Soleno Therapeutics, Inc. (SLNO): History, Ownership, Mission, How It Works & Makes Money

Soleno Therapeutics, Inc. (SLNO): History, Ownership, Mission, How It Works & Makes Money

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Ever wondered about the companies dedicated to tackling rare diseases? Soleno Therapeutics, Inc. (SLNO), currently trading around $67.23 per share, stands out as a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics. With a recent FDA approval for VYKAT™ XR to treat hyperphagia in Prader-Willi Syndrome, how does Soleno plan to further impact the rare disease treatment landscape? Keep reading to explore Soleno's history, ownership, mission, operational mechanisms, and revenue generation strategies.

Soleno Therapeutics, Inc. (SLNO) History

Soleno Therapeutics, Inc. Founding Timeline

Year established

Soleno Therapeutics, Inc. was founded in 2008.

Original location

The company is headquartered in Redwood City, California.

Founding team members

Specific details about the founding team members are not readily available in the provided search results. Further research would be needed to accurately identify the individuals involved in the initial establishment of Soleno Therapeutics.

Initial capital/funding

Information regarding the initial capital or funding of Soleno Therapeutics during its founding in 2008 is not available within the provided search results. Additional dedicated research would be necessary to ascertain these specific financial details.

Soleno Therapeutics, Inc. Evolution Milestones

Year Key Event Significance
2010 Licensed exclusive worldwide rights to diazoxide choline controlled-release (DCCR) DCCR became Soleno's lead development candidate for Prader-Willi Syndrome (PWS).
2014 Completed Phase 1 clinical study of DCCR Demonstrated that DCCR was generally safe and well-tolerated.
2015 Began Phase 3 clinical development of DCCR (DESTINY PWS) Advanced DCCR into pivotal trials for the treatment of PWS.
2018 Announced positive topline results from DESTINY PWS study DCCR met the primary endpoint and showed statistically significant improvement in hyperphagia.
2020 Received a Refusal to File letter from the FDA for its NDA for DCCR The FDA determined that the NDA was not sufficiently complete to permit a substantive review.
2022 Completed a Type A meeting with the FDA to discuss the path forward for DCCR Alignment reached on additional data needed to support a resubmission of the NDA.
2023 Announced positive results from a study evaluating DCCR in patients with PWS who had previously participated in clinical trials Further supported the long-term safety and efficacy of DCCR.
2024 Submitted the New Drug Application (NDA) to the FDA for DCCR for the treatment of Prader-Willi Syndrome (PWS) Marked a significant step toward potential FDA approval and commercialization of DCCR.

Soleno Therapeutics, Inc. Transformative Moments

  • Licensing of Diazoxide Choline Controlled-Release (DCCR): This was a pivotal moment as DCCR became the company's leading drug candidate, specifically targeting Prader-Willi Syndrome (PWS).
  • Positive Phase 3 DESTINY PWS Study Results (2018): Achieving statistically significant improvements in hyperphagia, a key symptom of PWS, significantly validated their clinical development strategy.
  • FDA Refusal to File Letter (2020): This setback necessitated a strategic reassessment and further engagement with the FDA to determine the additional data required for NDA resubmission.
  • Type A Meeting with the FDA (2022): This meeting was crucial for charting a clear path forward, aligning with regulatory expectations for resubmitting the NDA for DCCR.
  • New Drug Application (NDA) Submission (2024): The submission of the NDA for DCCR marked a crucial milestone, representing years of research and development and paving the way for potential commercialization.

To gain further insights into the company's core values, refer to: Mission Statement, Vision, & Core Values of Soleno Therapeutics, Inc. (SLNO).

Soleno Therapeutics, Inc. (SLNO) Ownership Structure

Understanding Soleno Therapeutics, Inc.'s ownership structure is crucial for investors and stakeholders, providing insights into the company's control and governance. The company's shares are distributed among institutional investors, retail investors, and company insiders.

Soleno Therapeutics, Inc.'s Current Status

Soleno Therapeutics, Inc. is a publicly traded company, meaning its shares are available for purchase on the stock market. This allows a wide range of investors to own a portion of the company. For a deeper dive into the investor landscape, check out Exploring Soleno Therapeutics, Inc. (SLNO) Investor Profile: Who’s Buying and Why?

Soleno Therapeutics, Inc.'s Ownership Breakdown

The following table provides an overview of the ownership distribution of Soleno Therapeutics, Inc. as of the latest available data from the 2024 fiscal year:

Shareholder Type Ownership, % Notes
Institutional Investors 58.68% These are firms that invest on behalf of others, such as hedge funds, mutual funds, and pension funds.
Individual Insiders 1.94% This includes key executives and board members who hold shares in the company.
Retail Investors 39.38% These are individual investors who buy and sell securities for their own accounts.

