Nivalis Therapeutics shares tumble on negative trial results

BOULDER – Nivalis Therapeutics Inc.’s stock lost more than half of its value Tuesday after the company reported negative trial results for its cystic fibrosis drug, covosonstat.

After markets closed Monday, Boulder-based Nivalis (Nasdaq: NVLS) announced that a Phase 2 clinical trial looking at the use of cavosonstat in adult patients who also were being treated with Orkambi failed to meet its primary endpoint. Cavosonstat is the company’s lead drug candidate.

Markets reacted swiftly to the news. The company’s shares were trading at $2.56 apiece near the end of Tuesday’s trading day, down $3.69 from Monday’s close of $6.25.

Nivalis officials said there were no dose-limiting toxicities in the trial, and that cavosonstat was well-tolerated at all doses.

“While we are disappointed in the outcome of this trial, we plan to continue to investigate the therapeutic potential of cavosonstat and our S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to determine next steps,” Nivalis’ president and chief executive Jon Congleton said in a news release.

Momentum had seemed to be building for cavosonstat. Earlier this year, Nivalis had been awarded Fast Track designation for the drug from the U.S. Food and Drug Administration, a designation that provides for accelerated review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs. That came one month after the drug landed Orphan Drug designation, which provides special status to drugs intended to treat, diagnose or prevent diseases that affect fewer than 200,000 people in the United States.

Nivalis raised a $30 million round of private equity funding in 2014 before raising $88.55 million in an initial public offering in June of last year.


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