The FDA has slapped a clinical hold on Rocket Pharmaceuticals’ pivotal gene therapy trial in response to a death. Rocket, which was aiming to report data in mid-2026, dropped its targeted trial completion date and outlined actions to extend its cash runway after suffering the setback.

The U.S. FDA has paused Rocket Pharmaceuticals' mid-stage gene therapy trial after a patient died from serious complications, the drug developer said on Tuesday, sending its shares tumbling as much as 63.

Key Takeaways Rocket Pharmaceuticals halted a study of a gene-therapy drug for Danon disease because a patient had a "Serious Adverse Event" and later died.The patient suffered from complications related to a blood vessel leak.