Breakthrough Therapy

Daiichi and Merck’s Lung Cancer ADC Achieves 48% Response Rate in Pivotal Trial

3 days ago talkbio0Tagged Accelerated, Antibody-Drug Conjugates, Approved, Breakthrough Therapy, CD276 gene, Co., Daiichi, Deruxtecan, Frequency of Responses, IDeate-Lung01, Identifier, ifinatamab, Overall Survival, Progression-Free Survival, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

Daiichi Sankyo; Merck & Co.; ifinatamab deruxtecan; I-DXd; B7-H3; antibody-drug conjugate; ADC; small cell lung cancer; SCLC; IDeate-Lung01; objective response rate; accelerated approval; progression-free survival; overall survival; FDA Breakthrough Therapy Designation

Bausch Health to Acquire DURECT and Breakthrough Liver Disease Candidate Larsucosterol for $63M Upfront

1 month ago talkbio0Tagged Acquisition, Bausch Health, Breakthrough Therapy, Dosage Forms, DURECT, epigenetic modulator, Hepatitis, Alcoholic, Larsucosterol, Liver diseases, milestone payments, United States Food and Drug Administration

Bausch Health; DURECT; larsucosterol; liver disease; alcoholic hepatitis; epigenetic modulator; FDA Breakthrough Therapy; acquisition; pharmaceutical; milestone payments

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

4 months 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

7 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

9 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

10 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.