Astellas writes down another piece of its Audentes gene therapy acquisition
The FDA has handed a boost to Astellas Pharma’s stuttering push into gene therapy by lifting the clinical hold on a phase 1/2 study in late-onset Pompe disease (LOPD). Astellas was forced to pump the brakes on the AT845 program last year after a participant developed peripheral sensory neuropathy.
Astellas paid $3 billion to snap up biotech Audentes Therapeutics in 2019 but is still paying for the biotech more than a year down the line.
Following its acquisition last year by Astellas Pharma, Audentes Therapeutics now has become Astellas Gene Therapies.
Natalie Holles, the chief executive of Audentes Therapeutics, has departed the company as the gene therapy developer's new owner Astellas Pharma fully folds the biotech into its larger organization.
Japanese pharma Astellas and its new biotech buyout Audentes got a Christmas gift from the FDA when the agency lifted a clinical hold on its gene therapy.
Japanese pharma Astellas and its new biotech buyout Audentes got a Christmas gift from the FDA when the agency lifted a clinical hold on its gene therapy.
Taysha Gene Therapies, a patient-centric gene therapy company with a mission to eradicate monogenic CNS disease, today announced the appointment of its executive leadership team. This group has significant experience in gene therapy drug development and commercialization, and will enable Taysha to build the corporate culture and infrastructure necessary to advance its extensive pipeline of 18 gene therapy programs, with exclusive options to acquire four additional programs from UT Southwestern Gene Therapy Program. In addition, Sukumar Nagendran, M.D., former Chief Medical Officer of AveXis, and Phillip Donenberg, former Chief Financial Officer of AveXis, have joined the company’s Board of Directors. Mr. Donenberg will also serve as the company’s Audit Committee Chairman.
Audentes Therapeutics has reported a third death in a clinical trial of its gene therapy against a rare genetic neuromuscular disorder. The Astellas Pharma subsidiary said it “remains committed” to the program despite the rising death rate in the higher-dose cohort of the phase 1/2 clinical trial.
Audentes Therapeutics Inc, an Astellas company, announced that a third study patient has passed away in the ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy (XLM), which is a serious, life threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death. Preliminary findings indicate that the immediate cause of death was gastrointestinal bleeding.