Rocket Pharma falls as it encounters delay on Kresladi

Shares of US gene therapy company Rocket Pharmaceuticals (Nasdaq: RCKT) dipped as much as 5% to $26.99, after it announced the US Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; formerly RP-L201) for severe leukocyte adhesion deficiency-I (LAD-I).

Rocket explained that the FDA extended the review period by three months, to June 30, 2024, to allow additional time to review clarifying Chemistry, Manufacturing, and Controls (CMC) information submitted by Rocket in response to FDA information requests. The FDA has further confirmed that an advisory committee meeting is not needed.

“We look forward to continuing our close collaboration with the FDA and together share a deep sense of responsibility in the rigorous process required to bring novel, potentially curative gene therapies, like Kresladi to patients who need them most,” said Dr Gaurav Shah, chief executive of Rocket Pharma, adding: “We remain confident and focused on making this therapy available for patients as quickly as possible.”