In a stunner, FDA immediately drops its hold on Juno’s lead CAR-T
So much for bureaucracy. In what may well be the shortest high-profile FDA clinical hold in the agency’s history, Juno reported today that the FDA has lifted the halt on its lead CAR-T program, satisfied that it found the cause for three patient deaths.
Juno’s battered shares $JUNO immediately rocketed back up 28%.
Juno confounded investors last week when it reported the deaths and the surprising hold, citing the recent addition of the chemotherapy agent fludarabine to its preconditioning of patients as a likely culprit. Some experts, who had used the drug in other studies to help clear the path for a followup therapy, publicly questioned the rationale. But the agency had no problem providing a quick green light to resume the pivotal study.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.