Disease or Syndrome

Metsera Calls Pfizer’s Threats ‘Nonsense’ as Rift Between Companies Widens

6 hours ago talkbio0Tagged Chancery, Delaware Court, drug acquisition, Litigation, Merger, Metsera, Novo Nordisk, Obesity, Pfizer, regulatory approval

Metsera; Pfizer; Novo Nordisk; merger dispute; litigation; obesity drug acquisition; regulatory approval; Delaware Court of Chancery

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

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

4 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

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

4 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

Otsuka Acquires Asia-Pacific Rights to 4D Molecular Therapeutics’ Retinal Gene Therapy 4D-150 for $85 Million

4 days ago talkbio0Tagged 4D Molecular Therapeutics ', Asia-Pacific, gene therapy, Macular edema due to diabetes mellitus, Ophthalmology specialty, Otsuka, strategic partnership, Wet Age-Related Macular Degeneration

Otsuka; 4D Molecular Therapeutics; 4D-150; Asia-Pacific rights; gene therapy; wet age-related macular degeneration; diabetic macular edema; $85 million; strategic partnership; ophthalmology

Researchers Publish Roadmap of FDA Interactions After Baby KJ’s Groundbreaking Gene Editing Therapy, as FDA Signals New Pathway for Patient-Specific Treatments

4 days ago talkbio0Tagged approval pathway, Baby KJ, CPS1 deficiency, CRISPR gene editing, Disease Gene Therapies, Infrequent, N-of-1 therapies, platform trials, Precision Medicine, Rare Diseases, regulatory roadmap, United States Food and Drug Administration

Baby KJ; CRISPR gene editing; CPS1 deficiency; FDA approval pathway; personalized medicine; rare disease; regulatory roadmap; platform trials; N-of-1 therapies; rare disease gene therapies

Wave Life Sciences Obesity Biomarker Data Raise Hopes for Future Readouts

4 days ago talkbio0Tagged Activin E :* *, Biological Markers, Body Composition, Clinical Trials, INHBE gene, INLIGHT trial, Obesity, RNA therapeutics, RNA, Small Interfering, Wave Life Sciences, Weight Loss, WVE-007

Wave Life Sciences; WVE-007; obesity; biomarker data; siRNA; Activin E; INHBE gene; RNA therapeutics; clinical trial; body composition; weight loss; INLIGHT trial

FDA Places Clinical Hold on Two Intellia CRISPR Trials After Life-Threatening Liver Toxicity Case

4 days ago talkbio0Tagged ATTR-CM, ATTR-PN, Clustered Regularly Interspaced Short Palindromic Repeats, gene therapy, Intellia, Liver, MAGNITUDE trial, Nexiguran, Senile cardiac amyloidosis, Study on Hold, Toxicity aspects, United States Food and Drug Administration, ziclumeran

FDA; Intellia; CRISPR; clinical hold; liver toxicity; nexiguran ziclumeran; MAGNITUDE trial; transthyretin amyloidosis; ATTR-CM; ATTR-PN; gene therapy

ChemDiv’s Discovery Platform Enables Differentiated, Reversible Pan-EGFR Kinase Inhibitors for GFR-Mutant Lung Cancer

4 days ago talkbio0Tagged Candidiasis, Chronic Mucocutaneous, ChemDiv, Discovery Platform, Drug Design, Epidermal Growth Factor Receptor, Kinase Inhibitors [MoA], Kinome, lead-optimization, Non-Small Cell Lung Carcinoma, Pan-EGFR Inhibitors, Readiness, selectivity, Wild-Type EGFR Sparing

ChemDiv; Discovery Platform; EGFR; Reversible Pan-EGFR Inhibitors; NSCLC; Kinase Inhibitors; Wild-Type EGFR Sparing; Kinome Selectivity; AI-Guided Drug Design; CMC Readiness; Lead Optimization

Regeneron and ModeX Forge Potential $1 Billion+ Collaboration to Develop Multispecific Antibody Drugs

5 days ago talkbio0Tagged Biotechnology, Collaboration, Immunology, Metabolic Diseases, milestone payments, ModeX, MSTAR, multispecific antibodies, Neoplasms, OPKO Health, Regeneron, upfront payment

Regeneron; ModeX Therapeutics; multispecific antibodies; MSTAR platform; biotechnology deal; upfront payment; milestone payments; immunology; oncology; metabolic diseases; collaboration; OPKO Health