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Soleno Therapeutics, Inc. (SLNO)

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2.4100-0.1200 (-4.74%)
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Previous Close2.5300
Open2.5500
Bid2.3400 x 1000
Ask2.4700 x 800
Day's Range2.4100 - 2.5900
52 Week Range1.3000 - 4.3900
Volume201,369
Avg. Volume314,825
Market Cap191.874M
Beta (5Y Monthly)0.55
PE Ratio (TTM)N/A
EPS (TTM)-0.6870
Earnings DateMar 02, 2021 - Mar 08, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est8.67
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  • Benzinga

    Soleno Therapeutics, Vanderbilt University In Research Pact For K(ATP) Channel Activators

    Soleno Therapeutics Inc (NASDAQ: SLNO) has signed a collaboration agreement with Vanderbilt University for the discovery and development of KATP channel activators with the potential to treat rare diseases. The terms of the collaboration were not disclosed. Soleno's product candidate, DCCR, is a potent activator of KATP channels. Phase 3 data in Prader-Willi Syndrome subjects showed the study did not meet its primary endpoint of change from baseline in hyperphagia (abnormally strong sensation of hunger). But significant positive changes in two of three secondary endpoints were observed. ATP-dependent potassium (or KATP) channels are present in several tissues in the body. Activating these channels is beneficial in the treatment of various rare diseases, such as hyperinsulinemic hypoglycemia. This collaboration aims to develop in vivo and in vitro tools to identify and characterize novel KATP channel activators from recently identified new classes of chemistry. Soleno expects to advance appropriate candidates generated from this collaboration into human trials. Price Action: SLNO shares are down 5.56% at $2.72 on the last check Tuesday. See more from BenzingaClick here for options trades from BenzingaMeridian Bioscience Pulls Out Revogene COVID-19 Test EUA ApplicationOcugen's Vision Loss Gene Therapy Receives Orphan Drug Tag In Europe© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome
    GlobeNewswire

    Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome

    Recent analysis of Phase 3 DESTINY PWS limited to data collected before the onset of the COVID-19 pandemic shows statistical significance in the primary and key secondary endpointsREDWOOD CITY, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today hosted a Key Opinion Leader (KOL) webinar and provided an update on the Company’s ongoing Phase 3 program evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). “PWS is estimated to impact about 10,000 – 20,000 people in the U.S., and is characterized by hyperphagia, an insatiable feeling of hunger, and various other behavioral and metabolic abnormalities that severely impact the daily lives of patients and their families,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Given the considerable impact of the COVID-19 pandemic, particularly for individuals with PWS and their families as highlighted during our webinar, it was critical for us to evaluate the data from our Phase 3 DCCR trial that was generated prior to the significant disruptions caused by the pandemic.” “Our analysis of the data through March 1, 2020 found statistically significant differences between DCCR and placebo patients for the primary and all key secondary endpoints. We continue to be encouraged by these data and positive changes experienced by our subjects with DCCR treatment. We look forward to continuing our interactions with the regulatory authorities,” concluded Dr. Bhatnagar. In an analysis of study results with data through March 1, 2020, a date shortly before a national emergency was declared due to COVID-19, the primary endpoint demonstrated a statistically significant change from baseline in hyperphagia for DCCR compared to placebo. The change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0-36). An improvement in HQ-CT is represented by a decrease in the score. Key secondary endpoints, as well as several additional subjective endpoints measuring improvement in behavior and communication, that were not significant in the top-line analyses, were also all significant in the analysis of data through March 1, 2020. No significant differences in safety were noted compared to the top-line analysis. Analysis of Primary Endpoint Top-line analysis June 2020Data through March 1, 2020 DCCR (N=82)Placebo (N=42)DCCR (N=80)Placebo (N=41)Change from Baseline in Hyperphagia-5.94 (0.88)-4.27 (1.15)-6.64 (1.00)-3.51 (1.28)LS Mean Difference [DCCR-Placebo]-1.67-3.13p-value0.1980.037 Key Secondary Endpoints Top-line analysis June 2020p-valueData through March 1, 2020p-valueClinical Global Impression of Improvement (CGI-I) at Visit 70.030.015Change from Baseline in Body Fat Mass (DXA) at Visit 7 0.030.004Caregiver Global Impression of Change (Caregiver GI-C) at Visit 7 0.410.031 In addition to the pre-COVID-19 data presented by Soleno at the webinar, Theresa Strong, Ph.D., co-founder and Director of Research Programs at the Foundation for Prader-Willi Research, provided an overview of the impact of the COVID-19 pandemic on more than 300 PWS patients and their families. Results from the Global PWS Registry’s “Impact of COVID” Survey emphasized that PWS patients and their caregivers have experienced significant disruptions due to the COVID-19 pandemic. A significant proportion of caregivers (85%) reported more stress. For patients, lack of social activity, remote learning and the loss of in-person therapy have had a substantial negative impact, with the loss of routine and structure contributing to increased challenges in food control and behavioral management. Jennifer Miller, M.D., Director of the University of Florida Health Prader-Willi Syndrome Program and a Professor in the Division of Pediatric Endocrinology at the UF Department of Pediatrics, provided a summary of PWS and the obstacles faced by PWS patients and their families. Dr. Miller also reviewed the current treatment landscape and unmet need in PWS, as well as the positive biochemical, physical, and behavioral changes observed to date with DCCR treatment in her patients. A replay of the event is available in the Investors section on the Company’s website at www.soleno.life. About Diazoxide Choline Controlled-Release (DCCR) TabletDiazoxide Choline Controlled-Release tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in PWS patients. In the PWS Phase 2 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and abnormal lipid profiles. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, Diazoxide Choline Controlled-Release (DCCR) tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase III clinical development program. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding results of clinical trials, the timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578

  • GlobeNewswire

    Soleno Therapeutics to Host Key Opinion Leader Meeting on DCCR for the Treatment of Prader-Willi Syndrome

    Webinar on Thursday, February 4, at 12:00 PM ETREDWOOD CITY, Calif., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced it will host a Key Opinion Leader (KOL) webinar and provide a corporate update on Thursday, February 4, 2021, at 12:00 PM Eastern Time, featuring presentations by Dr. Jennifer Miller, from the University of Florida, and Dr. Theresa Strong, from the Foundation for Prader-Willi Research. Dr. Miller will discuss the current treatment landscape and unmet medical need for patients with Prader-Willi Syndrome (PWS), and data from Soleno's once-daily Diazoxide Choline Controlled Release (DCCR) tablet. Dr. Strong will review the impact of the COVID-19 pandemic on PWS families. Soleno's management team will also provide an update from Soleno’s ongoing Phase III DCCR program. Jennifer Miller, M.D., is the Director of the University of Florida (UF) Health Prader-Willi Syndrome Program and a Professor in the Division of Pediatric Endocrinology at the UF Department of Pediatrics. She graduated with her medical degree from UF in 1998 and her master’s degree in clinical investigation from UF in 2005. Dr. Miller has done all of her training in pediatrics and pediatric endocrinology at UF. As Director of the PWS program at UF, she follows one of the largest cohorts of PWS patients in the world. Theresa Strong, Ph.D., is a co-founder and the Director of Research Programs at the Foundation for Prader-Willi Research, a patient group that supports research to advance the understanding and treatment of PWS. Dr. Strong received her B.S. from Rutgers University and a Ph.D. in Medical Genetics from the University of Alabama at Birmingham (UAB). Prior to joining FPWR full time, she was a faculty member at UAB, working in the area of cancer gene therapy. To participate in the webinar, please register here. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, Diazoxide Choline Controlled-Release (DCCR) tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase III clinical development program. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578