ENTITY – Page 5

Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline

1 week ago talkbio0Tagged AERIFY-1, AERIFY-2, Approved, Clinical Trials, COPD, IL33 protein, human, itepekimab, Regeneron, sanofi, United States Food and Drug Administration

Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results

Keros Therapeutics Halts Pulmonary Hypertension Drug After Safety Issues, Cuts 45% of Workforce

1 week ago talkbio0Tagged biotech sector, cibotercept, drug development halt, Financial cost, Financial savings, layoffs, PAH, Pericardial effusion, Pulmonary arterial hypertension

Keros Therapeutics; cibotercept; pulmonary arterial hypertension; PAH; layoffs; pericardial effusion; drug development halt; cost savings; biotech sector

Analysts Downplay Intellia Adverse Event, but Gene Therapy Safety Remains Under Scrutiny

1 week ago talkbio0Tagged Adverse event, ATTR-CM, Event, Gene Modification, gene therapy, Intellia, liver transaminase, MAGNITUDE trial, Response process, Safety, Stock Decline

Intellia Therapeutics; gene therapy; safety event; adverse event; MAGNITUDE trial; liver transaminase; stock decline; ATTR-CM; gene editing; analyst response

Trump Administration Cancels Major Federal Funding for Moderna’s Bird Flu Vaccine

1 week ago talkbio0Tagged Administration occupational activities, bird flu vaccine, cancellation, CHARGE Syndrome, H5 avian influenza, HHS, Moderna, mRNA Vaccine, pandemic preparedness, Transplant Registry Unified Management Program

Trump administration; Moderna; bird flu vaccine; HHS; funding cancellation; mRNA vaccine; pandemic preparedness; H5 avian influenza

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

1 week ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

1 week ago talkbio0Tagged Application procedure, Clinical Trials, Daiichi, Deruxtecan, HER3, Merck, Non-Small Cell Lung Carcinoma, Overall Survival, patritumab, Sankyo, therapeutic autologous dendritic cells, United States Food and Drug Administration, Withdraw (activity)

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal

iTeos to Shut Down Operations After TIGIT Therapy Setback

1 week ago talkbio0Tagged asset, belrestotug, Clinical trial failure, ENT1, EOS-215, EOS-984, Exit, Failure (biologic function), immuno-oncology, iTeos, Obesity, Programs - Publication Format, Sales - occupational activity, SmithKline Beecham, TIGIT gene

iTeos Therapeutics; TIGIT failure; GSK exit; clinical trial failure; belrestotug; asset sale; immuno-oncology; EOS-984; EOS-215; ENT1 obesity program

Uncertainty Surrounds Moderna’s Next-Generation COVID Shot Amid Policy Changes

2 weeks ago talkbio0Tagged COVID19 (disease), flu/COVID-19, Moderna, Policy, Recommendation, Regulatory Setback, United States Food and Drug Administration, vaccine access, Vaccines

Moderna; COVID-19 vaccine; FDA policy; combination flu/COVID-19 shot; vaccine access; mRNA-1083; vaccine recommendations; regulatory setback

GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero’s Stock Surges

2 weeks ago talkbio0Tagged Antibiotics, Clinical Trials, Complicated, HBr, PIVOT-PO trial, SmithKline Beecham, Spero Therapeutics, Stock Surge, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; Phase 3 trial; UTI antibiotic; complicated urinary tract infection; PIVOT-PO trial; stock surge; clinical trial results; FDA submission

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

2 weeks 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