Crinecerfont

Total Second-Quarter 2026 Revenue Grew 39% Year-Over-Year to $959 Million INGREZZA® (valbenazine) 2026 Net Sales Guidance Raised to $2.825 to $2.875 Billion Acquisition of Soleno Therapeutics Completed in May 2026 SAN DIEGO, July 30, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2026. "Our second quarter performance demonstrates the power of a strategy designed to compound over time," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "As our commercial portfolio of first-in-class medicines continues to grow, so does our capacity to reinvest in innovation, advance a differentiated late-stage pipeline and pursue strategic opportunities that strengthen the company for the long term. With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an enduring company poised to deliver meaningful value for patients and shareholders for years to come." Total Revenue Highlights Total revenues for the second quarter 2026 were $959 million, compared with $688 million in the prior-year period representing 39% year-over-year growth. Unaudited pro-forma total revenues were $998 million for the second quarter 2026 when including full quarter VYKAT XR net product sales. INGREZZA second-quarter 2026 net product sales were $716 million, representing 15% growth year-over-year. Results reflected double-digit prescription volume growth in TRx and record NRx driven by strong patient demand. INGREZZA full year 2026 guidance was increased from a range of $2.7 billion to $2.8 billion up to $2.825 billion to $2.875 billion. CRENESSITY second-quarter 2026 net product sales were $184 million, driven by strong patient demand with approximately 80% reimbursement for dispensed prescriptions in the second quarter 2026. VYKAT XR second-quarter 2026 net product sales were $54 million from May 18, 2026, the closing date of the Soleno acquisition. Unaudited pro-forma full quarter net product sales were $94 million. Recent Clinical and Corporate Developments In May 2026, acquired Soleno Therapeutics for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion. The addition of VYKAT XR, a first-in-class therapy to treat hyperphagia in Prader-Willi syndrome (PWS), expands Neurocrine's portfolio of innovative medicines and strengthens its leadership position in endocrinology and rare disease. In May 2026, the Company entered into a $1.0 billion senior secured revolving credit facility to provide an additional source of liquidity for general corporate purposes. As of June 30, 2026, available borrowing capacity was $1.0 billion. Announced new two-year data from the Phase 3 CAHtalyst® Pediatric study showing positive growth outcomes in children and adolescents with classic congenital adrenal hyperplasia treated with CRENESSITY. Announced new two-year data from the Phase 3 CAHtalyst® Adult study demonstrating improved cardiometabolic outcomes alongside sustained glucocorticoid dose reduction through up to two years of treatment with CRENESSITY for classic congenital adrenal hyperplasia. Announced publication of expert recommendations for glucocorticoid dose reduction after initiating CRENESSITY for the treatment of classic congenital adrenal hyperplasia. Presented new VYKAT XR data demonstrating meaningful and durable improvements in hyperphagia and behavioral symptoms in Prader-Willi syndrome following randomized withdrawal period. Announced new post-hoc data from the KINECT® 4 clinical trial demonstrating that adults with tardive dyskinesia treated with INGREZZA capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. Initiated Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia. Promoted Samir Siddhanti to the executive management team as Chief Business Officer where he will lead the Company's business development, corporate strategy, and R&D portfolio management functions helping guide Neurocrine's continued evolution into a leading, global biotechnology company. Second-Quarter 2026 Financial Results Second-quarter 2026 GAAP net income and earnings per share were $144 million and $1.39, respectively, compared with $108 million and $1.06, respectively, for second-quarter 2025. Second-quarter 2026 Non-GAAP net income and earnings per share were $297 million and $2.85, respectively, compared with $166 million and $1.65, respectively, for second-quarter 2025. A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 at the end of this press release. Second-quarter 2026 GAAP and Non-GAAP net income compared with second-quarter 2025 were primarily driven by: Higher net product sales of $272 million. For the second quarter 2026, GAAP operating expenses included certain expenses associated with the acquisition of Soleno Therapeutics, Inc., which closed in May 2026, and are excluded from Non-GAAP operating expenses. Increased R&D expense in support of an expanded and advancing pre-clinical and clinical portfolio included investments in the osavampator Phase 3 program in major depressive disorder (MDD) and the muscarinic franchise, including the direclidine Phase 3 program as a potential treatment for adults with schizophrenia. Development milestone expense included in R&D was $0.3 million and $15 million for the second quarter 2026 and 2025. Increased SG&A expense primarily reflected continued investment in our commercial organization, included the expansion of our INGREZZA and CRENESSITY sales teams in the first quarter of 2026 and partial quarter of expense for support of VYKAT XR. At June 30, 2026, the Company had cash, cash equivalents, and marketable securities totaling approximately $482 million. Full Year 2026 Financial Guidance INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. R&D guidance reflects the continued advancement of the Company's pre-clinical and clinical portfolio including the Phase 3 programs for osavampator in MDD and direclidine in schizophrenia, and includes approximately $25 million of expense for development milestones related to our in-licensed product candidates. Development milestones are included in R&D guidance once achieved or deemed probable to achieve. Non-GAAP guidance has been adjusted to exclude estimated non-cash stock-based compensation expense of approximately $115 million in R&D and $170 million in SG&A, including approximately $58 million related to the acceleration of vesting of equity awards for Soleno employees which vested in full upon the closing of the transaction, and acquisition, integration and divestiture-related expenses of approximately $95 million. Non-cash stock-based compensation expense for performance-based equity awards is included in guidance once the predefined performance-based criteria for vesting is achieved or deemed probable to achieve. IPR&D guidance represents completed collaboration and licensing arrangements. SG&A guidance reflects expense for ongoing commercial initiatives, including the recent expansion of our sales teams in Q1 2026, supporting INGREZZA growth and the launch of CRENESSITY and VYKAT XR. In connection with the acquisition of Soleno, the Company recorded approximately $2.2 billion of intellectual property related to VYKAT XR to the balance sheet, which will be amortized over an expected life of 16 years. Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 800-347-6865 (US) or 203-518-9757 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 4:30 p.m. Eastern Time on Neurocrine Biosciences' website under Investors at . A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. 