Chi-Med’s surufatinib approved in ChinaChina’s National Medical Products Administration (NMPA) approved an NDA from Hutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) for Sulanda surufatinib to treat non-pancreatic neuroendocrine tumors. The FGFR, VEGFR and CSF1R inhibitor is...

The report of a second patient death in a trial of an AAV8-based gene therapy from Audentes and Astellas renewed decades-old concerns over the modality’s safety, but the adverse events may reflect a need for...

Dynacure expects its €50 million ($55.4 million) series C round to fund an ongoing trial of its lead program for myotubular and centronuclear myopathies in adults, as well as a planned pediatric study. Together, the...

Audentes presented updated data from the Phase I/II ASPIRO trial of AT132 to treat X-linked myotubular myopathy (XLMTM) showing that the trial's low and high doses had comparable safety and efficacy profiles. Chairman and CEO...

Audentes partnered with Nationwide Children's Hospital to develop antisense oligonucleotides delivered with the biotech's adeno-associated viral (AAV) vectors to treat muscular dystrophies. Audentes Therapeutics Inc. (NASDAQ:BOLD) Chairman and CEO Matt Patterson told BioCentury the decision...

Whether or not to bring manufacturing in-house for gene therapy companies is becoming a critical choice, as contract manufacturers struggle to keep up with demand. The trade-off for the upfront investment risk is control over...

On the heels of data for one of its gene therapies, Audentes Therapeutics Inc. (NASDAQ:BOLD) raised $150.8 million on Oct. 10 through the sale of 5.2 million shares at $29 in a follow-on underwritten by...

On the heels of data for one of its gene therapies, Audentes Therapeutics Inc. (NASDAQ:BOLD) raised $150.8 million Wednesday through the sale of 5.2 million shares at $29 in a follow-on underwritten by BofA Merrill...

Audentes Therapeutics Inc. (NASDAQ:BOLD) reported data from its 24-week muscle biopsy analyses of the first dose cohort and said an IDMC recommended proceeding to the second dose cohort of the Phase I/II ASPIRO trial evaluating...

Audentes Therapeutics Inc. (NASDAQ:BOLD) reported updated interim data from the first cohort of the open-label, dose-escalation, U.S. Phase I/II ASPIRO trial testing AT132 in patients with X-linked myotubular myopathy (XLMTM). The presentation at the American...