Breakthrough Therapy

Genmab CEO on the $8B Acquisition of Merus: Strategy Behind the ‘Very Fair’ Deal and Plans to Polish a Rough Diamond

4 weeks ago talkbio0Tagged Acquisition, Antibodies, Bispecific, Breakthrough Therapy, Cancer of Neck, CEO, expansion, Genmab, Head, Merus, Neoplasms, Perspective, Petosemtamab, pipeline, United States Food and Drug Administration

Genmab; Merus; petosemtamab; acquisition; oncology; head and neck cancer; bispecific antibody; FDA Breakthrough Therapy; pipeline expansion; biotech; $8B deal; CEO perspective

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

1 month ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

2 months ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

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

2 months 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

3 months 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

5 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

9 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

11 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

11 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.