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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.

News

Soleno Therapeutics Strengthens Leadership Team with Key Appointments

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Soleno Therapeutics, Inc. announced the appointments of key executives and advisors, including Meredith Manning as Chief Commercial Officer, Dairine Dempsey as Vice President, Europe, and Lauren Budesheim as Vice President of Human Resources. The company also appointed key advisors Shamim Ruff and James Geraghty. The new team brings extensive industry experience and expertise in global commercialization, regulatory affairs, and human resources. The appointments aim to strengthen capabilities in the U.S. and Europe as the company advances its DCCR therapy towards NDA and MAA filings for potential approval in Prader-Willi Syndrome.
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Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Soleno Therapeutics, Inc. (SLNO) announced the grant of inducement awards to three new employees, with 102,500 non-qualified stock options at an exercise price of $36.70 per share, vesting over a four-year period.
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Soleno Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Soleno Therapeutics, Inc. (NASDAQ: SLNO) announces the grant of inducement awards to two new employees. The Compensation Committee approved the grant of non-qualified stock options to purchase 145,000 shares of common stock at an exercise price of $21.93 per share. The options will vest over a four-year period, subject to continued employment.
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Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

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Soleno Therapeutics, Inc. reported positive statistically significant top-line data from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR for the treatment of Prader-Willi syndrome. Soleno's cash and cash equivalents were approximately $52.4 million as of September 30, 2023. They received gross proceeds of $169.9 million from recent financing activities.
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Soleno Therapeutics Announces Peer-Reviewed Publication of Results from Long-Term Open-Label Study of DCCR in Prader-Willi Syndrome

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Soleno Therapeutics, Inc. has published one-year results from the Phase 3 DESTINY PWS study and the open-label extension period of Study C602, evaluating DCCR tablets for patients with Prader-Willi syndrome (PWS). The study showed significant improvements in hyperphagia and other behavioral complications in participants. Soleno plans to submit an NDA to the FDA for DCCR in mid-2024.
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Correcting & Replacing -- Soleno Therapeutics Announces DCCR Data Presentation at the Foundation for Prader-Willi Research Symposium

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Soleno Therapeutics to present at FPWR Research Symposium
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Soleno Therapeutics Announces DCCR Data Presentation at the Foundation for Prader-Willi Research Symposium

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Soleno Therapeutics announces oral presentation at FPWR 2023 Research Symposium on results from Study C602 for the treatment of Prader-Willi syndrome.
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Soleno Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Concurrent Private Placement of Common Stock and Pre-Funded Warrants and Full Exercise of Underwriters’ Option to Purchase Additional Shares

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Soleno Therapeutics closes public offering, raising $69.0 million
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Soleno Therapeutics Announces Pricing of Approximately $120 Million Underwritten Public Offering of Common Stock and Concurrent Private Placement of Common Stock and/or Pre-Funded Warrants

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Soleno Therapeutics, Inc. announces pricing of underwritten public offering of 3,000,000 shares of common stock at $20.00 per share, expected to raise approximately $60.0 million. Underwriters granted 30-day option to purchase up to 450,000 additional shares. Concurrent private placement with existing investors for up to approximately $60.0 million. Closing expected on or about October 2, 2023.
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Soleno Therapeutics Announces Proposed Public Offering of Common Stock and/or Pre-Funded Warrants and a Concurrent Private Placement of Common Stock and/or Pre-Funded Warrants

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Soleno Therapeutics, Inc. plans to offer and sell shares of its common stock and/or pre-funded warrants in a public offering. The underwriters have an option to purchase additional shares equal to 15% of the offering. The company also intends to enter into a securities purchase agreement for up to $30 million of shares. Guggenheim Securities, Cantor Fitzgerald & Oppenheimer are acting as book-running managers. The offering is subject to market conditions.
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FAQ

What is the current stock price of Soleno Therapeutics (SLNO)?

The current stock price of Soleno Therapeutics (SLNO) is $45.18 as of December 20, 2024.

What is the market cap of Soleno Therapeutics (SLNO)?

The market cap of Soleno Therapeutics (SLNO) is approximately 1.9B.

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.

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Soleno Therapeutics, Inc.

Nasdaq:SLNO

SLNO Rankings

#1983 Ranked by Market Cap
N/A Ranked by Dividends

SLNO Stock Data

1.95B
39.11M
3.05%
100.97%
11%
Biotechnology
Electromedical & Electrotherapeutic Apparatus
Link
United States of America
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