Cystic Fibrosis Drug Maker Nivalis Therapeutics Has $77M IPO

Xconomy Boulder/Denver — 

Nivalis Therapeutics, a Boulder, CO-based drug company developing a treatment for cystic fibrosis, made its debut on the Nasdaq on Wednesday with a $77 million public offering.

Formerly N30 Pharmaceuticals, Nivalis (NASDAQ: NVLS) sold 5.5 million shares, more than it had previously planned, at $14 each. Shares opened the day at $16.50 and climbed to $17.84 within the first hour of trading before dropping to $15.03 at 1 p.m. MT. That gives Nivalis a market capitalization around $219 million.

Nivalis is pinning its hopes on a drug candidate named N91115 that would be used to treat cystic fibrosis. The drug is in Phase 1b clinical trials to test safety and tolerability in CF patients.

Nivalis believes the drug could be used in combination with two drugs developed by Vertex Pharmaceuticals (NASDAQ: VRTX), ivacaftor (Kalydeco) and Orkambi, which itself is a combination of ivacaftor and lumacaftor. Those drugs, like N91115, work by treating underlying genetic abnormalities present in certain CF patients.

If its Phase 1B trial succeeds, Nivalis’s next step would be to test the safety and efficacy of the three drugs together. Nivalis believes N91115 would improve the efficacy of Vertex’s combination therapy by stabilizing a critical protein it binds to. Orkambi prevents the protein from being misfolded and allows it to move to the surface of cells.

Ivacaftor was approved by the FDA in 2012 and already is on the market, and in May an FDA panel recommended final approval for the lumacaftor/ivacaftor combination. Final approval is expected to come by July 5. Nivalis does not have any commercialization or cooperation agreements with Vertex.

Nivalis’s underwriters have a 30-day option to purchase up to an additional 825,000 shares of common stock at the initial public offering price.