ReGenX Biosciences submitted data to the FDA in response to a request for longer-term pivotal results for its gene therapy.
2 reports, 1 independent
Updated Aug 19
Gone quiet
- Reports
- 2
- Developments
- 1
- Repetition
- 50%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
ReGenX Biosciences submitted data to the FDA in response to a request for longer-term pivotal results for its gene therapy.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
-
ReGenX Biosciences (United States)
company in Washington D.C., United States
Nothing else this week.
Related events
- The FDA requested additional clinical data from Unicycive Therapeutics.
- Anavex Life Sciences submitted data for FDA discussions and received scientific advice from the EMA.
- Data was presented in Athens supporting a future U.S. NDA submission to the FDA.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.
- A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.
Coverage
Newest first; wire copies grouped- PR NewswireREGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly ad
- PR NewswireREGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy Con