Nivalis Therapeutics (NVLS):Notes From The Road, All Eyes On SNO6 - Stifel
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Stifel analyst, Thomas Schrader, reiterated his Buy rating on shares of Nivalis Therapeutics (NASDAQ: NVLS) after hosting a day of investor meetings with Nivalis’ management. The most important event on the horizon for the company remains the SNO6 trial testing cavosonstat (formerly N91115) in delF508 homozygous patients with data expected very late this year. In addition, the relevance of the SNO7 trial testing cavosonstat in Kalydeco-treated patients was also emphasized as the bar for success may be lower in these patients further up the CFTR function curve.
SNO6 is the key trial in the development of cavosonstat and data from this trial is expected around year end. The trial is powered about 80% to detect a 5% absolute improvement in FEV1 relative to placebo arm in either the 200 mg or 400 mg treatment arm (n=45 per arm). Within each treatment arm, patients will also be compared to their own pretreatment FEV1 levels and the trial is powered to see smaller changes within each group. At about the same time as this data, the company expects to have six-month rat and nine-month dog safety data, along with six month mouse carcinogenicity data, potentially making cavosonstat a true Phase III asset.
No change to the price target of $16.
Shares of Nivalis Therapeutics closed at $6.40 yesterday.
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