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Soleno Therapeutics, Inc. - SLNO STOCK NEWS

Welcome to our dedicated page for Soleno Therapeutics news (Ticker: SLNO), a resource for investors and traders seeking the latest updates and insights on Soleno Therapeutics stock.

Soleno Therapeutics, Inc. (symbol: SLNO) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics for the treatment of rare diseases. The company's lead candidate, DCCR (Diazoxide Choline Controlled-Release) Tablets, is a once-daily oral medication currently in its Phase 3 clinical development program for Prader-Willi Syndrome (PWS). PWS is a rare genetic disorder characterized by chronic hunger, leading to severe obesity, among other complications.

Soleno Therapeutics has achieved significant milestones, including the FDA's Breakthrough Therapy Designation for DCCR, indicating promising preliminary data. This designation aims to expedite the development and review process of DCCR, reflecting the drug's potential to offer substantial improvements over existing therapies.

Financially, Soleno is well-positioned, with cash and cash equivalents amounting to approximately $169.7 million as of December 31, 2023, bolstered by a successful public offering and warrant exercises. The company continues to invest significantly in research and development, with expenses reaching $25.2 million for the year ended December 31, 2023, primarily driven by clinical trial costs and manufacturing efforts in preparation for NDA submission.

Soleno's strategic partnerships and acquisitions, including the 2016 merger with Essentialis, have enhanced its pipeline and development capabilities. The company is obligated to pay up to $21.2 million to former Essentialis stockholders upon achieving specific commercial milestones for DCCR sales.

The clinical data supporting DCCR is robust, with extensive research from five Phase 1 studies in healthy volunteers and three Phase 2 studies, including one focused on PWS patients. The data suggests DCCR's potential in addressing hyperphagia, aggressive behaviors, and other metabolic parameters associated with PWS.

With a strengthened leadership team and a clear focus on advancing DCCR through regulatory processes, Soleno Therapeutics aims to provide a new treatment option for PWS patients. For the latest updates and more detailed information, visit the company's official website at www.soleno.life.

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Soleno Therapeutics has submitted a New Drug Application (NDA) to the U.S. FDA for its drug DCCR (diazoxide choline) extended-release tablets, aimed at treating Prader-Willi syndrome (PWS) in individuals aged four and older suffering from hyperphagia.

This submission is a pivotal step for Soleno, offering a potential new therapeutic solution for PWS, a rare condition characterized by life-threatening overeating and other severe symptoms.

DCCR has received Breakthrough, Fast Track, and Orphan Drug designations in the U.S., as well as Orphan Drug designation in the E.U. The FDA will decide on the NDA's acceptance within 60 days, and Soleno has requested Priority Review, which could shorten the review period to six months.

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Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare diseases, announced the grant of inducement awards to eight new employees, as required by Nasdaq rules. The Board of Directors approved the issuance of non-qualified stock options for 247,200 shares at an exercise price of $41.15 per share, which matches the closing price on June 21, 2024. These options vest over four years, with 25% vesting after one year and the remaining shares vesting monthly. This grant falls under Soleno's 2020 Inducement Equity Incentive Plan.

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Soleno Therapeutics (NASDAQ: SLNO) announced its inclusion in the Russell 3000® Index, effective July 1, 2024, following the Russell US Indexes annual reconstitution.

This inclusion reflects Soleno's progress with its lead candidate, DCCR (diazoxide choline) extended-release tablets, currently in clinical development for the treatment of rare diseases.

Membership in the Russell 3000® Index includes automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index and relevant growth and value style indexes.

Russell indexes are essential for investment managers and institutional investors, with $10.5 trillion in assets benchmarked against them as of December 2023.

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Soleno Therapeutics announced that data from the randomized withdrawal period of Study C602, focusing on DCCR (diazoxide choline) extended-release tablets in Prader-Willi Syndrome (PWS), will be presented at ENDO 2024. The presentation will occur on June 2, 2024, at the Annual Meeting of the Endocrine Society in Boston.

The study's results indicate that withdrawing DCCR worsens hyperphagia (excessive hunger) and increases weight and BMI in patients with PWS. The presentation, titled 'Withdrawal of DCCR (Diazoxide Choline) Extended-Release Tablets Worsens Hyperphagia and Increases Weight and BMI in a 16-week Double-blind, Placebo-controlled, Randomized Withdrawal Period in Patients with Prader Willi Syndrome,' will be delivered by Dr. Evelien Gevers from Barts Health NHS Trust and Queen Mary University London.

