The U.S. Food and Drug Administrationlifted a clinical hold on Audentes Therapeutics’ ASPIRO trial studying AT132 as a potential treatment for X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease.
The U.S. Food and Drug Administration placed a clinical hold on patient enrollment and dosing in an early-stage trial of the Bellicum Pharmaceuticals’ cancer treatment BPX-601, after the death of a patient.
Shares of Voyager Therapeutics were down in trading after the company announced a clinical hold was placed on an experimental gene therapy treatment for Huntington’s disease before heading into the clinic.
Shares of Inovio Pharmaceuticals plunged in trading after the company reported the U.S. Food and Drug Administration placed a partial clinical hold on the planned Phase II/III study of the Covid-19 vaccine candidate INO-4800.
A third pediatric patient involved in a gene therapy trial for a rare, neuromuscular disease conducted by Audentes Therapeutics died.
The U.S. Food and Drug Administration placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for Covid-19 over what was described as a lack of robust data supporting its use.
Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment ran into a roadblock in the form of a clinical hold.
Shares of LogicBio plunged more than 25 percent after the company disclosed that the U.S. Food and Drug Administration placed a clinical hold on the proposed gene therapy treatment for methylmalonic acidemia (MMA).
Ipsen decided to temporarily pause dosing in the company’s palovarotene extension studies for patients with fibrodysplasia ossificans progressiva following a recommendation from an Independent Data Monitoring Committee.
Bellicum Pharmaceuticals Inc. said the FDA placed a clinical hold on U.S. trials of the company’s experimental cancer drug after three cases of brain disease linked to head trauma.