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# FDA Fast Track for Moderna mRNA Drug
- URL: https://www.fdaweb.com/fda-fast-track-for-moderna-mrna-drug/
- Published: 2019-10-23T12:00:00.000Z
- Updated: 2026-09-15T01:58:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145321

FDA has granted Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia. The company [announced an open IND](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestors.modernatx.com%2Fnews-releases%2Fnews-release-details%2Fmoderna-announces-open-ind-propionic-acidemia-program-mrna-3927&esheet=52115913&newsitemid=20191022006101&lan=en-US&anchor=announced+the+open+IND&index=1&md5=5722cea49971b195566a08fc474f0bb9&ref=fdaweb.com) for mRNA-3927 on 9/30\. Moderna says it is preparing to initiate a Phase 1/2 clinical study to evaluate the therapy’s potential to restore enzyme activity in patients with propionic acidemia.

Propioic acidemia is caused by the body’s inability to break down certain proteins and fats which leads to the build-up of toxic chemicals, according to the company. The disease is characterized by life-threatening illnesses in response to minor stressors, neurological dysfunction and cardiomyopathy, it says.