Soleno Therapeutics, Inc. (SLNO - Free Report) announced that it has completed enrollment in the phase III study evaluating its lead candidate Diazoxide Choline Controlled-Release (DCCR) tablets for the treatment of patients with Prader-Willi Syndrome (PWS). The company recruited approximately 100 patients in the ongoing double-blind, placebo-controlled DESTINY PWS study, which is evaluating once-daily DCCR tablets versus placebo for the given patient population.
Soleno Therapeutics plans to announce top-line data from the above-mentioned study in the first half of 2020.
Shares of Soleno Therapeutics were up 6.9% following this news on Monday. In fact, the stock has soared 55.3% in the past year versus the industry’s decrease of 2.5%.
Per the company, as of Jan 3, more than 95% of patients who randomized in the DESTINY PWS study either completed or continued to be treated while under evaluation. Moreover, interested patients might continue with treatment in the open-label extension study C602 for up to two additional years. To date, no serious side effects have been reported in DESTINY PWS study.
We remind investors that in March 2019, the Data Safety Monitoring Board (DSMB) recommended the continuation of the DESTINY PWS study without modification, thus supporting the safety profile of DCCR tablets.
Subsequently, in October 2019, the DSMB for the second time recommended the continuation of the DESTINY PWS study without modification, backing the safety profile of DCCR tablets for the given indication.
Notably, in July 2018, the DCCR development program for treating PWS was granted a Fast Track designation by the FDA. DCCR already enjoys an orphan drug status for PWS in the United States and in the EU.
Zacks Rank & Stocks to Consider
Soleno Therapeutics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Pacira BioSciences, Inc. (PCRX - Free Report) , AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) and Corcept Therapeutics Incorporated (CORT - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Pacira’s earnings estimates have moved 2.9% north for 2020 over the past 60 days. The stock has rallied 11.3% in the past year.
AcelRx’s loss per share estimates have narrowed 7.5% for 2020 over the past 60 days.
Corcept’s earnings estimates have been revised 5.4% upward for 2020 over the past 60 days.
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