SLNO stock is moving higher in early trading on January 10, 2020, after Craig-Hallum initiated coverage of the stock with a Buy rating.
Craig-Hallum analyst Frank Brisebois initiated coverage of Soleno Therapeutics with a Buy rating and $8 price target. The analyst tells investors in a research note that while he understands the inherent risk of a single product company with Phase 3 data expected in 1H20, he believes today’s market cap of $127M looks attractive when considering that annual revenue from Diazoxide Choline Controlled Release tablets alone could potentially exceed $500M by 2025. As the overall population studied in their pilot study showed statistically significant reductions in truly disruptive hyperphagia as well as consistent trends across relevant categories, he views Phase 3 as relatively de-risked.
On January 6, 2020, Soleno Therapeutics, Inc. (NASDAQ: SLNO, the Company or Soleno), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced that it has completed its target enrollment of approximately 100 subjects in the ongoing Phase III trial, DESTINY PWS, evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS). Additional patients who are currently scheduled to be screened for DESTINY PWS will be enrolled over the next few weeks.
“The achievement of target enrollment represents an important milestone for our DESTINY PWS clinical program,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. “We remain on track to announce top-line data in the first half of 2020. Moreover, we continue to be encouraged by the significant interest shown by families and investigators in keeping patients on DCCR. On behalf of everyone at Soleno, I would like to extend my gratitude to all of the patients, families and investigators involved in this study, as well as the Foundation for Prader-Willi Research (FPWR) and Prader-Willi Syndrome Association (PWSA) USA and UK for their support of DESTINY PWS.”
As of January 3, 2020, more than 95% of the patients randomized into DESTINY PWS have either completed or continue to be treated on study. More than 95% of patients enrolled in the C602 open-label extension study remain on treatment. Enrollment of patients was from 27 sites in the U.S. and the UK. No serious, unexpected adverse events related to DCCR have occurred in DESTINY PWS to date.
Based on the interest of the clinical investigators and families, Soleno will continue to make DCCR available to patients enrolled in the current program. The Company has, therefore, extended the C602 open-label extension study, allowing interested patients and families to continue in the study for up to two additional years.
DESTINY PWS is a randomized, double-blind, placebo-controlled study of once-daily oral administration of DCCR versus placebo in approximately 100 patients with a confirmed diagnosis of PWS. Patients who complete DESTINY PWS have the option to enroll into the C602 open-label extension study.
The U.S. Food and Drug Administration has designated the investigation of DCCR for the treatment of PWS to be a Fast Track development program. DCCR has also received orphan designation for the treatment of PWS in the U.S. and in the EU.
On December 23, 2019, Laidlaw analyst Yale Jen resumed coverage of Soleno Therapeutics with a Buy rating.
Also on December 23, 2019, Oppenheimer analyst Leland Gershell initiated coverage of Soleno Therapeutics with an Outperform rating and $10 price target. The company’s DCCR has demonstrated clinical proof-of-concept in Prader-Willi syndrome, and its active ingredient has a long record of human safety, Gershell tells investors in a research note. With “just” a ~$65M enterprise value, the analyst likes the stock’s the risk/reward and recommends building a position ahead of the Phase 3 reveal in the first half of 2020.