Soleno Therapeutics

Soleno Therapeutics, Inc. engages in the development and commercialization of novel therapeutics for the treatment of rare diseases. The firm focuses on the treatment of metabolic and neurobehavioral disorder. It offers its lead candidate, Diazoxide Choline Controlled-Release (DCCR), an oral tablet for the treatment of Prader-Willi Syndrome (PWS). The company was founded on August 25, 1999 and is headquartered in Redwood City, CA.

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Soleno Therapeutics, Inc. operates as clinical-stage biopharmaceutical company, which engages in the development and commercialization of novel therapeutics for the treatment of rare diseases. It focuses on the treatment of metabolic and neurobehavioral disorder. It offers its lead candidate, Diazoxide Choline Controlled-Release (DCCR), an oral tablet for the treatment of Prader-Willi Syndrome (PWS). The company was founded on August 25, 1999 and is headquartered in Redwood City, CA.

Soleno Therapeutics' DCCR shows promising results in reducing hyperphagia in PWS patients. I believe its FDA approval is likely by December 27, 2024. DCCR could become the first approved treatment for PWS hyperphagia, addressing a significant unmet medical need. DCCR's unique mechanism targets PWS hyperphagia while preserving lean mass. This potentially extends its use beyond PWS to weight loss, enhancing SLNO's market prospects.

Soleno Therapeutics Nears FDA Decision: Strong Buy Targeting PWS Hyperphagia Treatments

Soleno stock gains as the FDA says no advisory committee meeting is required for the DCCR NDA at present to treat hyperphagia associated with PWS.

SLNO Stock Rises on Upbeat Regulatory Update on PWS Drug NDA

If you are looking for stocks that are well positioned to maintain their recent uptrend, Soleno Therapeutics (SLNO) could be a great choice. It is one of the several stocks that passed through our "Recent Price Strength" screen.

Recent Price Trend in Soleno Therapeutics (SLNO) is Your Friend, Here's Why

Soleno Therapeutics (SLNO, Financial) experienced a notable stock price increase of 9.11% following positive developments in its regulatory process. This performance far exceeded that of the S&P 500 index, which saw gains of less than 1%.

SLNO Stock Rises as Prader-Willi Treatment Nears FDA Approval

The company's Prader-Willi treatment inched closer to FDA approval.

Why Soleno Therapeutics Stock Blasted 9% Higher Today

Janus Henderson Group

On September 30, 2024, Janus Henderson Group PLC, a prominent investment firm, significantly increased its stake in Soleno Therapeutics Inc (SLNO, Financial) by acquiring an additional 804,805 shares. This transaction, executed at a price of $50.49 per share, has raised the firm's total holdings in Soleno to 4,163,678 shares.

Janus Henderson Group PLC's Strategic Acquisition in Soleno Therapeutics Inc

REDWOOD CITY, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that management will present at the 2024 Cantor Global Healthcare Conference on Tuesday, September 17, 2024, at 8:00 AM Eastern Time.

Soleno Therapeutics to Present at 2024 Cantor Global Healthcare Conference

SLNO stock gains 6.3% as FDA accepts regulatory filing for lead candidate, DCCR, to treat hyperphagia associated with PWS under Priority Review.

Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review

Soleno Therapeutics, Inc.'s NDA submission of DCCR for the treatment of patients with PWS accepted by the FDA with Priority Review with a PDUFA date of December 27th of 2024. Before the FDA PDUFA date of DCCR for the treatment of patients with PWS, the FDA plans to hold an advisory panel meeting for this drug. If DCCR is granted U.S. marketing approval, it would be the first approved drug of its kind to target hyperphagia and some other problems associated with PWS.

Soleno Therapeutics: 2 New Catalysts To Bring Forth Change For PWS Patients

PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.

Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome

REDWOOD CITY, Calif., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced, as required by Nasdaq Stock Market rules, the grant of inducement awards to six new employees.

Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

REDWOOD CITY, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.

Soleno Therapeutics Announces Submission of New Drug Application to the U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets for the Treatment of Prader-Willi Syndrome

PHILADELPHIA, PA / ACCESSWIRE / June 11, 2024 / Kaskela Law LLC announces that it is investigating Soleno Therapeutics, Inc. (NASDAQ:SLNO) ("Soleno") on behalf of the company's stockholders. The investigation seeks to determine whether Soleno and/or the company's officers and directors violated the securities laws or breached their fiduciary duties to the company's investors in connection with recent corporate actions.

SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of Soleno Therapeutics, Inc. (NASDAQ: SLNO) and Encourages Long-Term Investors to Contact the Firm

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REDWOOD CITY, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that data from the randomized withdrawal period of Study C602 of DCCR (diazoxide choline) extended-release tablets in Prader-Willi Syndrome (PWS) will be featured in an oral presentation at the Annual Meeting of the Endocrine Society (ENDO 2024), being held June 1-4, 2024 in Boston, Massachusetts.

Soleno Therapeutics Announces Oral Presentation featuring DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome at ENDO 2024

REDWOOD CITY, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Anish Bhatnagar, M.D., Chief Executive Officer, will participate in the following upcoming investor conferences:

Soleno Therapeutics to Participate in Upcoming Investor Conferences

This Prader-Willi Syndrome Awareness Day, May 15, join Soleno Therapeutics in sharing messages of hope and kindness for the Prader-Willi syndrome community This Prader-Willi Syndrome Awareness Day, May 15, join Soleno Therapeutics in sharing messages of hope and kindness for the Prader-Willi syndrome community

Soleno Therapeutics Stands with the Prader-Willi Syndrome Community

REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the first quarter ended March 31, 2024.

Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq: SLNO), (“Soleno” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today the pricing of the underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $46.00 per share. The gross proceeds of the public offering are expected to be approximately $138.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Soleno has also granted the underwriters a 30-day option to purchase up to 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The public offering is expected to close on or about May 7, 2024, subject to market conditions and the satisfaction of customary closing conditions.

Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock

REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Nasdaq:SLNO), ("Soleno" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Soleno intends to grant the underwriters a 30-day option to purchase an additional number of shares of common stock equal to 15% of the aggregate number of shares of its common stock sold in the public offering. The public offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Soleno Therapeutics Announces Proposed Public Offering of Common Stock

Statistically Significant Improvements with DCCR Compared to Natural History of PWS from the PATH for PWS Study in Hyperphagia and PWS-related Behaviors Statistically Significant Improvements with DCCR Compared to Natural History of PWS from the PATH for PWS Study in Hyperphagia and PWS-related Behaviors

Soleno Therapeutics Announces Peer-Reviewed Publication of Data Comparing DCCR Treatment to the Natural History of Prader-Willi Syndrome

Soleno Therapeutics, Inc.'s New Drug Application filing of DCCR for the treatment of patients with Prader-Willi Syndrome expected by mid-2024. Ability to file NDA of DCCR for PWS was because of statistical significance achieved based on the primary endpoint of Study C602, which was the HQ-CT score. The global Prader-Willi Syndrome market in 2018 was estimated to be $2.11 billion in 2018.

Soleno: Mid-2024 NDA Filing For PWS Treatment Is A Major Catalyst To Watch

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for diazoxide choline. This designation is important to Soleno because it will help expedite the review process for its lead candidate.

Why Soleno Therapeutics Stock Is Skyrocketing Today

First Ever Breakthrough Designation for a Drug Being Developed for PWS Designation is Based on Data from the Phase 3 Program for DCCR Planned Submission of a New Drug Application (NDA) for DCCR  Remains on Track for Mid-2024 REDWOOD CITY, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia.

Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS)

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023.

News for Soleno Therapeutics Stock (SLNO)