Intellia Therapeutics Advances In Vivo CRISPR Therapy Lonvo-z to FDA After Positive Phase 3 HAELO Trial Results on April 27, 2026 Angioedemas, Hereditary Clustered Regularly Interspaced Short Palindromic Repeats Gene Modification in vivo Intellia lonvo-z Phase 3 HAELO submission United States Food and Drug Administration +
Compass Pathways Stock Soars on Second Phase 3 Success for Psilocybin Depression Treatment on February 17, 2026 COMP360 Compass Pathways Phase 3 trial Psilocybin Stock Surge submission treatment-resistant depression United States Food and Drug Administration +
Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST) on November 11, 2025 bezuclastinib Clinical Trials Cogent Biosciences Frequency of Responses Gastrointestinal Stromal Tumors NDA Phase 3 Progression-Free Survival Standard (qualifier) Stock Surge submission sunitinib +
Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart on October 24, 2025 Anti-DR5 Agonistic Monoclonal Antibody INBRX-109 Chondrosarcoma Inhibrx Malignant Bone Neoplasm ozekibart Progression-Free Survival submission United States Food and Drug Administration +
Exelixis' Kinase Blocker Zanzalintinib Sets New Survival Standard in Third-Line Metastatic Colorectal Cancer, Paving Way for FDA Review on October 21, 2025 Colorectal Carcinoma Exelixis kinase inhibitor [EPC] Overall Survival regorafenib STELLAR-303 trial submission Tecentriq Third line treatment United States Food and Drug Administration zanzalintinib +
Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million on October 13, 2025 Child Fund Raising Idorsia Indonesian language Muscular Dystrophy, Duchenne oral small-molecule therapy Phase 2 clinical trial SAT-3247 Satellos submission United States Food and Drug Administration +
Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA on September 11, 2025 Approved Avidity Biosciences Blackfoot language Breakthrough Therapy Clinical Trials Functional improvements Muscular Dystrophy, Duchenne skipping submission United States Food and Drug Administration +
Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug on July 24, 2025 AD109 Apnimed aroxybutynin atomoxetine Clinical Trials LunAIRo oral drug Sleep Apnea, Obstructive submission SynAIRgy United States Food and Drug Administration +
Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned on June 25, 2025 ARROS-1 trial Frequency of Responses Non-Small Cell Lung Carcinoma Nuvalent Protein-tyrosine kinase inhibitor ROS1-positive Lung Cancer submission United States Food and Drug Administration zidesamtinib +
GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero's Stock Surges on May 28, 2025 Antibiotics Clinical Trials Complicated HBr PIVOT-PO trial SmithKline Beecham Spero Therapeutics Stock Surge submission United States Food and Drug Administration Urinary tract infection +
Merck's HIV Combo Treatment Advances Towards FDA Filing on March 13, 2025 DOR/ISL doravirine/islatravir once-daily oral regimen Phase 3 trials submission United States Food and Drug Administration viral suppression +
Kura Oncology and Kyowa Kirin Report Positive Phase 2 Results for Ziftomenib in AML, Prepare for FDA Submission on February 08, 2025 acute Kirin KOMET-001 Kura Oncology Kyowa Leukemia Myelocytic NPM1 NPM1-mutant Phase 2 trial submission United States Food and Drug Administration Ziftomenib +