Moderna, Inc. (MRNA) announced the FDA has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia due to methylmalonic-CoA mutase deficiency. mRNA-3705 is being investigated in a Phase 1/2 study, the company said.
The START pilot program was initiated by the FDA in September 2023 to accelerate the development of treatments addressing unmet medical needs in rare diseases, with an initial selection of up to seven novel treatments.
Kyle Holen, Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology, said: "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."
Shares of Moderna are up 3% in pre-market trade on Thursday.
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