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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.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease treatments, has announced inducement grants to six new employees as required by Nasdaq Stock Market rules. The company's independent board members approved non-qualified stock options to purchase 143,850 shares of common stock. These options have exercise prices of $49.52 and $48.44 per share, matching Soleno's closing stock prices on August 13 and 16, 2024, respectively.
The option awards will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent on continued employment. These grants fall under Soleno's 2020 Inducement Equity Incentive Plan and are designed to attract and retain talent in compliance with Nasdaq Listing Rule 5635(c)(4).
Soleno Therapeutics (NASDAQ: SLNO) announced changes to its Board of Directors. Dawn Carter Bir, a seasoned biotech executive with over 30 years of industry experience, has been appointed to the Board. Ernest Mario, Ph.D. is stepping down as Chair due to health reasons, and Matthew Pauls, J.D., M.B.A. is assuming the role of Lead Independent Director.
Ms. Bir's extensive experience in commercialization, strategic business development, and global operational leadership is expected to be valuable as Soleno prepares for a potential launch of DCCR. She recently served as Executive VP and Chief Commercial Officer at Reata Pharmaceuticals, contributing to the company's first product approval and launch, leading to a $7.3B acquisition by Biogen in 2023.
Soleno Therapeutics (NASDAQ: SLNO) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Submission of a New Drug Application (NDA) to the FDA for DCCR to treat Prader-Willi Syndrome (PWS).
2. Closing of a $158.7 million public offering.
3. Granted Breakthrough Therapy Designation for DCCR by the FDA.
4. Presentation of Study C602 data at ENDO 2024.
5. Inclusion in the Russell 3000® Index.
Financial results show $294.6 million in cash and equivalents as of June 30, 2024. R&D expenses increased to $12.3 million for Q2 2024, up from $5.1 million in Q2 2023. G&A expenses rose to $10.9 million from $3.2 million year-over-year. Net loss for Q2 2024 was $21.9 million or $0.57 per share.
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.
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.
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.
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.
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.
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.
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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