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Following the regulator’s administrative complaint and threat of a lawsuit in federal court, Sanofi has decided to terminate its licensing deal with Maze Therapeutics to avoid a long litigation process.
The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease.
The Indiana-based pharma shed shares after a study published Monday in JAMA showed “substantial” weight gain after patients discontinued treatment with the GLP-1 receptor agonist.
The company’s fiscal report for 2023 details revenue losses of $539 million and layoffs of 1,100 employees but notes that future GLP-1 manufacturing revenues could help stabilize its finances.
A CAR-T cell therapy for autoimmune diseases generated significant attention at the 2023 American Society of Hematology (ASH) annual meeting and Arcellx and Seagen posted promising data.
The New York-based pharma reported at ASH that odronextamab had an 80% objective response rate, with 73% of patients experiencing a complete response.
Patients treated with the investigational sickle cell therapy saw an increase in hemoglobin levels and improved red blood cell parameters.
The investigational allogeneic CAR-T therapy P-BCMA-ALLO1 appears to be more effective following strong immunosuppressive preconditioning.
These factors, along with bluebird bio’s failure to receive a priority review voucher, all hurt the company’s stock price following Lyfgenia’s approval.
Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.