www.fdanews.com/articles/175478-nivalis-cystic-fibrosis-candidate-garners-fda-fast-track-status
Nivalis Cystic Fibrosis Candidate Garners FDA Fast Track Status
February 25, 2016
Nivalis Therapeutics has snapped up FDA fast track designation for its N91115, a stabilizer of the cystic fibrosis transmembrane conductance regulator protein.
Data is expected from the candidate’s Phase 2 trial in the second half of 2016. The treatment also recently won orphan drug status for cystic fibrosis.