Neurocrine Biosciences (NBIX -0.41%) generated $959 million in revenue in Q2 2026, representing an increase of 39% year over year. Its flagship drug, Ingrezza, continues to deliver double-digit percentage sales growth, while two newer treatments help the company expand beyond its original neurological disease franchise. Neurocrine is also approaching several important clinical milestones, including late-stage trial results for experimental treatments targeting depression and schizophrenia.
By 2031, I expect Neurocrine to be a substantially larger pharmaceutical company, potentially generating more than $6 billion in annual revenue. Whether its stock follows that growth, however, will depend on the success of its newer drugs and how much investors are willing to pay for its earnings.
Ingrezza remains the foundation
If you're unfamiliar, Ingrezza treats tardive dyskinesia, a neurological condition that causes involuntary movements, often associated with long-term use of certain psychiatric medications. It's also approved to treat chorea (involuntary muscle movements) associated with Huntington's disease.
In Q2, Ingrezza sales reached $716 million, up 15% from $624 million a year earlier. Management subsequently raised its full-year 2026 Ingrezza sales forecast to between $2.825 billion and $2.875 billion. And there's still room for more growth.
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Neurocrine estimates that about 800,000 Americans have tardive dyskinesia. Many patients remain undiagnosed or untreated, providing an opportunity to expand prescriptions without requiring another Food and Drug Administration (FDA) approval.
To be sure, Ingrezza does face competition from Teva Pharmaceuticals' (TEVA -1.99%) Austedo, which also treats tardive dyskinesia and Huntington's-related chorea. Future pricing pressure, changes in insurance reimbursement, and eventual generic competition could limit growth. Still, I expect Ingrezza to remain Neurocrine's largest product by 2031, although the company's dependence on it should decline significantly.
Two newer drugs are becoming major revenue contributors
Neurocrine's second-largest product is Crenessity, approved in December 2024 to treat classic congenital adrenal hyperplasia (CAH). This is a rare inherited disorder that interferes with the body's ability to produce certain hormones. Patients often require long-term steroid treatment, which can cause serious complications.
Q2 sales reached $184 million, compared with $53 million a year earlier. That's an increase of 247%. Annualizing the latest quarter produces a revenue run rate of $736 million, although actual full-year sales will depend on continued prescription growth and reimbursement. Neurocrine estimates at least 20,000 Americans have CAH, giving the company a relatively small but commercially meaningful patient population.
Image source: Getty Images.
The company acquired Soleno Therapeutics for about $2.9 billion in May, adding Vykat XR to its portfolio. Vykat XR treats hyperphagia, or persistent, excessive hunger, in patients with Prader-Willi syndrome, a rare genetic disorder.
The drug generated $54 million in sales between the May 18 acquisition closing and June 30. Including sales recorded before the acquisition, the drug generated about $94 million during the full second quarter, equivalent to an annualized revenue run rate of $376 million.
Combined, Crenessity and Vykat XR are already generating more than $1 billion in annualized revenue. Continued adoption could make both significant contributors by 2031.
The pipeline could produce additional blockbusters
Neurocrine has several experimental treatments approaching important clinical milestones. There's Osavampator, which is being evaluated in Phase 3 trials for major depressive disorder, while direclidine is undergoing Phase 3 testing for schizophrenia. Both programs are expected to produce trial results in 2027.
These are considerably larger markets than those targeted by Crenessity and Vykat XR. However, psychiatric drug development carries substantial clinical risk. Both treatments must show meaningful benefits and an acceptable safety profile before Neurocrine can even seek regulatory approval. The company is also developing additional neurological treatments, including experimental drugs targeting Alzheimer's disease and epilepsy.
What could Neurocrine look like in 2031?
Neurocrine's Q2 revenue of $959 million represents an annualized run rate of about $3.84 billion. If annual revenue grows at a compounded rate of 10% from that baseline during the next five years, it would reach about $6.18 billion. A 12% growth rate would produce roughly $6.76 billion.
Those are achievable scenarios if Ingrezza continues growing, Crenessity and Vykat XR expand their patient populations, and at least one late-stage pipeline candidate reaches commercialization.
Neurocrine reported Q2 net income of about $144 million, showing it already has a profitable commercial business to support further research and acquisitions. The biggest risks are really clinical trial failures, rising development expenses, and pricing pressure on Ingrezza.
I expect Neurocrine to generate $6 billion to $7 billion in annual revenue by 2031, with a broader portfolio and less dependence on any single drug. That would represent substantial growth from today's business. But be sure to pay particular attention to the company's 2027 clinical readouts, which could determine whether Neurocrine becomes a much larger neuroscience franchise or remains primarily a three-product pharmaceutical company.
Společnost Neurocrine Biosciences zveřejnila odborný článek o hyperfagii u Praderova-Williho syndromu, který zdůrazňuje význam multidisciplinární péče a označuje VYKAT XR za významný pokrok v léčbě.
Expert perspectives highlight the interaction of hypothalamic dysfunction, biological, behavioral, and environmental factors in shaping the challenges of hyperphagia in Prader-Willi syndrome for patients and families beyond obesity-related complications
The manuscript underscores the importance of multidimensional assessment and integrated care management across the patient lifespan
Experts conclude VYKAT® XR (diazoxide choline) extended-release tablets represent a significant advancement in the treatment of hyperphagia, potentially complementing behavioral and environmental approaches
, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced a publication of expert perspectives highlighting hyperphagia in Prader-Willi syndrome (PWS) as a complex, neurobiologically driven condition that extends beyond excessive hunger and requires comprehensive assessment and management across the patient lifespan. The publication provides insights from an international group of clinical and scientific experts on the evolving understanding of hyperphagia and its implications for the care of people with PWS. The manuscript appears in Orphanet Journal of Rare Diseases.
"Neurocrine is committed to advancing understanding of Prader-Willi syndrome and addressing the needs of individuals and families affected by this complex disorder," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Recognizing hyperphagia as a multifaceted, neurobehavioral condition is essential to understanding its real-world impact on people with PWS and their families. By connecting the underlying disease biology with the daily experience of hyperphagia, these expert perspectives can help inform how best to assess and manage the symptoms and thus support continued progress in care for the PWS community."
The manuscript brings together perspectives from global experts in endocrinology, psychiatry, neuroscience, obesity, genetics, and patient advocacy to advance understanding of hyperphagia in PWS and inform future research and clinical practice. It describes how disruptions in the hypothalamus neural pathways that regulate hunger, fullness, and food-related reward can interact with autonomic dysfunction and environmental factors to shape the varied experience of hyperphagia and its broader effects on individuals and families. Perspectives also outline considerations for assessment and management of hyperphagia and underscore the need for care that integrates biological, behavioral, and environmental approaches across childhood, adolescence, and adulthood. While environmental controls, such as locking cabinets and refrigerators or avoiding social situations where food is present, remain important for managing food access, the publication highlights the need for a more comprehensive approach that addresses the underlying complexity of hyperphagia.