Soleno Therapeutics, Inc.'s Leadership

The leadership team plays a vital role in guiding the strategic direction and operational execution of Soleno Therapeutics, Inc. Key members of the leadership team include:

  • Anish Bhatnagar, M.D.: Chief Executive Officer
  • Kristen K. Neese: Chief Financial Officer
  • Jennifer L. Chao: Board Member

Soleno Therapeutics, Inc. (SLNO) Mission and Values

Soleno Therapeutics is dedicated to developing and commercializing novel therapeutics for the treatment of rare diseases. The company values innovation, patient-centricity, and integrity in its pursuit of improving the lives of individuals with unmet medical needs.

Soleno Therapeutics' Core Purpose

Official mission statement

While Soleno Therapeutics does not have a single, explicitly stated mission statement readily available in its recent SEC filings or investor presentations, its core purpose can be inferred from its activities and goals. The company focuses on developing treatments for rare diseases, particularly those with unmet needs. This is evident in their work with DCCR for Prader-Willi Syndrome.

  • Developing and commercializing novel therapeutics.
  • Targeting rare diseases with unmet medical needs.
  • Improving the lives of patients, particularly those with Prader-Willi Syndrome (PWS).

Vision statement

Similarly, a specific vision statement is not formally declared. However, Soleno Therapeutics' vision can be understood as striving to become a leader in the development of treatments for rare diseases. This includes:

  • Leading the field in innovative therapies for rare diseases.
  • Expanding treatment options for conditions like Prader-Willi Syndrome.
  • Achieving significant advancements in patient care and quality of life.

Company slogan/tagline

Currently, there is no widely publicized or officially declared slogan or tagline for Soleno Therapeutics. The absence of a formal slogan does not diminish the company's focus on its objectives, which are communicated through its actions and product development efforts.

To gain more insights into Soleno Therapeutics, Inc., consider reading Exploring Soleno Therapeutics, Inc. (SLNO) Investor Profile: Who’s Buying and Why?

Soleno Therapeutics, Inc. (SLNO) How It Works

Soleno Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing novel therapeutics for the treatment of rare diseases. The company's primary focus is on Prader-Willi Syndrome (PWS).

Soleno Therapeutics, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
DCCR (Diazoxide Choline Controlled Release) Prader-Willi Syndrome (PWS) patients Once-daily oral tablet designed to address hyperphagia, a hallmark symptom of PWS.

Soleno Therapeutics, Inc.'s Operational Framework

Soleno Therapeutics operates with a focus on clinical development and regulatory approval of DCCR for Prader-Willi Syndrome. Key aspects of their operational framework include:

  • Clinical Trials: Conducting rigorous clinical trials to demonstrate the safety and efficacy of DCCR.
  • Regulatory Submissions: Preparing and submitting New Drug Applications (NDAs) to regulatory agencies like the FDA to gain approval for commercialization.
  • Manufacturing and Supply Chain: Establishing a reliable manufacturing process and supply chain to ensure consistent availability of DCCR if approved.
  • Commercialization Strategy: Developing a comprehensive commercialization strategy including marketing, sales, and distribution plans to reach the PWS patient population.

Soleno Therapeutics, Inc.'s Strategic Advantages

Soleno Therapeutics, Inc. aims to achieve market success through several strategic advantages:

  • Focus on Unmet Need: PWS is a rare genetic disorder with limited treatment options, representing a significant unmet medical need.
  • DCCR Potential: DCCR has shown promise in clinical trials to reduce hyperphagia, a key driver of morbidity and mortality in PWS patients.
  • Orphan Drug Designation: DCCR has been granted Orphan Drug Designation by the FDA, which provides certain benefits, including market exclusivity upon approval.

To gain more insights into the company's financial stability, consider reading this analysis: Breaking Down Soleno Therapeutics, Inc. (SLNO) Financial Health: Key Insights for Investors

Soleno Therapeutics, Inc. (SLNO) How It Makes Money

Soleno Therapeutics, Inc. is a late-stage biopharmaceutical company that historically has not generated revenue from product sales. The company focuses on developing and commercializing novel therapeutics for the treatment of rare diseases, with a primary emphasis on Prader-Willi Syndrome (PWS). As of April 2025, its potential revenue streams are tied to the successful development, regulatory approval, and subsequent commercialization of its lead product candidate, Diazoxide Choline Controlled-Release (DCCR) for PWS.

