FDA grants Nivalis cystic fibrosis drug Fast Track status

BOULDER — Nivalis Therapeutics Inc. (Nasdaq: NVLS) got another boost from the U.S. Food and Drug Administration this week as the company’s cystic fibrosis drug N91115 was granted Fast Track designation.

The FDA designation provides for accelerated review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs.

The Fast Track designation comes just a month after Nivalis landed Orphan Drug designation for N91115. That designation provides special status to drugs intended to treat, diagnose or prevent diseases that affect fewer than 200,000 people in the United States.

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N91115 is currently in the middle of a Phase 2 clinical trial, with results expected later this year.