Key themes from the publication include:
Hyperphagia is multidimensional. Experts described hyperphagia as arising from multiple interconnected factors, including changes in how the brain regulates hunger, fullness, and food-related reward, as well as behavioral and environmental factors, with consequences extending beyond food intake alone.
Assessment must capture the full experience. Experts noted that individuals living in highly structured environments may show relatively few observable food-seeking behaviors despite experiencing persistent thoughts about food and a strong drive to eat. As a result, existing assessment tools may underestimate disease severity, as well as success, in some patients. Evaluation should be multidimensional and consider food-related thoughts and behaviors, clinical observations, environmental context, and caregiver perspectives.
Adolescence and transition to adult care are particularly vulnerable periods. Loss of structured support systems, fragmented care, increased independence, and the associated increase in uncertainty, combined with family exhaustion, may contribute to worsening symptoms and increased health risks. Continued expert support is essential to reduce potential clinical complications and maintain quality of life.
Integrated management remains essential. Food security and controlled food environments continue to be foundational therapeutic intervention rather than environment management alone. Experts emphasized the need to combine biological, behavioral, and environmental approaches within multidisciplinary care, with particular attention to vulnerabilities during transition periods.
Pharmacologic treatment can complement foundational support. Medication may lessen the burden of hyperphagia on individuals and caregivers by providing more flexibility in constant management. In this context, VYKAT® XR (diazoxide choline) extended-release tablets represent a significant advancement as the first FDA-approved treatment of hyperphagia in PWS. Pharmacological therapy is an important component of hyperphagia management and should be considered in multidisciplinary care.
"Hyperphagia in Prader-Willi syndrome extends far beyond hunger or food intake. It affects behavior, autonomy, and daily life for individuals living with PWS and their families," said Maithé Tauber, M.D., Professor Emeritus of Pediatrics at Université Toulouse III and lead author of the publication. "Improving care will rely on a truly integrated approach, one that deepens our understanding of the underlying biology, reflects the experience of individuals and their families, and actively engages healthcare teams within well-coordinated systems of care that support patients from birth throughout their lives."
Scientific and clinical experts also identified additional priorities for research and clinical care in PWS, including the development of validated outcome measures for clinical trials, identification of biomarkers, and creation of care models that more closely connect mechanistic insights with real-world clinical practice.
About Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by the loss of expression of specific genes on the paternally inherited copy of 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 neurologically driven by an intense, persistent sensation of hunger and characterized 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.
About VYKAT® XR (diazoxide choline) Extended-Release Tablets
VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients.
VYKAT XR 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 Neurocrine Biosciences, Inc.
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)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. VYKAT and the VYKAT logo are registered trademarks of Soleno Therapeutics, Inc., a Neurocrine Biosciences company.
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 regarding the potential benefits to be derived from VYKAT XR for the treatment of Prader-Willi syndrome (PWS); the value and benefits VYKAT XR brings to patients with PWS; and the potential for the expert perspectives described in the publication to inform future research, clinical practice, and the assessment and management of hyperphagia in PWS. 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 regarding whether the expert perspectives described in the publication will inform future research, clinical practice, or the assessment and management of hyperphagia in PWS; risks and uncertainties associated with our business and finances in general, as well as risks and uncertainties associated with the commercialization of VYKAT XR, including the extent to which patients and physicians accept and adopt VYKAT XR; whether VYKAT XR receives adequate coverage and reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for VYKAT XR; risks associated with dependence on third parties for development and manufacturing activities related to VYKAT XR, and risks associated with managing these third parties; risks that additional regulatory submissions for VYKAT XR may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding VYKAT XR; risks that post-approval commitments or requirements for VYKAT XR may be delayed; risks that VYKAT XR 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; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof except as required by law.
Neurocrine Biosciences zahájila studii fáze 2 přípravku NBI-1117567 (NBI-'567) u zhruba 135 dospělých s mírnou až středně těžkou Alzheimerovou chorobou.
, /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1117567 (NBI-'567) in adults with mild to moderate Alzheimer's disease. NBI-'567 is an orally administered, M1/M4 (M1 preferring) selective muscarinic agonist being evaluated as an adjunctive treatment for cognitive impairment in Alzheimer's disease.
NBI-'567 is designed to directly activate M1 and M4 muscarinic receptors, which are involved in neuronal circuits associated with learning and memory. The study will evaluate the potential of NBI-'567 to improve cognitive performance in adults with mild to moderate Alzheimer's disease who are receiving stable treatment with an acetylcholinesterase inhibitor.
"As a defining characteristic of Alzheimer's disease, cognitive impairment affects memory, attention, and other thinking abilities that significantly impact daily functioning," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "The advancement of NBI-'567 reflects our commitment to delivering new treatment options for this vulnerable population, in addition to our broader strategy to explore the potential of selectively targeting muscarinic receptors across a range of neurological and psychiatric conditions."
This Phase 2 randomized double-blind placebo-controlled study will enroll approximately 135 adults ages 50 to 85 with mild to moderate Alzheimer's disease who are receiving stable treatment with an acetylcholinesterase inhibitor. Participants will be randomized across a high or low dose level of NBI-'567 administered once daily. Over the 12-week treatment period, the study will assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-'567 compared with placebo.
The primary efficacy endpoint is change from baseline in a Neuropsychological Test Battery composite score at Week 12. Secondary endpoints include changes from baseline in ADAS-Cog13 and CDR Sum of Boxes at Week 12.
Visit ClinicalTrials.gov for more information about the study (NBI-1117567-ADC2038).
About Alzheimer's Disease
Alzheimer's disease is a chronic, progressive neurodegenerative disorder and the most common cause of dementia. More than 7 million Americans are living with Alzheimer's disease. The disease causes progressive loss of cognitive function and is associated with behavioral symptoms and a decline in the ability to perform activities of daily living. Alzheimer's disease disrupts multiple neural pathways, including cholinergic signaling, which plays an important role in memory, learning, and other cognitive functions.
About NBI-'567
NBI-'567 is an investigational, orally administered M1/M4 (M1 preferring) selective muscarinic agonist being evaluated as an adjunctive treatment for cognitive impairment in Alzheimer's disease. M1 and M4 muscarinic receptors are involved in neural pathways associated with learning, memory, and other cognitive functions. NBI-'567 is designed to selectively activate these receptors while minimizing activity at other muscarinic receptor subtypes, with the potential to reduce off-target pharmacology-related side effects.
About Neurocrine Biosciences' Muscarinic Portfolio
In addition to NBI-'567, Neurocrine has multiple assets in clinical development that target muscarinic receptors which Neurocrine acquired the rights to develop and commercialize from Nxera Pharma. This includes NBI-1117568 (direclidine) in Phase 3 and Phase 2 for schizophrenia and bipolar mania, respectively; NBI-1117570 in Phase 2 for schizophrenia, and NBI-1117569 in Phase 1 for Alzheimer's psychosis. Neurocrine also is developing NBI-1076986, an investigational selective M4 antagonist discovered and being developed internally for movement disorders.
