Clinical Trial News Archive - February 2025
February 3, 2025
February 5, 2025
- Kura Oncology and Kyowa Kirin Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs
- Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement
- EyePoint Announces Positive Six-Month Results for the Phase 2 VERONA Clinical Trial of Duravyu for Diabetic Macular Edema Meeting Primary and Secondary Endpoints
- Annovis Announces First Patients Entered into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease
- Arbor Biotechnologies Announces FDA Orphan Drug and Rare Pediatric Disease Designations Granted to ABO-101 for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
- Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil (Gemogenovatucel-T): An Investigational Personalized Immunotherapy for Advanced Ovarian Cancer
February 6, 2025
- Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
- U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy
- Sangamo Therapeutics Announces Updated Phase 1/2 STAAR Study Data for Isaralgagene Civaparvovec in Fabry Disease
- Bracco Imaging Receives FDA Fast Track Designation for BR55
- Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian Cancer
- Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
- Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus
February 7, 2025
- Pliant Therapeutics Provides Update on BEACON-IPF, a Phase 2b/3 Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis
- Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human
February 10, 2025
- Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of Qtorin 3.9% Rapamycin Anhydrous Gel (Qtorin rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include the Younger Pediatric Population, Children 3 to 5 Years Old
- Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
- Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
- Boehringer’s Nerandomilast Meets Primary Endpoint in Phase III Study FIBRONEER™-ILD, in Progressive Pulmonary Fibrosis
February 11, 2025
- Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity
- NIH-Funded Clinical Trial Will Evaluate New Dengue Therapeutic
- Single Dose of Broadly Neutralizing Antibody Protects Macaques from H5N1 Influenza
February 12, 2025
February 13, 2025
February 17, 2025
- Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer
- Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome
February 18, 2025
February 19, 2025
- Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung Cancer
- Clarity Receives US FDA Fast Track Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer Patients with Cu-67 SAR-bisPSMA
February 20, 2025
February 24, 2025
February 25, 2025
February 26, 2025
- Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer
- Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs
- Camizestrant Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in 1st-Line Advanced HR-Positive Breast Cancer with an Emergent ESR1 Tumor Mutation in SERENA-6 Phase III Trial
February 27, 2025
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