MRNA - FDA Selects Moderna's Rare Disease Candidate For Accelerated Development Program | Benzinga
Thursday, the FDA selected Moderna Inc’s (NASDAQ:MRNA) mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program.
mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency.
“Selection for this program will enable enhanced communication with the U.S. FDA, resulting in acceleration of our development program as we prepare for pivotal study initiation for mRNA-3705 in 2024,” said Kyle Holen, Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.
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