About Neurocrine Biosciences, Inc.
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 and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
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 regarding the efficacy and therapeutic potential of NBI-'567. 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 that clinical 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 regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; 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 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 U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
Společnost Neurocrine Biosciences analyzovala více než 2 800 relevantních událostí ve zdravotních záznamech 10 dospělých pacientů s klasickou CAH a ukázala, že se potřeby pacientů během života výrazně mění.
Decades of real-world medical records highlight the diverse challenges of living with classic congenital adrenal hyperplasia and how needs evolve from childhood through adulthood Patient records showed growth and bone-age monitoring in childhood; puberty and reproductive health concerns through adolescence and young adulthood; and increasingly diverse clinical needs in adulthood, while treatment and self-management demands persisted across life stages The analysis captured impacts beyond traditional medical complications, including daily activities, school, work, caregiving, self-management, and access to care Mapping patient experiences over time may help healthcare professionals anticipate evolving needs and inform education, support strategies, and coordination across care teams , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new real-world data demonstrating how the clinical and day-to-day impact of classic congenital adrenal hyperplasia can vary among individuals and evolve throughout a patient's life. The findings will be presented at the Endocrine Nurses Society Annual Symposium 2026, taking place Oct. 16-17 in Phoenix.
The analysis used a novel patient journey mapping approach to combine de-identified electronic medical records from CAHtalog®, a registry of patients with classic congenital adrenal hyperplasia (CAH) in the United States developed by Neurocrine in partnership with the CARES Foundation. CAHtalog was designed to characterize treatment patterns over time, natural history, and impact of CAH. The records used for this analysis spanned decades of care across providers, specialties, and health systems, allowing clinical, treatment, monitoring, and humanistic experiences to be examined within individual patients with CAH.
"Classic congenital adrenal hyperplasia is a complex, lifelong disease, and every person living with CAH experiences the condition differently, with needs that change over time," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "By connecting decades of real-world medical records into longitudinal patient journeys, this analysis reveals how the impact of the condition accumulates across the lifespan and highlights challenges that might otherwise be missed in traditional clinical assessments. These insights may help healthcare professionals anticipate periods when patients could benefit from additional education, support, and coordination from their care team."
Electronic medical records from 10 adults (four males, six females) with classic CAH in the CAHtalog registry were used to construct aggregated and sex-stratified patient journeys.* The data comprised more than 2,800 CAH-relevant events representing more than 300 patient-years of medical history. Patient journeys were developed using large language model-assisted analysis and were reviewed and validated by the study team.
Patient records reflected a range of clinical and day-to-day challenges across life stages. Impacts emerged in infancy and centered on diagnosis, treatment, managing acute illness, and preparing caregivers for emergency steroid use. In childhood, records reflected growth-related concerns with bone-age monitoring becoming increasingly important. During adolescence, puberty brought new androgen-related symptoms and challenges with staying on treatment, while monitoring hormone and steroid levels became a greater focus. In young adulthood, new reproductive, surgical, and transition-of-care needs emerged. In adulthood, patients experienced a wider range of health concerns and greater need for imaging and testing.
Treatment, monitoring, caregiver support, and self-management demands recurred and evolved across life stages. Glucocorticoid dose adjustments and stress dosing, or temporarily increasing steroids during illness, injury, or other periods of physical stress, were documented over time in all 10 patients. Records also reflected ongoing monitoring and care coordination, including specialty referrals, changes in providers, treatment access, and the transition to adult endocrinology. Treatment management evolved from caregiver-led support to increasing self-management. These findings underscore ongoing education and preparedness needs for patients and caregivers.
Routine clinical records captured substantial challenges beyond medical complications, extending to school, work, and daily functioning. These impacts evolved over time from challenges managing treatment and progressing in sports during childhood to disruptions in education, work, and physical activity later in life.
While many treatment and weight-related impacts were shared across sexes, the analysis also identified certain sex-specific aspects of care. Menstrual concerns were documented among females, and testicular imaging and testicular adrenal rest tumor concerns were documented among males.
"Nurses are uniquely positioned to understand the full experience of living with adrenal insufficiency — not only the laboratory values and clinical data, but how the condition affects patients and families as they navigate daily life, transitions in care, and changing needs over time," said Louise Fleming, Ph.D., MSN-Ed, RN, FAAN, presenting author and Professor of Nursing at the University of Virginia School of Nursing. "Recognizing the broader patient journey can help us anticipate when additional education, stress-dosing preparation, self-management support or care coordination may be needed. It also allows us to move beyond responding to individual clinical encounters toward providing more proactive, coordinated and patient-centered care across the lifespan."
*This descriptive analysis was intended to provide qualitative insights into patient experiences rather than quantitative estimates, with some observations based on one or two individuals. The findings are illustrative and should not be interpreted as prevalence estimates or evidence of causality.
Additional Presentations at the Endocrine Nurses Society Annual Symposium 2026 Include:
Long-term Treatment with Crinecerfont Enables Sustained Decreases in Glucocorticoid Doses and Improves Clinical Outcomes in Children and Adolescents with Classic Congenital Adrenal Hyperplasia: 2-Year Results from CAHtalyst® Pediatric
Crinecerfont Improves Cardiometabolic Outcomes in the Context of Sustained Glucocorticoid Dose Reduction: 2-Year Results from the CAHtalyst Adult Study About Congenital Adrenal Hyperplasia
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).
About the CAHtalog® Registry
In 2021, the CARES Foundation, Neurocrine Biosciences and PicnicHealth partnered to establish the CAHtalog (Congenital Adrenal Hyperplasia: Patient and Clinical Outcomes in Real-World Practice Settings) Registry. The CAHtalog Registry is a U.S.-based CAH patient registry, or collection of clinical patient data, for patients with CAH due to 21-hydroxylase deficiency. The database was developed to support patient-centered clinical research to enhance the scientific community's foundational knowledge about CAH, and ultimately help patients who live with the condition. Patients consent to the inclusion of their data in the registry with CAH researchers primarily utilizing de-identified data. For more information about the CAHtalog Registry, please visit CAHtalog.com.
About the CAHtalyst® Studies
The Phase 3 CAHtalyst global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY® (crinecerfont) in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients.
The CAHtalyst Pediatric study included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved.
The CAHtalyst Adult study included 182 adult patients 18 to 58 years of age. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved.
Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing.
About CRENESSITY® (crinecerfont)
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.
Important Information
Approved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
IMPORTANT SAFETY INFORMATION
Do not take CRENESSITY if you:
Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.
CRENESSITY may cause serious side effects, including:
Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.
Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.
Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.
The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds.
These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.
Please see full Prescribing Information.
About Neurocrine Biosciences, Inc.
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)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, CRENESSITY and CAHtalog are registered trademarks of Neurocrine Biosciences, Inc.
