Functional Concept – Page 3

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

1 month ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

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

1 month 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

iTeos to Shut Down Operations After TIGIT Therapy Setback

1 month 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

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

1 month 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

Sernova Chair Resigns After Insider Trading Indictment Tied to Novartis-Chinook Deal

1 month ago talkbio0Tagged biotherapeutics, DOJ, indictment, insider trading, News [Publication Type], Novartis-Chinook acquisition, resignation, Ross Haghighat, securities fraud, Sernova

Sernova Biotherapeutics; insider trading; resignation; Ross Haghighat; Novartis-Chinook acquisition; securities fraud; biotech news; DOJ indictment

Patient Death in Rocket Pharmaceuticals Gene Therapy Trial Prompts FDA Clinical Hold

1 month ago talkbio0Tagged acute systemic infection, Adverse event, Capillary Leak Syndrome, gene therapy, Glycogen Storage Disease Type IIb, Patient Death, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; FDA; patient death; capillary leak syndrome; acute systemic infection; RP-A501; adverse event