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Rocket Pharmaceuticals (RCKT) stock gains as Needham upgrades the company to Buy after FDA alignment on a pivotal Phase 2 trial for a Danon disease.drug. Read more here.
Rocket Pharmaceuticals aligns with the FDA on key phase II study elements for RP-A501, advancing its Danon disease gene therapy program toward completion.
Needham said the FDA outcome was better than expected because the regulator could have demanded meaningful changes to Rocket’s Danon disease trial.
The FDA confirmed continued enrollment and dosing under the modified trial protocol after reviewing safety data from the first three patients treated at the recalibrated dose.
Rocket Pharmaceuticals announces positive early safety results for its RP-A501 Phase 2 trial in Danon disease and plans further FDA talks.
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