent Cancers Aug. 11, 2025 -- SEED Therapeutics, Inc. (“SEED”), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ST-01156. The clearance enables initiation of a first-in-human Phase 1 c

Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd Aug. 11, 2025 -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that enrollment in the planned Phase 1b dose expansion cohorts evaluating givastomig, a bispecific Clau

Aug. 11, 2025 -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced selection of a novel modified release oral formulation for enobosarm, a selective androgen receptor modulator, for chronic weight loss management, following confirmation of pharmacokinetic endpoints in a clinical study. The single dose, open label pilot study evaluated the plasma co

Aug. 11, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA). Multiple System Atrophy is an unme

FibroGen has reached agreement with the FDA on important design elements for a pivotal Phase 3 clinical trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Company intends to file the Phase 3 protocol in the fourth quarter of 2025 Aug. 07, 2025 -- FibroGen, Inc. (NASDAQ: FGEN) today announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadusta

CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP. CT-155 is an investigational prescription digital therapeutic being evaluated to target negative symptoms of schizophrenia in a registrational randomized clinical trial.1,2 Often underappreciated and less recognized, negative symptoms impact more than half of people living with schizophrenia.3 Boehringer Ingelheim and Click Thera