The U.S. Food and Drug Administration has placed a clinical hold on Iovance Biotherapeutics’ lung cancer therapy trial after a patient death, the company said on Wednesday.
Tag Archive for: clinical hold
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
The FDA has placed a partial clinical hold on two of Innate Pharma’s trials assessing its investigational antibody lacutamab following one patient death, the company announced Thursday
Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns.
Following the death of a patient, the FDA has placed a clinical hold on Arcellx’s iMMagine-1 Phase II trial of its T cell therapy for relapsed or refractory multiple myeloma. The company’s stock fell around 23% in pre-market trading Tuesday.
Mersana Therapeutics said on Thursday the U.S. Food and Drug Administration (FDA) had paused enrollment in two studies of its ovarian cancer drug after five deaths in bleeding-related events, sending shares of the company tumbling.
The FDA has placed a clinical hold on PepGen‘s Phase I trial of its neuromuscular candidate, which had been planned for the first half of the year. The Boston biopharma’s stock dropped around 18% post-market Tuesday after the announcement.
The FDA put 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced February 2.
Entrada Therapeutics said it received a clinical hold notice from the regulatory agency but no reason was provided. “We are eager to resolve this hold and continue down the treatment development pathway,” President and CEO Dipal Doshi said.
Seattle-based Alpine Immune Sciences voluntarily terminated enrollment in two clinical trials of its immuno-oncology asset, davoceticept, after a second patient death. The company now plans to focus its attention on ALPN-303 for autoantibody-related inflammatory diseases.
