Rocket Pharmaceuticals Reaches FDA Alignment On Pivotal Phase 2 Trial Design For RP-A501 In Danon Disease
Portfolio Pulse from Benzinga Newsdesk
Rocket Pharmaceuticals has reached an agreement with the FDA on the design of a pivotal Phase 2 trial for RP-A501 in Danon Disease. The company anticipates filing the Clinical Trial Application (CTA)/Investigational Medicinal Product Dossier (IMPD) for RP-A501 in the third quarter of this year to initiate EU study activities. Rocket has also secured an ICD-10 code from CMS for LAMP2 deficiency in Danon Disease.
September 12, 2023 | 8:02 pm
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Rocket Pharmaceuticals' alignment with the FDA on the Phase 2 trial design for RP-A501 and the anticipated filing of the CTA/IMPD in Q3 could potentially boost investor confidence and positively impact the company's stock in the short term.
The alignment with the FDA on the Phase 2 trial design for RP-A501 is a significant regulatory milestone for Rocket Pharmaceuticals. This, along with the anticipated filing of the CTA/IMPD in Q3, indicates progress in the company's pipeline, which could boost investor confidence and positively impact the stock price in the short term.
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