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Eloxx Pharmaceuticals Gets FDA Fast Track Designation for ELX-02 in Cystic Fibrosis

Eloxx Pharmaceuticals Inc. Thursday said the U.S. Food and Drug Administration gave fast track designation for ELX-02.

ELX-02 is a drug candidate intended to treat cystic fibrosis patients with nonsense mutations. ELX-02 is currently in Phase 2 clinical trials in CF patients affected by nonsense mutations in the CF transmembrane conductance regulator gene for whom there are no effective disease modifying therapies.

Structure of ELX-02. | Download Scientific Diagram

Shares were up 6% to $1.47 in premarket trading.

FDA grants fast track designation to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. Sponsors of drugs that receive fast track designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.

Sep 9, 2021

https://www.morningstar.com/

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