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Rocket Pharmaceuticals (NASDAQ: RCKT) shares rose 4% on Wednesday after the biotechnology company secured access to up to $150 million under a credit facility with Hercules Capital.
Under the terms of the agreement, Rocket drew an initial $35m upon closing.
Rocket Pharmaceuticals (NASDAQ:RCKT) outlined updated clinical, regulatory and commercial plans for its investigational gene therapy RP-A501 in Danon disease, reporting longer-term Phase I findings, preliminary Phase II observations and an FDA-aligned pivotal…
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) said September 15 that the FDA agreed to count three patients treated under the modified RP-A501 protocol toward the pivotal Phase 2 efficacy cohort of 12 male patients.
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.
Rocket Pharmaceuticals (NASDAQ:RCKT) shares rose 8% on Tuesday after the company said it reached alignment with the US Food and Drug Administration on the pivotal Phase 2 trial of RP-A501 for Danon disease.
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.