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 regarding the interpretation and potential relevance of the data described in this press release, including the extent to which patient journey mapping may help healthcare professionals anticipate evolving needs among patients with classic congenital adrenal hyperplasia (CAH) and inform education, patient support and coordination across care teams; the potential benefits to be derived from CRENESSITY for the treatment of CAH; and the value and benefits CRENESSITY brings to patients with CAH. 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 as to whether the data described in this press release, which are based on records from a limited number of patients, are representative of the broader CAH patient population and whether patient journey mapping will help healthcare professionals anticipate evolving patient needs and inform education, patient support and coordination across care teams; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY 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; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
Neurocrine Biosciences oznámila, že na výroční konferenci FPWR 2026 Annual Research Symposium & Family Conference představí nová data o VYKAT XR u Praderova-Williho syndromu, včetně dlouhodobých reálných výsledků a bezpečnosti. Studie sledují hyperfagii i nežádoucí účinky, jako je retence tekutin a hyperglykemie.
PWS-VISTA observational study will build longitudinal real-world evidence on VYKAT XR use for hyperphagia in Prader-Willi syndrome in routine clinical practice BRAVE-PWS observational study will capture caregiver-reported information to better understand the experience and burden of caring for someone with Prader-Willi syndrome Integrated analysis will further evaluate adverse events of special interest — including fluid retention, hyperglycemia, hirsutism and hypertrichosis — during VYKAT XR treatment , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced research advancing understanding of Prader-Willi syndrome and expanding clinical and real-world evidence for VYKAT® XR (diazoxide choline) extended-release tablets will be presented at the Foundation for Prader-Willi Research (FPWR) 2026 Annual Research Symposium & Family Conference, taking place Oct. 7-10 in Philadelphia.
The research reflects Neurocrine's continued commitment to ongoing education of Prader-Willi syndrome (PWS) and VYKAT XR — the first and only FDA-approved treatment for hyperphagia in people aged 4 years and older living with PWS — through clinical and real-world evidence. It includes:
PWS-VISTA, an ongoing observational study designed to build longitudinal real-world evidence on VYKAT XR use in routine clinical practice, including long-term safety and treatment outcomes. Neurocrine will present baseline demographic and clinical characteristics of PWS patients initiating VYKAT XR. BRAVE-PWS, designed with caregiver and clinician input, is an ongoing observational study intended to capture caregiver-reported information to better understand the experience and burden of caring for someone with PWS. Additional research will examine the timing and occurrence of adverse events of special interest during VYKAT XR treatment, including fluid retention, hyperglycemia, hirsutism and hypertrichosis. "Prader-Willi syndrome is a complex, rare condition that profoundly affects individuals and their families, and continued research is essential to deepening our understanding of PWS and the needs of the community," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "The breadth of research we are presenting at the FPWR Research Symposium & Family Conference reflects our long-term commitment to individuals living with PWS, caregivers, healthcare providers, researchers and the broader PWS community. These findings can help inform how we apply our scientific and clinical expertise to areas of great unmet need."
Neurocrine will share the following oral presentation and posters at the FPWR 2026 Annual Research Symposium & Family Conference. All times are in Eastern time.
Title: Real-World Assessment of GLP-1 Receptor Agonist Utilization and Risk of Gastrointestinal Complications in Prader-Willi Syndrome
Presenting Author: Shawn McCandless, M.D.
Date/Time: Oct. 8, from 9:30 to 9:50 a.m.
Title: Real-World Demographics and Clinical Characteristics of Patients with Prader-Willi Syndrome Initiating VYKAT XR (Diazoxide Choline) Extended-Release Tablets: Baseline Results from the PWS-VISTA Observational Study (Poster Presentation #6)
Presenting Author: Julie Perry, M.D.
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: BRAVE-PWS: Burden and Real-World Assessment of Caregiver Voice and Experiences in Prader-Willi Syndrome—Study Design of an Observational, App-Based Health-Tracking Cohort Study (Poster Presentation #8)
Presenting Author: Christopher Joshi, M.D., MPH
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: Integrated Exposure-Adjusted Analysis of Adverse Events of Special Interest During Diazoxide Choline Treatment for Prader-Willi Syndrome (Poster Presentation #15)
Presenting Author: Sheri Leung, Pharm.D.
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: Mortality Among Patients with Prader-Willi Syndrome (MAP-PWS): An Analysis of Healthcare Utilization in the Year Prior to Death Within a Single U.S. Payer (Poster Presentation #16)
Presenting Author: Raj Gandhi, Pharm.D., MBA
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: Long-Term Reductions of Hyperphagia with Diazoxide Choline Extended-Release (DCCR) in Participants with Prader-Willi Syndrome (Poster Presentation #12)
Presenting Author: Evelien F. Gevers, M.D., Ph.D., FRCPCH
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: Efficacy and Safety of Resuming Diazoxide Choline Extended-Release (DCCR) after 16-week Randomized Withdrawal in Prader-Willi Syndrome (PWS) (Study C614) (Poster Presentation #14)
Presenting Author: Evelien F. Gevers, M.D., Ph.D., FRCPCH
Date/Time: Oct. 7, from 5 to 7 p.m.
Title: Impact of Long-Term Diazoxide Choline Extended-Release (DCCR) Treatment and the Prader-Willi Syndrome Profile Questionnaire (PWSP) (Poster Presentation #13)
Presenting Author: Evelien F. Gevers, M.D., Ph.D., FRCPCH
Date/Time: Oct. 7, from 5 to 7 p.m.
About Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality of chromosome 15 gene expression. 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 neurologically driven by an intense, persistent sensation of hunger and characterized 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.
About VYKAT® XR (diazoxide choline) Extended-Release Tablets
VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients.
VYKAT XR 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 Neurocrine Biosciences, Inc.
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)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SOLENO and VYKAT are registered trademarks of Soleno Therapeutics, Inc.
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 regarding the potential benefits to be derived from VYKAT XR for the treatment of Prader-Willi syndrome (PWS); the value and benefits VYKAT XR brings to patients with PWS; and the Company's plans to advance understanding of PWS and expand clinical and real-world evidence regarding VYKAT XR through the studies and analyses described in this press release. 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 as to whether the Company can successfully conduct the studies and analyses described in this press release and whether such research will advance understanding of PWS and expand clinical and real-world evidence regarding VYKAT XR; risks and uncertainties associated with our business and finances in general, as well as risks and uncertainties associated with the commercialization of VYKAT XR, including the extent to which patients and physicians accept and adopt VYKAT XR; whether VYKAT XR receives adequate coverage and reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for VYKAT XR; risks associated with dependence on third parties for development and manufacturing activities related to VYKAT XR, and risks associated with managing these third parties; risks that additional regulatory submissions for VYKAT XR may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding VYKAT XR; risks that post-approval commitments or requirements for VYKAT XR may be delayed; risks that VYKAT XR 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; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof except as required by law.
