September 2025 – Page 6

Neurocrine Biosciences Reports Positive Phase 2 Results for Osavampator in Major Depressive Disorder

4 weeks ago talkbio0Tagged adjunctive treatment, AMPA-PAM, Biosciences, Clinical Research, Clinical Trials, Mental Depression, Neurocrine, osavampator, safety profile, SAVITRI

Neurocrine Biosciences; osavampator; Phase 2 results; major depressive disorder; AMPA-PAM; SAVITRI study; clinical trial; adjunctive treatment; depression; safety profile

Bristol Myers Squibb to Launch Schizophrenia Drug Cobenfy in UK at US Price

4 weeks ago talkbio0Tagged Antipsychotic Agents, Cholinergic Receptors, Cobenfy, drug price, launch, Myers, Nance-Horan syndrome, Prices, Schizophrenia, squibb, U.S., UK

Bristol Myers Squibb; Cobenfy; schizophrenia; UK launch; drug pricing; US list price; NHS; cholinergic receptors; antipsychotic; 2026

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

4 weeks ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

4 weeks ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial

4 weeks ago talkbio0Tagged advanced breast cancer, Clinical Research, ER-positive, giredestrant, Hormone Therapy, Malignant neoplasm of breast, Oral SERD, Phase 3 Clinical Trials, Progression-Free Survival, Roche (company)

Roche; oral SERD; giredestrant; progression-free survival; pivotal study; breast cancer; ER-positive; endocrine therapy; Phase III trial; advanced breast cancer

AstraZeneca and SOPHiA GENETICS Expand AI-Powered Cancer Testing Collaboration

4 weeks ago talkbio0Tagged Artificial Intelligence, AstraZeneca, cancer testing, High-Throughput Nucleotide Sequencing, Malignant neoplasm of breast, Malignant neoplasm of prostate, PIK3CA/AKT1/PTEN pathway, Precision Medicine, real-world evidence, SOPHiA GENETICS

AstraZeneca; SOPHiA GENETICS; AI; cancer testing; breast cancer; prostate cancer; next generation sequencing (NGS); PIK3CA/AKT1/PTEN pathway; real-world evidence; precision medicine

Parkinson’s Patients Prefer Medtronic’s Adaptive Brain Stimulation Over Traditional Settings, Major Study Shows

4 weeks ago talkbio0Tagged ADAPT-PD study, adaptive deep brain stimulation, aDBS, Approved, Deep Brain Stimulation, Medtronic, Parkinson 's disease, personalized neuromodulation, real-time brain monitoring, United States Food and Drug Administration

Parkinson’s disease; adaptive deep brain stimulation; aDBS; Medtronic; ADAPT-PD study; FDA approval; DBS; personalized neuromodulation; real-time brain monitoring

FDA Approves Stealth BioTherapeutics’ Forzinity as First Treatment for Barth Syndrome After Rejection and Delay

4 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Abnormality of mitochondrial metabolism, Accelerated, Approved, Elamipretide, Forzinity, Infrequent, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; rare disease; mitochondrial dysfunction; accelerated approval

CDC Advisors Shift COVID-19 Vaccine Guidance to Individual Decision-Making

4 weeks ago talkbio0Tagged ACIP, Centers for Disease Control and Prevention (U.S.), Consultation, COVID19 (disease), individual choice, Provider, Recommendation, Vaccines

CDC; COVID-19 vaccine; vaccine recommendation; individual choice; ACIP; provider consultation

FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity, the First Treatment for Barth Syndrome

4 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Clinical Trials, Elamipretide, Forzinity, Infrequent, Mitochondrial Diseases, Pediatric Disorder, Stealth BioTherapeutics, United States Food and Drug Administration

FDA approval; Stealth BioTherapeutics; Forzinity; elamipretide; Barth syndrome; mitochondrial disease; accelerated approval; rare disease; pediatric disease; clinical trial