The European Medicines Agency has granted PRIME status to Rocket Pharmaceuticals’ (RCKT +9.9%) gene therapy RP-L102 for the treatment of a rare bone marrow failure called Fanconi anemia.
PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.
A Phase 2 study is in process.
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