We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Nivalis (NVLS) Reports Wider-than-Expected Loss in Q2
Read MoreHide Full Article
Nivalis Therapeutics, Inc. reported a second-quarter 2016 loss of 55 cents per share, wider than the Zacks Consensus Estimate of a loss of 52 cents. The reported loss was, however, narrower than the year-ago loss of $1.41 per share.
With no approved product in Nivalis’ portfolio at the moment, the company does not generate revenues yet.
In the second quarter of 2016, research and development expenses were $6.4 million, up almost 44% from the year-ago quarter. General and administrative were $2.2 million, up 56.6% from the year-ago quarter.
Cavosonstat in Focus
Nivalis has made significant progress with its lead candidate, cavosonstat (N91115).
In Jul 2016, the company announced the completion of enrollment in the phase II study evaluating cavosonstat for the treatment of patients with cystic fibrosis (CF), who have two copies of the F508del mutation, when added to Vertex Pharmaceuticals Inc.’s (VRTX - Free Report) Orkambi.
The double-blind, randomized, placebo-controlled, parallel group, 16-week (including a 4-week follow-up) study, which has enrolled 138 patients, is being conducted to evaluate the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg twice daily, compared to placebo when added to Orkambi. Top-line data should be out by the end of this year.
In May 2016, Nivalis dosed the first patient in a second phase II study on cavosonstat. This proof-of-concept study is being conducted to evaluate the efficacy and safety of cavosonstat (400 mg twice daily) as add-on therapy to Vertex’s Kalydeco in adults who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein.
The study will randomize approximately 20 CF patients to either cavosonstat with Kalydeco or placebo with Kalydeco. Data from the study is expected in the first half of 2017.
We are encouraged by the company’s progress with cavosonstat. Investor focus should remain on updates pertaining to its development.
Nivalis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Nivalis (NVLS) Reports Wider-than-Expected Loss in Q2
Nivalis Therapeutics, Inc. reported a second-quarter 2016 loss of 55 cents per share, wider than the Zacks Consensus Estimate of a loss of 52 cents. The reported loss was, however, narrower than the year-ago loss of $1.41 per share.
With no approved product in Nivalis’ portfolio at the moment, the company does not generate revenues yet.
In the second quarter of 2016, research and development expenses were $6.4 million, up almost 44% from the year-ago quarter. General and administrative were $2.2 million, up 56.6% from the year-ago quarter.
Cavosonstat in Focus
Nivalis has made significant progress with its lead candidate, cavosonstat (N91115).
In Jul 2016, the company announced the completion of enrollment in the phase II study evaluating cavosonstat for the treatment of patients with cystic fibrosis (CF), who have two copies of the F508del mutation, when added to Vertex Pharmaceuticals Inc.’s (VRTX - Free Report) Orkambi.
The double-blind, randomized, placebo-controlled, parallel group, 16-week (including a 4-week follow-up) study, which has enrolled 138 patients, is being conducted to evaluate the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg twice daily, compared to placebo when added to Orkambi. Top-line data should be out by the end of this year.
In May 2016, Nivalis dosed the first patient in a second phase II study on cavosonstat. This proof-of-concept study is being conducted to evaluate the efficacy and safety of cavosonstat (400 mg twice daily) as add-on therapy to Vertex’s Kalydeco in adults who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein.
The study will randomize approximately 20 CF patients to either cavosonstat with Kalydeco or placebo with Kalydeco. Data from the study is expected in the first half of 2017.
We are encouraged by the company’s progress with cavosonstat. Investor focus should remain on updates pertaining to its development.
Nivalis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
NIVALIS THERAPT Price
NIVALIS THERAPT Price | NIVALIS THERAPT Quote
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>