Rocket Pharmaceuticals Announced The FDA Has Extended The Priority Review Period For Kresladi Application For Severe Leukocyte Adhesion Deficiency-I, By Three Months To June 30, 2024
Portfolio Pulse from Benzinga Newsdesk
The FDA has extended the priority review period for Rocket Pharmaceuticals' Kresladi application for severe Leukocyte Adhesion Deficiency-I by three months to June 30, 2024. This extension is to allow additional time for the review of clarifying Chemistry, Manufacturing, and Controls (CMC) information submitted by Rocket in response to FDA requests. The FDA also confirmed that an advisory committee meeting is not needed.
February 13, 2024 | 12:27 pm
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NEUTRAL IMPACT
The FDA's extension of the priority review period for Rocket Pharmaceuticals' Kresladi application may delay the potential market entry but confirms ongoing regulatory progress without the need for an advisory committee meeting.
The extension of the review period indicates a delay in the potential approval and market entry of Kresladi, which could be perceived negatively by investors. However, the absence of a need for an advisory committee meeting and the specific reason for the extension (additional review of CMC information) suggest that there are no major concerns about the application itself. This mixed impact is likely to result in a neutral short-term price direction.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90