November 2025 – Talk Bio

uniQure Faces Delay as FDA Walks Back Accelerated Approval for Huntington’s Gene Therapy

3 hours ago talkbio0Tagged Accelerated, AMT-130, Approved, Clinical Trials, gene therapy, Huntington 's disease, Regulatory Setback, UniQure, United States Food and Drug Administration

uniQure; AMT-130; Huntington’s disease; gene therapy; FDA; accelerated approval; regulatory setback; clinical trial

Roche Pays $55M Upfront to Manifold Bio in $2B+ Deal for AI-Guided Next-Gen Brain Shuttles

8 hours ago talkbio0Tagged AI drug discovery, BBB, Blood - brain barrier anatomy, Manifold Bio, milestones, Neurological diseases, research, Roche (company), shuttles, therapeutic payloads, upfront payment

Roche; Manifold Bio; blood-brain barrier; BBB shuttles; neurological diseases; AI drug discovery; research deal; upfront payment; milestones; therapeutic payloads

‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

12 hours ago talkbio0Tagged agency turmoil, Center for Drug Evaluation, Center for Drug Evaluation and Research, George Tidmarsh, Kevin Tang, Leadership, personal conduct probe, Regulatory Authority, research, resignation, United States Food and Drug Administration

FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority

Zag Bio Launches with $80M to Teach the Immune System to Make Better Tregs

3 days ago talkbio0Tagged AbbVie, Autoimmune Diseases, Diabetes Mellitus, Insulin-Dependent, Funding, Immune Tolerance, Regeneron, Regulatory T-Lymphocytes, sanofi, Series A, thymus-targeted therapy, Tregs, Zag Bio

Zag Bio; Tregs; regulatory T cells; autoimmune diseases; thymus-targeted therapy; Series A funding; immune tolerance; Type 1 diabetes; AbbVie; Regeneron; Sanofi

Expert Flags Potential ‘Honeymoon Effect’ as Rapport Heads Towards Phase III Epilepsy Trials

3 days ago talkbio0Tagged Biological Markers, drug-resistant focal seizures, Epilepsy, Honeymoon Effect, KOL Bulletin, mid-stage, Phase 3 Clinical Trials, RAP-219, Rapport Therapeutics, Seizures

KOL Bulletin; honeymoon effect; Rapport Therapeutics; RAP-219; Phase III trials; epilepsy; drug-resistant focal seizures; seizure reduction; mid-stage data; biomarker

Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook

3 days ago talkbio0Tagged Accelerated, Approved, Biological Markers, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, Effectiveness, Functional improvement, Muscular Dystrophy, Duchenne, regulatory approval, z-rostudirsen

Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval

ESMO 2025 KEYNOTE-671 Update: Perioperative Pembrolizumab Reinforces NSCLC Standard

3 days ago talkbio0Tagged ESMO Congress, Event-Free Survival, Immunotherapy, KEYNOTE-671, Keytruda, Non-Small Cell Lung Carcinoma, Overall Survival, pembrolizumab, perioperative, Standard of Care

KEYNOTE-671; pembrolizumab; KEYTRUDA; perioperative immunotherapy; NSCLC; overall survival; event-free survival; ESMO Congress; standard of care