3 Biotech Stocks to Watch: Iovance, Neurocrine & VikingNeurocrine Biosciences NASDAQ: NBIX outlined its commercial growth priorities, pricing considerations and pipeline plans during a Morgan Stanley discussion, with CEO Kyle Gano emphasizing the company’s efforts to diversify beyond its largest product, INGREZZA.
Gano said China has become both a competitive force and an increasingly important source of biotech innovation. He said the speed, quality and breadth of science in the region have improved over the past decade, particularly in validated biology. Neurocrine has brought in primarily earlier-stage Chinese assets in recent years, he said.
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Bristol Myers Squibb’s big buys: $18.1 billion in 2 biotech dealsWhile China has not changed Neurocrine’s overall balance between internal research and development and business development, Gano said it has increased the importance of speed and selectivity. Companies must develop efficient plans that can reach the market early while demonstrating differentiation throughout development, he said. Neurocrine may also use the Chinese ecosystem to accelerate development through contract research arrangements or collaborations in which Chinese partners advance programs through early clinical stages.
AI Adoption Focused on Productivity Gano said Neurocrine has made artificial intelligence and machine learning a corporate priority and has deployed OpenAI and Anthropic’s Claude tools across the organization. He differentiated near-term productivity opportunities from longer-term expectations that AI could materially improve research-and-development success rates.
Is Mid-Cap Neurocrine Biosciences A Buy After Blowout Q3 Report?According to Gano, employees are using the tools to accelerate workflows, analyze large data sets, reduce repetitive tasks and improve access to information across teams. He cited applications in medicinal chemistry, chemical development, translational science, clinical development and clinical-trial execution.
The company plans to assess AI through measurable outcomes, including whether it can speed decisions, reduce costs, improve clinical-trial enrollment and allow Neurocrine to advance more science without proportionately increasing headcount. Gano said AI’s ability to improve probabilities of technical success remains an earlier-stage opportunity, especially because novel biology often lacks the data needed to generate reliable machine-learning outputs.
INGREZZA Pricing and 2029 Medicare Exposure Gano identified Medicare drug-price negotiations as the policy issue most directly affecting Neurocrine. INGREZZA’s maximum fair price is scheduled to be implemented in 2029, while a competing product in the same two-product category will face its negotiated price two years earlier.
Neurocrine has guided 2026 INGREZZA revenue of $2.825 billion to $2.875 billion. Gano said the product’s market continues to grow at a double-digit rate annually and the company has patent protection through 2038. He also pointed to data supporting INGREZZA, including quality-of-life results, remission data showing that 60% of patients on the therapy are symptom-free, and PET data that he said showed target occupancy superior to its competitor.
The company previously expected a 4% to 5% year-over-year net-price decline for INGREZZA, which Gano attributed to contracting completed last year. He said revenue per prescription has remained relatively consistent during the current year. For 2027, Neurocrine expects nominal price concessions to preserve access as its competitor enters the first year of its maximum fair price. The company will also face an increase in the statutory Medicare Part D catastrophic-phase rebate to 5% from 2%.
Gano said INGREZZA should continue generating revenue and volume growth in 2027 and 2028, supported by double-digit volume growth and an estimated 10% penetration of roughly 100,000 patients under the care of a VMAT2 inhibitor. In 2029, however, he said Neurocrine expects INGREZZA revenue to decline after its maximum fair price takes effect. The product’s negotiated discount is expected to fall within a roughly 25% to 34% range from the relevant non-FAMP calculation, he said.
Whether companywide revenue grows through that period will depend in part on CRENESSITY and VYKAT XR, Gano said. He also cited potential future contributions from osavampator and direclidine, as well as Neurocrine’s ability to pursue external business-development opportunities.
CRENESSITY Expansion and VYKAT XR Education CRENESSITY, Neurocrine’s treatment for congenital adrenal hyperplasia, has reached an annualized revenue run rate of about $750 million, Gano said. Todd Tushla, vice president of investor relations, said the launch is only six quarters old and that the company is continuing to learn about the market before providing revenue guidance. He said Neurocrine may revisit the topic ahead of its fourth-quarter call next year.
Tushla said growth is expected to come from both adding prescribers and increasing the number of patients treated per prescriber. The company is seeing use across centers of excellence, pediatric endocrinologists and community endocrinologists. Neurocrine estimates that about one-third of the patient population is pediatric, and a Phase II study in children ages three months to under four years is expected to produce data in 2028.
For VYKAT XR in Prader-Willi syndrome, Gano acknowledged concerns raised in an August statement regarding deaths and adverse events. He said the disease is serious and complex, with multiple comorbidities, higher mortality than the general population and life expectancy cited in the mid-to-late 40s based on published literature.
Gano said Neurocrine has more than 1,400 patient-years of VYKAT XR experience, including patients treated for more than seven years. He said the company’s priority is educating physicians and families on identifying appropriate patients and managing adverse events. VYKAT XR has about a $400 million annualized run rate, according to Gano.
The company has observed a 20% to 25% discontinuation rate over approximately one year of data and views a 25% to 30% steady-state range as appropriate, Gano said. New patient starts and enrollment forms have remained relatively steady in recent quarters.
Pipeline Programs Target Depression, Psychiatry and Obesity Gano said Neurocrine’s direclidine program is being developed in schizophrenia and bipolar mania, reflecting the need for antipsychotic medicines to expand beyond schizophrenia to build larger commercial opportunities. He said the company views the launch trajectory of COBENFY as broadly consistent with other antipsychotics, but noted that expansion into additional indications is important for long-term revenue potential.
For osavampator, Gano highlighted differentiation from esketamine through its oral tablet formulation, at-home administration, lack of monitoring requirements and favorable safety and tolerability profile. The company has three ongoing replicate Phase III trials, each enrolling 200 subjects and comparing a 1-milligram dose with placebo. If enrollment proceeds as planned, Neurocrine expects Phase III data in the second half of next year, a potential NDA submission in 2028 and a possible launch in 2029 if results are positive.
Gano also discussed Neurocrine’s once-weekly CRF2 agonist, 2118, in obesity. The company completed Phase I in May and expects signal-seeking work next year. He said preclinical diet-induced-obesity mouse data showed weight loss comparable to incretins, with weight loss occurring on the fat side rather than muscle, along with cardiac and renal benefits. Because the approach does not use the GLP pathway, Gano said Neurocrine does not expect nausea and vomiting associated with current GLP-based treatments.
About Neurocrine Biosciences (NASDAQ:NBIX)Neurocrine Biosciences, Inc is a biopharmaceutical company focused on discovering, developing and commercializing medicines for neurological, neuroendocrine and psychiatric disorders. The company develops therapies for conditions with significant unmet medical needs, using expertise in neuroscience and endocrine biology.
Its primary commercial product is INGREZZA (valbenazine), a vesicular monoamine transporter 2 inhibitor approved in the United States for the treatment of tardive dyskinesia and chorea associated with Huntington's disease.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Crenessity od Neurocrine Biosciences utržil v první polovině roku 2026 337 milionů USD, meziročně zhruba o 400 % více. Přibližně 15 % diagnostikovaných pacientů s klasickou CAH už lék dostává, takže prostor pro další růst zůstává.
