Neurocrine to Acquire Soleno Therapeutics, Expanding Its Endocrinology and Rare Disease Portfolio
VYKAT™ XR (diazoxide choline) is the First and Only FDA Approved Treatment for Hyperphagia in Prader-Willi Syndrome and Represents a Transformative Therapy
Expands Neurocrine's High-Growth Commercial Portfolio to Three First-in-Class Medicines Including INGREZZA® (valbenazine) and CRENESSITY® (crinecerfont)
Establishes a Durable Platform for Long-Term Revenue Growth and Value Creation, Supported by Strong VYKAT XR Intellectual Property Estate Expected to Extend into the mid-2040s
Neurocrine to Host Conference Call at
The acquisition of Soleno and the addition of VYKAT™ XR (diazoxide choline), a first-in-class therapy to treat hyperphagia, the defining feature of Prader-Willi syndrome (PWS), will expand Neurocrine's portfolio of innovative medicines and strengthen its leadership position in endocrinology and rare disease. Since its FDA approval and successful
"This transaction will advance Neurocrine's mission to deliver life-changing treatments while accelerating our revenue growth and portfolio diversification strategy. We share the Soleno team's deep commitment to the Prader-Willi syndrome community and look forward to leveraging our experience and capabilities to expand VYKAT XR's reach to benefit more patients, while further strengthening Neurocrine's leadership in delivering transformative medicines," said
"Neurocrine is the right strategic partner to expand the reach of VYKAT XR in the Prader-Willi syndrome community given their experience in endocrinology and rare disease and their proven ability to execute successful commercial launches. We are excited to accelerate VYKAT XR's impact for PWS patients following completion of the transaction by leveraging Neurocrine's strong commercial capabilities," said
PWS is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15 that affects about 10,000 patients in
Strategic Rationale and Financial Benefits of the Transaction
The transaction is expected to:
- Strengthen Neurocrine's Leadership in Endocrinology and Rare Disease, and Advance a Diversified Portfolio of First-in-Class Medicines: Following the completion of the transaction, Neurocrine will have three marketed, first-in-class therapies: INGREZZA®, the vesicular monoamine transmitter 2 (VMAT2) market leader for the treatment of tardive dyskinesia and the chorea associated with Huntington's disease, with
$2.51 billion in 2025 revenue; CRENESSITY®, approved inDecember 2024 for the treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, with$301 million in 2025 revenue; and VYKAT XR, approved inMarch 2025 for the treatment of PWS, with$190 million in 2025 revenue for Soleno. Together, these medicines will position Neurocrine to deliver sustained revenue growth through the end of this decade. - Add a First-in-Class Therapy with Durable Value Creation: VYKAT XR is the first and only FDA‑approved therapy for hyperphagia with PWS in
the United States . Following a successful launch in 2025, VYKAT XR is well positioned as the foundational first-line therapy for PWS and is supported by a strong intellectual property estate that is expected to extend into the mid-2040s, providing a durable platform for long‑term value creation. - Provide a Transformative Therapy Aligned with Neurocrine's Strategic Focus. PWS is a neurodevelopmental disorder, and VYKAT XR aligns well with Neurocrine's capabilities addressing diseases at the intersection of neuroscience and endocrinology. Alongside CRENESSITY and an emerging endocrinology portfolio, VYKAT XR will serve as a strong foundation to further build Neurocrine's leadership over time.
- Enhance Ability to Deliver Long-Term Shareholder Value: Upon closing, the acquisition of Soleno is expected to contribute to a more diversified and durable revenue base, expand Neurocrine's commercial reach, immediately enhance Neurocrine's growth profile, and increase scale to support sustained innovation and development. This is further supported by continued pipeline progress and disciplined capital allocation. Integration of Soleno's operations is expected to drive cost synergies and operational efficiencies as Neurocrine leverages its existing infrastructure.
Transaction Terms and Financing
Under the terms of the merger agreement, Neurocrine, through a subsidiary, will commence a cash tender offer to acquire all of the outstanding shares of Soleno's common stock at a price of
The boards of directors of both companies have approved the transaction, which is expected to close within 90 days of this announcement, subject to satisfaction of customary closing conditions, including receipt of regulatory approvals.
Neurocrine to Host Conference Call Today
Neurocrine will hold a live conference call and webcast today at
Advisors
Goldman Sachs & Co. LLC is serving as exclusive financial advisor and Cooley LLP is serving as legal advisor to Neurocrine. Centerview Partners LLC and Guggenheim Securities, LLC are serving as financial advisors and Wilson Sonsini Goodrich & Rosati, Professional Corporation is serving as legal counsel to Soleno.
About INGREZZA® (valbenazine)
Please see additional safety information, full Prescribing Information, including Boxed Warning, and Medication Guide.
About CRENESSITY® (crinecerfont)
Please see additional safety information and full Prescribing Information.
About Neurocrine Biosciences
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc.
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food-seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.
INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
IMPORTANT SAFETY INFORMATION
Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.
Warnings and Precautions
Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.
Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.
Please see the full Prescribing Information, including Medication Guide.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. Soleno's first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.
Forward-Looking Statements
This communication contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of each of Soleno and Neurocrine, including statements relating to the ability to complete and the timing of completion of the transactions contemplated by the Agreement and Plan of Merger, dated as of
Additional Information about the Acquisition and Where to Find It
The tender offer for all of the outstanding shares of Soleno described in this communication has not yet commenced. This communication is for informational purposes only, is not a recommendation and is neither an offer to purchase nor a solicitation of an offer to sell any securities, nor is it a substitute for the tender offer materials that Neurocrine and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. A solicitation and offer to purchase outstanding shares of Soleno will only be made pursuant to an offer to purchase and related tender offer materials that Neurocrine and its acquisition subsidiary intend to file with the SEC. At the time that the tender offer is commenced, Neurocrine and its acquisition subsidiary will file a tender offer statement on Schedule TO, and Soleno will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF SOLENO ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AND EACH AS IT MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF SOLENO SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal) will be made available at no expense on Neurocrine's website at neurocrine.com/investors and (once they become available) will be mailed to the stockholders of Soleno free of charge. The Solicitation/Recommendation Statement and other documents filed with the SEC by Soleno will be available at no expense at Soleno's website at investors.soleno.life. The information contained in, or that can be accessed through, Neurocrine's and Soleno's respective websites are not a part of, or incorporated by reference herein. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal), as well as the Solicitation/Recommendation Statement, will also be made available for free on the SEC's website at www.sec.gov. Copies of those offer documents and all other documents filed by Neurocrine and Soleno will be made available at no charge by directing a request to the information agent for the tender offer, which will be named in the Schedule TO. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Neurocrine and Soleno each file annual, quarterly, and current reports, proxy statements and other information with the SEC. You may read any reports, statements or other information filed by Neurocrine or Soleno with the SEC for free on the SEC's website at www.sec.gov.
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SOURCE Neurocrine Biosciences, Inc.