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Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, announced CEO Anish Bhatnagar will participate in two upcoming investor conferences. The Jefferies Global Healthcare Conference is set for June 5, 2024, at 11:30 AM ET, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, at 4:00 PM ET. Live audio webcasts and replays will be available on the company's website.

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On May 15, 2024, Soleno Therapeutics launched an initiative in honor of Prader-Willi Syndrome (PWS) Awareness Day. PWS is a genetic disease affecting one in 15,000 births globally, characterized by symptoms like hypotonia, hyperphagia, and intellectual disability. The campaign features a Times Square billboard showcasing nearly 100 individuals from the PWS community. A new website, www.Support4PWS.com, aims to boost awareness and support. CEO Dr. Anish Bhatnagar emphasized the company's commitment to the PWS community. The initiative aligns with May being PWS Awareness Month and National PWS Awareness Day on May 15.

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Soleno Therapeutics provided a corporate update and reported its first-quarter financial results for 2024. The company closed a public offering, received Breakthrough Therapy Designation from the FDA for Diazoxide Choline Extended-Release for Prader-Willi syndrome, planned an NDA submission for mid-2024, published a peer-reviewed paper, and expanded its leadership team. Financially, Soleno had significant cash reserves, with increased research and development expenses, higher general and administrative expenses, and obligations for future commercial milestones. The net loss for the quarter was $21.4 million.

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Soleno Therapeutics, Inc. announced a public offering of 3,000,000 shares of common stock at $46.00 per share, expected to yield approximately $138.0 million in gross proceeds. The company granted the underwriters a 30-day option to purchase up to 450,000 additional shares. The offering is set to close around May 7, 2024, with plans to utilize the proceeds for research and development of DCCR tablets for Prader-Willi Syndrome treatment, and general corporate purposes.

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Soleno Therapeutics, a clinical-stage biopharmaceutical company, announced a proposed public offering of common stock. The company intends to offer shares to fund research and development efforts, including advancing DCCR tablets for the treatment of Prader-Willi Syndrome. The offering is subject to market conditions, with the net proceeds to be used for various corporate purposes.

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Soleno Therapeutics announced the publication of a comparison study showing significant improvements in hyperphagia and PWS-related behaviors with DCCR treatment for Prader-Willi syndrome. The study demonstrated positive results from the Phase 3 trials, indicating the potential of DCCR to enhance the quality of life for PWS patients.

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FAQ

What is Soleno Therapeutics' primary focus?

Soleno Therapeutics is focused on developing and commercializing novel therapeutics for treating rare diseases, with a primary focus on Prader-Willi Syndrome (PWS).

What is DCCR?

DCCR (Diazoxide Choline Controlled-Release) is a once-daily oral tablet developed by Soleno Therapeutics for the treatment of Prader-Willi Syndrome (PWS).

What recent milestones has Soleno Therapeutics achieved?

Soleno has received Breakthrough Therapy Designation from the FDA for DCCR and raised substantial funds through public offerings to support its development efforts.

What is Prader-Willi Syndrome (PWS)?

PWS is a rare genetic disorder characterized by chronic hunger, leading to severe obesity, cognitive disabilities, and behavioral problems.

What is the current financial status of Soleno Therapeutics?

As of December 31, 2023, Soleno Therapeutics had approximately $169.7 million in cash and cash equivalents, with ongoing investments in research and development.

What significant data supports the development of DCCR?

DCCR's development is supported by data from five Phase 1 studies and three Phase 2 studies, including significant improvements in symptoms of PWS patients.

What are Soleno's obligations to former Essentialis stockholders?

Soleno is obligated to make cash payments up to $21.2 million upon achieving certain commercial milestones associated with DCCR sales.

What partnerships has Soleno Therapeutics formed?

Soleno has formed strategic partnerships, including the 2016 merger with Essentialis, enhancing its pipeline and development capabilities.

What are the next steps for Soleno Therapeutics?

Soleno is preparing for a New Drug Application (NDA) submission for DCCR in mid-2024 and working on commercial launch preparations.

Where can I find more information about Soleno Therapeutics?

For more detailed information, visit Soleno Therapeutics' official website at www.soleno.life.

Soleno Therapeutics, Inc.

Nasdaq:SLNO

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1.73B
36.41M
1.53%
101.32%
9.11%
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