Key Takeaways Crenessity sales hit $337 million in the first half of 2026, up roughly 400% year over year.About 15% of diagnosed classic CAH patients have been prescribed Crenessity, leaving room to expand.Vertex's planned $10 billion Crinetics deal could strengthen a key rival currently advancing phase III. Neurocrine Biosciences (NBIX - Free Report) continues to rely heavily on its blockbuster VMAT2 inhibitor, Ingrezza, for top-line growth. Still, the company is making meaningful progress beyond the drug as Crenessity gains traction in classic congenital adrenal hyperplasia (CAH), a rare genetic condition involving the adrenal glands.
Launched in December 2024, Crenessity is an oral therapy designed to reduce excessive adrenal androgen production and, in turn, help lower the amount of glucocorticoid (steroid) treatment needed. The drug is emerging as an increasingly important contributor to Neurocrine's commercial portfolio.
Crenessity generated $337 million in sales during the first half of 2026, up roughly 400% year over year and surpassing the $301 million generated in 2025. The strong performance was supported by growing adoption among adult and pediatric patients, with Neurocrine's prescriber base nearly tripling from a year ago. The rapid uptake highlights the drug's increasing contribution to Neurocrine's revenue base and its potential to become a meaningful growth driver alongside Ingrezza.
Neurocrine has not yet provided sales guidance for Crenessity, as the launch remains relatively early and the company continues to learn more about the market and the drug's growth trajectory. About 15% of the estimated diagnosed classic CAH population has now been prescribed the drug, while Neurocrine estimates that at least 20,000 people in the United States have classic CAH. This low penetration leaves substantial room for further adoption and sales expansion. Meanwhile, reimbursement for dispensed prescriptions was approximately 80% in the second quarter, and Neurocrine continues to broaden its reach among pediatric and adult endocrinologists and Centers of Excellence.
Competition Could Pose a Concern for NBIX Over TimeCrenessity's growing presence in the CAH market could face increasing competition from Crinetics Pharmaceuticals’ (CRNX - Free Report) atumelnant, a once-daily oral ACTH receptor antagonist. The drug is currently being evaluated in a phase III study for classic CAH. The competitive threat is becoming more notable following Vertex Pharmaceuticals' (VRTX - Free Report) agreement to acquire CRNX for $10 billion. Announced last month, the deal would bring atumelnant into Vertex's portfolio, providing the candidate with the resources of a larger pharmaceutical company as it advances through late-stage development. The transaction is expected to close in the third quarter of 2026.
Other companies, including Lundbeck Pharmaceuticals and OMass Therapeutics, are also developing potential CAH therapies, though their programs are at earlier stages of development.
NBIX’s Price Performance, Valuation & EstimatesShares of Neurocrine Biosciences have outperformed the industry year to date, as seen in the chart below.
Image Source: Zacks Investment Research
The company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 3.64 times forward 12-month sales, above the industry average of 2.04 times.
Image Source: Zacks Investment Research
Estimate revisions for Neurocrine Biosciences’ 2026 and 2027 EPS have been mixed over the past 30 days.
Image Source: Zacks Investment Research
Neurocrine currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Neurocrine Biosciences ve 2. čtvrtletí zvýšila tržby o 39 % na 959 mil. USD a upravený EPS o 73 % na 2,85 USD, oba výsledky překonaly odhady. Crenessity a Vykat XR dál rozšiřují růst mimo Ingrezza.
Key Takeaways Neurocrine's revenue rose 39% in Q2, while adjusted EPS jumped 73%, beating consensus estimates.Crenessity sales surged about 400%, while Vykat XR adds another rare-disease growth pillar.NBIX trades at a premium sales multiple, with Ingrezza dependence and pipeline risks warranting caution. Neurocrine Biosciences, Inc. (NBIX - Free Report) is pairing rapid earnings and revenue growth with a broader rare-disease portfolio. That operating momentum gives investors a clear fundamental reason to watch the stock.
The trade-off is valuation and execution. NBIX sells at a premium to its sub-industry and the Medical sector on forward sales, while product concentration, competition and pipeline risk argue for a measured view.
NBIX Growth Still Looks StrongSecond-quarter 2026 revenues rose 39% year over year to $959 million, while adjusted earnings advanced 73% to $2.85 per share. The results beat the Zacks Consensus Estimate for earnings of $2.26 per share and for revenues of $901.5 million.
The growth outlook remains elevated. Projected 2026 sales growth is 35.8%, while projected EPS growth is 41.9%. Ingrezza remains the main engine, with first-half 2026 sales up 17% to $1.4 billion and full-year guidance raised to $2.825-$2.875 billion.
Neurocrine Diversifies Beyond IngrezzaCrenessity is becoming a meaningful second growth pillar. First-half 2026 sales reached $337 million, up about 400% year over year and already above the $301 million generated in all of 2025.
Vykat XR adds another rare-disease asset following the Soleno Therapeutics acquisition. It contributed $54 million from May 18 through the end of the second quarter. Management expects launch-related discontinuation effects to largely work through during the third quarter, with sequential sales growth anticipated from the fourth quarter onward.
NBIX Valuation Demands a Closer LookNBIX trades at a forward 12-month price-to-sales ratio of 3.69, versus 2.02 for its sub-industry and 2.23 for the Medical sector. That premium means investors are already paying for faster growth and successful diversification.
The stock still trades below its five-year median forward sales multiple of 5.18. A forward price-to-earnings ratio of 17.15 and PEG ratio of 0.56 make the valuation picture less one-dimensional, but they do not remove the need for continued execution.
Neurocrine Still Faces Execution RisksIngrezza remains the dominant revenue contributor and is exposed to pricing, formulary and policy pressure. Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) markets Austedo and Austedo XR for tardive dyskinesia and chorea associated with Huntington's disease, directly overlapping with Ingrezza's approved markets. A lower negotiated Medicare price for Austedo beginning in 2027 could add pressure on Ingrezza.
Vykat XR also carries retention risk, with management expecting a long-term discontinuation rate of 25-30%. Pipeline execution is another concern after recent clinical setbacks. Bristol Myers Squibb Company (BMY - Free Report) markets Cobenfy for schizophrenia, adding a newer competitor in a market where Neurocrine is advancing phase III candidate direclidine.
NBIX's Mixed Signals Support a Measured ViewFor investors weighing buy, hold or wait, NBIX presents a mixed setup. Growth, diversification and a debt-free balance sheet support the long-term story, but the premium sales valuation, Ingrezza dependence and product-development risks reduce the case for ignoring entry discipline.
The stock currently carries a Zacks Rank #3 (Hold). It also has a Growth Score of A, Value Score of B, Momentum Score of D and VGM Score of A. The Style Scores show favorable growth and value characteristics, but the weak Momentum Score and Zacks Rank #3 make the setup more consistent with a hold-or-wait posture than an aggressive buy case.
