Clinical Trial News Archive - September 2023
September 1, 2023
- First Patient with Chronic Hepatitis B Dosed with ISA104 in First-in-Human Phase 1 Study
- 23andMe Granted New FDA Clearance to Report Additional BRCA Variants
September 4, 2023
September 5, 2023
September 6, 2023
- NIH Investigates Multidrug-Resistant Bacterium Emerging in Community Settings
- Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
September 7, 2023
- DS-3939 Enters Clinical Development in Patients Across Several Types of Advanced Solid Cancers
- Bryostatin-1 Shows Statistically Significant Results as an ALS Treatment in Pre-Clinical Independent Study
September 8, 2023
September 9, 2023
- Bristol Myers Squibb’s Investigational LPA1 Antagonist BMS-986278 Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase 2 Study
- SciSparc Announces Initiation of Randomized Phase IIb Clinical Trial of its Proprietary SCI-110 for Tourette Syndrome
September 10, 2023
- Datopotamab Deruxtecan Plus Durvalumab Showed Promising Clinical Activity in the First-Line Advanced Non-Small Cell Lung Cancer Setting in TROPION-Lung04 Phase 1b Trial
- Patritumab Deruxtecan Demonstrated Clinically Meaningful and Durable Responses in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer in HERTHENA-Lung01 Phase 2 Trial
- Ifinatamab Deruxtecan Continues to Demonstrate Durable Responses in Patients with Advanced Small Cell Lung Cancer in Early Trial
- Supernus Announces New Qelbree Data Showing Improvement in ADHD Symptom
September 11, 2023
- ACELYRIN, INC. Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa
- Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)
- Takeda Announces Positive Topline Results from Phase 2b Study Evaluating TAK-279, a Highly Selective Oral TYK2 Inhibitor, for the Treatment of Active Psoriatic Arthritis
- ACELYRIN, INC. Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa
- First Dose Cohort completed and Second Dose Cohort Opened for B-cell Non-Hodgkin Lymphoma Phase 1 Clinical Trial of PMB-CT01
- Biosyngen received FDA approval for Phase I/II Clinical Trials for BRL03, targeting Lung Cancer, Gastric Cancer and other advanced Solid Tumors
September 13, 2023
September 14, 2023
September 15, 2023
- NeuroBo Pharmaceuticals Doses First Patient in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH
- NIH Clinical Trial of Universal Flu Vaccine Candidate FluMos-v2 Begins
September 16, 2023
September 18, 2023
- Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)
- Kymera Therapeutics Receives U.S. FDA Fast Track Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Relapsed/Refractory Cutaneous T-Cell Lymphoma and Relapsed/Refractory Peripheral T-Cell Lymphoma
- Peer-Reviewed Publication of Positive Preclinical Data of SiSaf’s SIS-ADO2 siRNA Program to Treat Rare Genetic Bone Disorder Osteopetrosis
- Higher Buprenorphine Doses Associated with Improved Retention in Treatment for Opioid Use Disorder
September 20, 2023
- Clinical Trial of HIV Vaccine Begins in United States and South Africa
- Researchers Discover Biomarker for Tracking Depression Recovery
- Researchers Develop New Method to Identify Potential Stroke Therapies
- Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive Disorder
- Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera
September 21, 2023
- U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
- Leucid Bio Granted MHRA Clinical Trial Authorisation for Lateral NKG2D CAR-T Cell Therapy LEU011
- Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer
September 22, 2023
- Clinical Trial to Test Immune Modulation Strategy for Hospitalized Covid-19 Patients Begins
- Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
September 25, 2023
September 26, 2023
- NMD Pharma initiates Phase II trial of NMD670 in Spinal Muscular Atrophy
- Tiziana Life Sciences Initiates Multi-Center Phase 2a Clinical Trial of Intranasal Foralumab for Non-Active Secondary Progressive Multiple Sclerosis
September 27, 2023
- IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer
- Gracell Biotechnologies Reports Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent Complete Response Rate
- BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
September 28, 2023
- Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors
- First Patient Dosed in Phase 1b Clinical Trial of Synthekine’s α/β Biased IL-2, STK-012, for Treatment of Solid Tumors
- ImmunoGenesis Doses First Patient in Phase 1a/1b Clinical Trial of IMGS‑001 in Relapsed or Refractory Advanced Solid Tumors
September 29, 2023
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