Regenex Bio eyes FDA meeting to confirm pivotal DMD trial [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
The US-based biotech is looking to investigate its gene therapy candidate RGX-202 in a Phase III trial in DMD patients. The update comes just one day after Pfizer paused dosing in its DMD programme following the fatality of a young boy from the Phase II DAYLIGHT study. Regenex Bio's end of Phase II meeting with the FDA is due to take place in early Q3 2024 with hopes to initiate the pivotal trial by the end of Q3 or early Q4 2024. The Phase II dose level two from the Affinity Duchenne trial (NCT05693142) has been selected as the pivotal dose to use in Phase III. Regenex Bio CEO Kenneth Mills said: "We expect to make significant progress across our prioritised pipeline, including advancing our Duchenne programme into a pivotal stage. Regardless of today's landscape of Duchenne treatments, communication from the FDA continues to support the need for alternative gene therapies for rare diseases, including Duchenne.” Regenex has also announced data from the second patient from th
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