Neurocrine Biosciences zvýšila tržby z Ingrezzy v 1. pololetí 2026 o 17 % na 1,4 mld. USD a zvedla celoroční výhled na 2,83–2,88 mld. USD. Růst táhla rekordní nová předpisy a dvouciferný objem.
Key Takeaways Neurocrine's Ingrezza sales rose 17% to $1.4 billion in the first half of 2026.Record new prescriptions and double-digit volume growth drove a higher 2026 Ingrezza sales outlook.Austedo's growth and potential pricing pressure could challenge Ingrezza's momentum over time. Neurocrine Biosciences (NBIX - Free Report) has had an encouraging start so far in 2026, with strong revenue growth, supported by continued momentum in its commercial portfolio. The top-line benefits primarily from Ingrezza, the company's blockbuster VMAT2 inhibitor, which remains Neurocrine’s primary revenue driver and a key pillar of its growth story.
Ingrezza sales rose 17% year over year to $1.4 billion in the first half of 2026, supported by record new prescriptions and double-digit total volume growth. The strong performance prompted management to raise its Ingrezza sales guidance for full-year 2026 to $2.83-$2.88 billion from $2.7-$2.8 billion. The midpoint implies approximately 13% year-over-year growth, indicating that Neurocrine expects the drug's commercial momentum to remain solid through the remainder of the year.
Ingrezza is approved for two indications — tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). However, TD represents the larger commercial opportunity for Ingrezza. Neurocrine estimates that roughly 800,000 people in the United States are affected by the disease, yet only about half are diagnosed and approximately 10% receive a VMAT2 inhibitor, highlighting the significant room for broader treatment adoption. Continued diagnosis and treatment penetration could therefore support Ingrezza's sales growth even as the drug's existing patient base expands.
In comparison, chorea affects the vast majority of the roughly 40,000 Americans living with HD. Although the addressable population is considerably smaller than that for TD, the indication provides an additional source of demand and strengthens Ingrezza's position across the movement-disorder market.
Pricing Exposure Could Become a Concern for NBIX Over TimeWhile Ingrezza continues to benefit from strong volume growth, pricing remains an important consideration for its future sales trajectory. In 2025, pricing concessions related to broader formulary access partially offset volume gains. Although management expects 2026 net pricing to remain broadly consistent with last year's levels, pricing pressure is expected to rise in the longer term.
A key factor could be the pricing of Teva Pharmaceuticals' (TEVA - Free Report) Austedo and Austedo XR, which compete with Ingrezza across both approved indications. TEVA’s therapies are set to enter the Medicare Drug Price Negotiation Program in 2027, with negotiated prices below pre-negotiation levels. This could make Austedo/Austedo XR more price-competitive among Medicare patients and potentially put additional pressure on Ingrezza's pricing and formulary positioning. Neurocrine has said it remains confident in maintaining broad access for Ingrezza, although greater pricing competition could become a concern over time.
At the same time, Austedo is gaining momentum in the market. Teva reported second-quarter 2026 Austedo sales of $696 million, up 40% year over year, underscoring the drug's growing competitive position. Like NBIX, TEVA also raised its 2026 outlook for Austedo to $2.45-$2.60 billion from $2.40-$2.55 billion.
While Austedo remains the most direct competitive threat, the pipeline is also evolving beyond VMAT2 inhibitors. Acadia Pharmaceuticals (ACAD - Free Report) recently started clinical development on ACP-271, a GPR88 agonist for TD. Though this candidate is still in early-stage development, its different mechanism could represent a longer-term competitive consideration for Ingrezza.
NBIX’s Price Performance, Valuation & EstimatesShares of Neurocrine Biosciences have outperformed the industry year to date, as seen in the chart below.
Image Source: Zacks Investment Research
The company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 3.69 times forward 12-month sales, above the industry average of 2.02 times.
Image Source: Zacks Investment Research
Estimate revisions for Neurocrine Biosciences’ 2026 and 2027 EPS have been mixed over the past 30 days.
Image Source: Zacks Investment Research
Neurocrine currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Odborníci na Prader-Willi syndrom varovali před bezpečnostními riziky léku Vykat XR od Neurocrine kvůli hlášeným závažným nežádoucím účinkům, včetně otoků, dýchacích a srdečních komplikací. Akcie Neurocrine v premarketu klesly o 6,1 %.
The offices of Neurocrine Biosciences in San Diego, California, U.S. June 30, 2026. REUTERS/Mike Blake Purchase Licensing Rights, opens new tab
CompaniesAug 12 (Reuters) - Experts in Prader-Willi Syndrome on Tuesday raised safety concerns over Neurocrine's (NBIX.O), opens new tab drug Vykat XR, citing serious adverse events reported in patients with the rare genetic disorder.
Vykat XR was approved last year to treat hyperphagia or feelings of intense and persistent hunger, the hallmark symptom of Prader-Willi syndrome, a genetic disorder caused by deletions on chromosome 15 that affect gene expression, or how genes turn on and off.
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In a joint statement, Foundation for Prader-Willi Research and the International Prader-Willi Syndrome Organisation said serious adverse events - including edema, respiratory complications and cardiac complications - had been reported through post-marketing surveillance since Vykat XR became more widely available.
Neurocrine shares fell 6.1% in premarket trading on Wednesday.
According to the statement, the U.S. Food and Drug Administration's Adverse Event Monitoring System (AEMS) showed seven reports of death linked to patients taking the drug as of July 31.
Peripheral edema and the drug being ineffective were the highest reported reactions on FDA's AEMS.
"VYKAT XR has a compelling risk-benefit profile in the context of a very serious disease. Neurocrine conducted extensive diligence on the safety profile, including adverse event data, during our process to acquire Soleno," said Neurocrine.
It added it is "engaged with the FDA, patient advocacy communities and prescribers to continue to assess all available data from postmarketing surveillance as the prescribing population expands."
Earlier this year, Neurocrine bought Soleno for $2.9 billion, gaining access to Vykat XR.
The joint statement said the reports were concerning and patients and families deserved transparency regarding the drug's safety profile.
They stressed, however, the reports do not establish a causal relationship between Vykat XR and the reported outcomes.
"The purpose of this new statement is not to discourage the use of VYKAT XR. Rather, it is to encourage informed prescribing, careful patient selection, and close monitoring, particularly for individuals with known risk factors," the statement said.
Stat News was the first to report on the matter.
Reporting by Puyaan Singh in Bengaluru, additional reporting by Sriparna Roy; Editing by Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Neurocrine Biosciences uvedla, že INGREZZA v 24týdenní studii zlepšila kvalitu života a každodenní fungování pacientů s tardivní dyskinezí. Přibližně 58 % pacientů dosáhlo remise příznaků.
