Breakthrough Therapy

A New Dawn for Psychedelics: Compass Pathways Nears Major Phase 3 Psilocybin Results

2 weeks ago talkbio0Tagged Breakthrough Therapy, COMP360, Compass Pathways, mental health innovation, Psilocybin, psychedelic therapy, treatment-resistant depression, United States Food and Drug Administration

Compass Pathways; COMP360; psilocybin; treatment-resistant depression; phase 3 trial; psychedelic therapy; FDA Breakthrough Therapy; mental health innovation

Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program

4 months ago talkbio0Tagged AML, Breakthrough Therapy, DNA Sequence Rearrangement, Identifier, KMT2A gene, KOMET-001, KOMET-017, Leukemia, Myelocytic, Acute, Menin Inhibitor, Mutation, NPM1, NPM1 gene, Phase 3 trials, Ziftomenib

Ziftomenib, Acute Myeloid Leukemia (AML), NPM1 mutation, KMT2A rearrangement, Phase 3 trials, KOMET-001, KOMET-017, Menin inhibitor, Breakthrough Therapy Designation

FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

6 months ago talkbio0Tagged ADRIATIC, Approved, Breakthrough Therapy, durvalumab, Identifier, Imfinzi, Limited-stage, LS-SCLC, Phase 3 Clinical Trials, Priority Review, Systemic Immunotherapy, United States Food and Drug Administration

Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review

Cybin’s Psychedelic Breakthroughs: Advancing Mental Health Treatments

7 months ago talkbio0Tagged Breakthrough Therapy, Clinical Trials, Cybin, Hallucinogens, Identifier, mental health, N,N-Dimethyltryptamine, Psilocybin, United States Food and Drug Administration

Cybin, psychedelic therapeutics, mental health treatments, deuterated psilocybin, deuterated DMT, clinical trials, FDA Breakthrough Therapy Designation.