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, hyperphagia in Prader-Willi syndrome, 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 more than 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. VYKAT is a registered trademark of Soleno Therapeutics, Inc. Non-GAAP Financial Measures In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains the following Non-GAAP financial measures: Non-GAAP cost of revenues, Non-GAAP R&D expense, Non-GAAP SG&A expense, Non-GAAP other income (expense), net, Non-GAAP net income and earnings per share. When preparing the Non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, these Non-GAAP financial measures exclude: non-cash stock-based compensation expense, amortization expense related to acquired intangible assets, amortization expense related to acquisition-date inventory fair value step-up, stock based compensation expense related to the acceleration of vesting of equity awards for Soleno employees, changes in fair value of equity investments, acquisition-related transaction and integration costs, gains on sales of businesses, net of transaction costs, other divestiture-related transaction costs, changes in foreign currency exchange rates and certain adjustments to income tax expense. These Non-GAAP financial measures are provided as a complement to results provided in accordance with GAAP as management believes these Non-GAAP financial measures are useful to investors because they help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these Non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined R&D and SG&A expenses on both a GAAP and a Non-GAAP basis. A reconciliation of these GAAP financial results to Non-GAAP financial results is included in the attached financial information. In connection with the Soleno acquisition, this press release also includes unaudited pro forma full quarter VYKAT XR net product sales and total revenue, Non-GAAP financial measures, which management uses, and believes is useful to investors, to provide supplemental information regarding VYKAT XR net product sales for the full second quarter of 2026, including the period from April 1, 2026 through May 17, 2026, prior to the closing of the acquisition on May 18, 2026. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully commercializing CRENESSITY and VYKAT XR; our financial and operating performance, including our future revenues, expenses, or profits; our full year 2026 financial guidance; our acquisition of Soleno Therapeutics, including the prospective benefits of the acquisition, and our strategy, plans, objectives, expectations (financial or otherwise) and intentions with respect to our future financial results, growth potential and anticipated product portfolio in connection with the acquisition; our collaborative partnerships; clinical and scientific data updates for our products and product candidates, including observations regarding clinical outcomes, safety, and tolerability; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general; risks and uncertainties associated with the commercialization of our products; risks related to our ability to realize the anticipated benefits of the acquisition of Soleno Therapeutics, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period and that we will not be able to integrate Soleno Therapeutics' business successfully or that such integration may be more difficult, time-consuming or costly than expected, disruption from the acquisition, making it more difficult to conduct business as usual or maintain relationships with employees, customers, suppliers, other business partners or governmental entities, unknown or inestimable liabilities, the risk of litigation and/or regulatory actions related to the acquisition, and the degree and pace of market uptake of VYKAT XR; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. SOURCE Neurocrine Biosciences, Inc. 21% more press release views with Request a Demo

July 1, 2026 -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH). Crinecerfont, marketed as CRENESSITY®, is approved in the United States as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients 4 years of age and older with classic CAH. "Infants and young children with classic CAH face significant health challenges and are often exposed to high doses of glucocorticoids during critical periods of growth and development," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "The initiation of this Phase 2 study reflects our commitment to evaluating crinecerfont as a potential treatment option that could reduce the need for long-term supraphysiologic glucocorticoid use and help mitigate the associated risks in this vulnerable, very young population." CAH is typically identified at or shortly after birth and can lead to life-threatening adrenal crises due to the underlying adrenal insufficiency, as well as androgen excess and consistent dosing of supraphysiologic glucocorticoids – complications for which there are no approved therapies in children under 4 years of age. Neurocrine is conducting this pediatric study under an FDA Pediatric Written Request. The Phase 2 open-label, single-arm study consists of a 24-week treatment period with a primary objective of assessing the safety and tolerability of crinecerfont in 20 participants aged 3 months to under 4 years with classic CAH. Secondary objectives include evaluation of the pharmacokinetics and pharmacodynamic effects of crinecerfont on hormone biomarkers. This study is expected to support a planned supplemental New Drug Application to expand the approved U.S. indication to include patients less than 4 years of age. Additional information about the trial, including eligibility criteria, can be found at ClinicalTrials.gov. Separately, Neurocrine achieved target enrollment for a Phase 2 study in the European Union to evaluate the safety and tolerability of crinecerfont in children from birth to under 2 years of age with classic CAH. Crinecerfont was approved by the U.S. Food and Drug Administration in 2024, marking the first therapeutic advancement in more than 70 years for patients with classic CAH. It is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces elevated adrenocorticotropic hormone (ACTH) secretion at the source and the resulting downstream excess adrenal androgens through a non-GC mechanism. Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens. Severe enzyme deficiency leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are typically still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in adrenal crisis and even death. Exogenous glucocorticoids (GCs) are necessary to correct the endogenous cortisol deficiency, but historically, doses higher than those needed for cortisol replacement (supraphysiologic) have been used to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at supraphysiologic doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with supraphysiologic GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to cardiometabolic and fertility issues in both sexes. The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs). CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces and controls excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients 4 to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. 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, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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. The content above comes from the network. if any infringement, please contact us to modify.