Soleno Therapeutics, Inc. Revenue Breakdown

As Soleno Therapeutics is in the clinical stage and does not have products on the market as of April 2025, a traditional revenue breakdown is not applicable. Instead, potential future revenue streams are outlined based on their lead product candidate.

Revenue Stream % of Total Growth Trend
DCCR Product Sales (Potential) 100% (If Approved) Potentially Increasing
Licensing and Partnerships (Potential) Varies Uncertain

Soleno Therapeutics, Inc. Business Economics

Soleno Therapeutics operates within the biopharmaceutical industry, which is characterized by high research and development costs, lengthy regulatory approval processes, and significant market exclusivity periods post-approval. The economic viability of Soleno hinges on several factors:

  • Clinical Trial Success: Positive outcomes from clinical trials are crucial for regulatory approval.
  • Regulatory Approval: Securing approval from regulatory bodies like the FDA in the United States and EMA in Europe is essential.
  • Market Access and Pricing: Successfully negotiating pricing and reimbursement agreements with healthcare providers and insurers will impact revenue.
  • Manufacturing and Distribution: Establishing efficient manufacturing and distribution networks to ensure product availability.
  • Intellectual Property: Maintaining strong patent protection to safeguard market exclusivity.

Given that Soleno focuses on rare diseases like Prader-Willi Syndrome, it may benefit from orphan drug designations, which provide incentives such as market exclusivity and tax credits.

Soleno Therapeutics, Inc. Financial Performance

As a development-stage pharmaceutical company, Soleno's financial performance is primarily evaluated based on its cash runway, operating expenses, and progress in clinical development. Key aspects of their financial performance include:

  • Cash Position: Monitoring cash reserves to fund ongoing clinical trials and operations.
  • R&D Expenses: Tracking research and development expenditures as they advance DCCR through clinical stages.
  • Operating Expenses: Managing administrative and other operational costs to maintain financial stability.
  • Net Loss: Expecting net losses as typical for companies in the development stage, with potential for future profitability upon successful commercialization.
  • Financing Activities: Assessing the need for additional funding through equity offerings, debt financing, or partnerships.

For detailed insights into Soleno Therapeutics, Inc. (SLNO) and its investors, explore: Exploring Soleno Therapeutics, Inc. (SLNO) Investor Profile: Who’s Buying and Why?

Soleno Therapeutics, Inc. (SLNO) Market Position & Future Outlook

Soleno Therapeutics is navigating a challenging market landscape with its primary focus on developing treatments for rare diseases. The company's future hinges significantly on the successful development and commercialization of its lead product candidate, Diazoxide Choline Controlled Release (DCCR) for Prader-Willi Syndrome (PWS).

Competitive Landscape

Company Market Share, % Key Advantage
Soleno Therapeutics Relatively Small (Specific % unavailable) Focus on DCCR for Prader-Willi Syndrome, a potentially disease-modifying treatment.
Zafgen (defunct) N/A Historically a competitor in obesity and PWS treatments, but no longer operational.
Rhythm Pharmaceuticals Growing (Specific % unavailable) Setmelanotide (IMCIVREE®) for obesity and genetic deficiencies leading to obesity.

Opportunities & Challenges

Opportunities Risks
Potential FDA approval and successful commercialization of DCCR for PWS, addressing a significant unmet medical need. Clinical trial setbacks or failure to meet regulatory approval standards for DCCR.
Expansion of DCCR's application to other rare diseases or related metabolic disorders. Competition from other companies developing therapies for PWS or related conditions.
Strategic partnerships or collaborations to expand market reach and accelerate development. Reliance on key personnel and potential loss of expertise.
Dependence on successful fundraising to support ongoing research and development activities. As of the fiscal year 2023, the company had a cash balance of $26.8 million, which is expected to fund operations into the third quarter of 2024. Additional financing will be required to further advance DCCR.

Industry Position

Soleno Therapeutics currently holds a niche position within the pharmaceutical industry, focusing on rare diseases. Its success is closely tied to the clinical and regulatory outcomes of DCCR. Here are some key points regarding their industry standing:

  • Focus on Rare Diseases: The company strategically targets rare diseases like Prader-Willi Syndrome, which often have limited treatment options, offering the potential for significant impact and market exclusivity.
  • Lead Product Candidate: DCCR represents Soleno's primary asset and a potential game-changer in PWS treatment, distinguishing it from competitors.
  • Financial Condition: Soleno’s financial stability is crucial. The company's ability to secure additional funding will significantly influence its capacity to advance DCCR through clinical trials and the regulatory process.

To gain more insight into the company's strategic vision, explore Mission Statement, Vision, & Core Values of Soleno Therapeutics, Inc. (SLNO).

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