Tuesday turned out to be a nightmare for Nivalis Therapeutics Inc (NASDAQ:NVLS) investors, after the drug maker reported that its Phase 2 study of cavosonstat as an add-on to Orkambi in CF patients with F508del missed its primary endpoint. The trial demonstrated no benefits in lung function or sweat chloride, two established measures of activity.
Nivalis shares reacted to the news, crashing nearly 55% to $2.90 in early trading.
“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.
Summary of Key Data
The data announced today are from a Phase 2, double-blind, randomized, placebo-controlled, parallel-group trial that evaluated the efficacy and safety of two doses of cavosonstat administered twice daily (BID) in adult patients with CF who were homozygous for the F508del-CFTR mutation and being treated with Orkambi. The trial included a total of 138 adults who received treatment with cavosonstat (200 mg) with Orkambi (n=44), cavosonstat (400 mg) with Orkambi (n=48) and placebo with Orkambi (n=46) for 16 weeks. The trial included a 4-week withdrawal and follow-up period once patients had completed 12-weeks of dosing.
“We would like to express our sincere gratitude to everyone who participated in this trial, including the patients, their families, the trial investigators and our employees,” said Dave Rodman, chief medical officer and executive vice president of discovery at Nivalis. “Although we did not meet the primary endpoint, these data help inform the overall body of CF research, and we remain dedicated to completing our current clinical CF research program.” (Original Source)
On the ratings front, NVLS stock has been the subject of a number of recent research reports. In a report released today, Raymond James analyst Christopher Raymond and Cowen’s Phil Nadeau downgraded NVLS to Hold.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher Raymond and Phil Nadeau have a yearly average return of 35.7% and 1.8% respectively. Raymond has a success rate of 73% and is ranked #57 out of 4239 analysts, while Nadeau has a success rate of 48% and is ranked #1423.
Sentiment on the Street is neutral on NVLS stock. Out of 4 analysts who cover the stock, 4 suggest a Hold rating .
Nivalis Therapeutics, Inc. is a clinical stage pharmaceutical company which engages in discovery, development and commercialization of product for patients with cystic fibrosis. Its product includes N91115, a small molecule that addresses a defect in the cystic fibrosis transmembrane conductance regulator. The company was founded in 2008 and is headquartered in Boulder, CO.