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Nivalis (NVLS) Cystic Fibrosis Study Misses Primary Endpoint


Nivalis Therapeutics, Inc.’s NVLS shares plunged almost 53% in after-hours trading on Nov 28 after the company announced disappointing top-line data from a phase II study on its lead candidate, cavosonstat, for the treatment of cystic fibrosis (CF).

The double-blinded, randomized, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg, administered twice daily, in adults with CF who had two copies of the F508del-CFTR mutation and were being treated with Vertex Pharmaceuticals Inc.’s VRTX Orkambi.

Data showed that the study failed to meet the primary endpoint of demonstrating a benefit in the absolute change in percent-predicted FEV1 (lung function) or in sweat chloride reduction at 12 weeks, in comparison to placebo. However, there was no dose-limiting toxicity and cavosonstat was found to be well tolerated across all the doses in the study.


Nivalis intends to continue evaluating the potential of cavosonstat with these data and its S-nitrosoglutathione reductase inhibitor portfolio, which it will develop for the treatment of other diseases, to decide on the next step forward. The company plans to remain focused on the completion of the CF research program.

We note that earlier this month, Nivalis announced the completion of enrollment in a second phase II study on cavosonstat. The study will 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. Top-line data is anticipated in the first quarter of 2017.

Cavosonstat was granted Orphan Drug and Fast Track status for the treatment of CF by the FDA earlier this year.

However, considering that cavosonstat is the lead candidate in the company’s pipeline, the latest phase II study results are far from encouraging.

Zacks Rank & Key Picks

Nivalis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. SCMP and Vanda Pharmaceuticals, Inc. VNDA. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged approximately 84% year to date.

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