Results

Nivalis shares in meltdown as cystic fibrosis promise withers in PhII flop

Jon Congleton, Nivalis

Jon Congleton, Nivalis

Eighteen months ago, little Nivalis Therapeutics managed to catch the tail winds of a long-running biotech IPO market and ride it to a $77 million windfall on an early-stage promise that it could do some real good for cystic fibrosis patients. But late Monday, the Boulder, CO-based company was forced to concede that its mid-stage work on its lead drug had failed, leaving that $14 IPO price a bitter memory for investors who watched the share price tank, falling 53% to $2.94.

Nivalis sold its IPO $NVLS on the chance its lead drug, a CFTR stabilizer, could amp up the efficacy of a Vertex combo treatment. But the data didn’t back that up, with the drug failing against the primary endpoint of FEV1 as well as sweat chloride reduction.

Investigators recruited 138 patients for the study, testing the drug on patients who were already being treated with Vertex’s Orkambi, which combines Kalydeco and lumacaftor.

Company execs, though, promised to carry on, somehow.

“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,” said Jon Congleton, president and chief executive officer of Nivalis.


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RAPS Regulatory Convergence 2017