Nivalis Therapeutics Priced, Nasdaq: NVLS

Developing a complementary small molecule therapy for cystic fibrosis.

Industry: Health Care

Latest Trade: $2.40 0.00 (0.0%)

First Day Return: +6.6%

Return from IPO: -82.9%

Industry: Health Care

We are a clinical stage pharmaceutical company committed to the discovery, development and commercialization of product candidates for patients with cystic fibrosis, or CF. CF is a life-shortening genetic disease that affects an estimated 70,000 people worldwide, including approximately 65,000 in the United States and Europe. Our lead product candidate, N91115, is a small molecule that addresses a defect in the cystic fibrosis transmembrane conductance regulator, or CFTR, resulting from mutations in the CFTR gene, the underlying cause of CF. We believe N91115 is a first-in-class CFTR stabilizer that modulates CFTR activity through GSNOR inhibition, which is a novel mechanism that we expect to be complementary to existing and future CFTR modulators. We own exclusive rights to N91115 in the United States and all other major markets, including U.S. composition of matter patent protection until at least 2031. Currently, we are conducting a Phase 1b clinical trial in CF patients homozygous for the F508del CFTR mutation, the most prevalent CFTR mutation. Following this, we intend to initiate a Phase 2 clinical trial that will assess the safety and efficacy of N91115 in a triple therapy with two other CFTR modulators, lumacaftor together with ivacaftor, or lumacaftor/ivacaftor. We plan to initiate the Phase 2 clinical trial as soon as feasible after the commercial launch of lumacaftor/ivacaftor, which has a PDUFA date of July 5, 2015. We expect to report top line results from our Phase 2 clinical trial six to nine months after initiation.
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IPO News for Nivalis Therapeutics
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IPO Data
IPO File Date 05/13/2015
Offer Price $14.00
Price Range $13.00 - $15.00
Offer Shares (mm) 5.5
Deal Size ($mm) $77
IPO Data
IPO Date 06/16/2015
Offer Price $14.00
Price Range $13.00 - $15.00
Offer Shares (mm) 5.5
Deal Size ($mm) $77
Underwriters
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Company Data
Headquarters Boulder, CO
Founded 2007
Employees 23
Website www.nivalis.com