Phase II
RSV, influenza, COVID-19 and monkeypox have dominated vaccine discussions this year, but vaccines are also being developed for a host of other infectious diseases.
Beam Therapeutics has enrolled the first patient in a Phase I/II trial studying a gene therapy leveraging base editing in adults with severe sickle cell disease.
Stoke Therapeutics is gearing up for a pivotal trial of its lead program for a rare genetic epilepsy disease and announced positive results from its Phase I/IIa study in children with Dravet syndrome.
An anti-CD70 antibody drug conjugate developed by Ambrx, Inc. has been administered to the first patient in a Phase I study in China. It marks the first ADC in active development that targets CD70.
Oncolytics Biotech released data Thursday from a Phase I/II study in pancreatic ductal adenocarcinoma that support plans to advance the program into Phase III.
GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses.
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
AbbVie’s investigational neurotoxin, designed to prevent postoperative atrial fibrillation, missed the primary endpoint in a Phase II trial, the company announced Monday.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Biopharma’s efforts to conquer immunoglobulin A nephropathy were on full display at ASN’s Kidney Week as Ionis, Chinook and Vera all reported positive data.
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