INGREZZA is the only vesicular monoamine transporter 2 inhibitor with clinical trial data demonstrating improvements in quality of life and functionality in people living with tardive dyskinesia across multiple validated patient-reported outcomes Mean improvements in the patient-reported impacts of tardive dyskinesia and clinician-rated movement severity exceeded established thresholds for clinically meaningful change at Week 24, with improvements observed regardless of underlying psychiatric diagnosis or baseline movement severity Approximately 58% of patients met the threshold for tardive dyskinesia symptomatic remission at Week 24, based on clinician assessment of movement severity Findings reinforce that even patients with mild tardive dyskinesia movements are impacted and can experience meaningful improvements in movement severity, quality of life and functionality with INGREZZA treatment , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of the KINECT-PRO™ Phase 4 open-label study results demonstrating that treatment with once-daily INGREZZA® (valbenazine) capsules resulted in substantial and sustained improvements in patient-reported quality of life and functionality, alongside improvements in clinician-rated tardive dyskinesia (TD) movement severity. Improvements were observed regardless of underlying psychiatric diagnosis or baseline TD movement severity, including among participants with clinician-rated mild TD movements. The manuscript appears in CNS Spectrums.
KINECT-PRO is currently the only study to assess the effects of a vesicular monoamine transporter 2 (VMAT2) inhibitor (INGREZZA) on quality of life and functionality using multiple validated patient-reported outcomes (PROs), including the Tardive Dyskinesia Impact Scale (TDIS™). TDIS, developed by Neurocrine Biosciences in partnership with thought leaders in neurology and psychiatry, is a unique, psychometrically validated tool that measures the impact and burden of TD from a patient's perspective. Together with clinician-rated assessments, these findings provide a more comprehensive understanding of how treatment may affect both TD movements and the impact of the disease on patients' daily lives.
"The KINECT-PRO clinical study incorporated validated patient-reported measures, including the Tardive Dyskinesia Impact Scale, to better understand the effects of treating tardive dyskinesia with INGREZZA on patient-reported quality of life and functioning," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These findings add to the extensive body of evidence supporting the meaningful improvements INGREZZA has on movement severity and quality of life and functionality."
"Quality of life and day-to-day functioning are important considerations when evaluating the impact of tardive dyskinesia and treatment goals," said Christoph U. Correll, M.D., Professor of Psychiatry, The Zucker Hillside Hospital and primary author of the manuscript. "These findings showed improvements with INGREZZA in both clinician-rated movement severity and patient-reported daily impact and reinforced the potential for meaningful benefit across a broad range of patients regardless of baseline movement severity or underlying psychiatric diagnosis."
KINECT-PRO evaluated improvements in outcomes that matter to patients
The primary endpoints of KINECT-PRO were changes from baseline to Week 24 in three validated patient-reported measures of quality of life and functionality, including:
TDIS: Measures the physical, social and emotional impacts of TD. EuroQoL Visual Analogue Scale (EQ-VAS): Measures patients' self-rated overall health status. The Sheehan Disability Scale (SDS): Measures patient-reported functional impairment in work/school, social life and family/home life. Secondary endpoints evaluated clinician- and patient-reported changes in TD severity using the Abnormal Involuntary Movement Scale (AIMS), the Patient Global Impression of Change (PGI-C) and the Clinical Global Impression of Severity-TD (CGI-TD-S). Fifty-nine patients were enrolled in the KINECT-PRO study and received once-daily INGREZZA (40 mg, 60 mg or 80 mg) for up to 24 weeks. At baseline, approximately 41% of patients (24/59) had clinician-rated mild TD movement severity, while approximately 59% (35/59) had clinician-rated moderate or severe TD movement severity. Approximately 46% of patients (27/59) had schizophrenia or schizoaffective disorder, and approximately 54% (32/59) had major depressive disorder or bipolar disorder. Fifty-two patients completed the Week 24 visit.
Patients experienced improvements in quality of life, functionality and movement severity
KINECT-PRO participants experienced substantial improvements across the three validated patient-reported measures of quality of life (TDIS, SDS and EQ-VAS), as well as improvements in clinician-reported TD severity.
Mean improvements in TD impact (TDIS) and movement severity (AIMS) exceeded established minimal clinically important difference (MCID) thresholds as early as Week 8 and Week 4, respectively, and were sustained to Week 24. Improvements were observed regardless of underlying psychiatric condition or TD movement severity at baseline. Even patients with milder clinician-rated TD movement severity were impacted by TD at baseline and experienced clinically meaningful improvements by Week 24, including a -6.8 mean change from baseline in TDIS and a -5.6 mean change from baseline in AIMS. Approximately 58% of patients (26/45) met the threshold for TD symptomatic remission at Week 24, defined as a movement severity score of 0 ("none") or 1 ("minimal") in each of the seven body regions assessed by AIMS. Safety and tolerability of treatment were consistent with the known profile of INGREZZA, with no new concerns identified.
Mean Change from Baseline at Week 24
TDIS†
(MCID -4)
SDS -
Social Life†
SDS -
Family Life†
EQ-VAS‡
AIMS Total
Score†
(MCID -2)
Overall Population
(n=45)*
-8.0
-2.3
-1.6
+13.1
-6.8
Mild TD Subgroup
(n=20)
-6.8
-1.8
-1.3
+12.8
-5.6
Moderate/Severe
TD Subgroup
(n=25)
-8.9
-2.8
-1.8
+13.3
-7.8
*52/59 (88%) completed the Week 24 visit; 45 were included for efficacy analyses.
†A decrease in score indicated improvement.
‡An increase in score indicated improvement.
About the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies.
KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and psychometrically validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition.
About the Tardive Dyskinesia Impact Scale
The Tardive Dyskinesia Impact Scale (TDIS™) is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. It was developed by Neurocrine Biosciences in partnership with thought leaders in neurology and psychiatry from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT® 3 and KINECT® 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six scales are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes.
About the EQ Visual Analogue Scale and the Sheehan Disability Scale
The EQ Visual Analogue Scale (EQ-VAS) is the second component of the 5-level EQ 5D (EQ-5D-5L). The EQ-VAS is a visual scale ranging from 0 "the worst health you can imagine" to 100 "the best health you can imagine" that assesses a patient's self-rated health, with higher scores indicating better health status.
The Sheehan Disability Scale (SDS) is a five-item, patient-reported outcome measure which includes social, family and occupational life domains. Three items assess impairment in terms of work/school, social life and family life/home responsibilities and are scored independently (0 [not impaired] to 10 [extremely impaired]) or combined for a total score (0 to 30). Two items assess number of days lost or underproductive. A decrease in score indicates improvement.
About Tardive Dyskinesia
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.
About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration.
INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.
INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:
movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
Do not take INGREZZA or INGREZZA SPRINKLE if you:
are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:
Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
About Neurocrine Biosciences, Inc.
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)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO and TDIS are trademarks of Neurocrine Biosciences, Inc.
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 regarding the potential benefits to be derived from INGREZZA, the interpretation and potential relevance of the data described in this press release, including statements regarding clinically meaningful improvements in patient-reported quality of life and functional capacity and clinician-rated movement severity among patients with tardive dyskinesia, and the value INGREZZA may bring to patients. 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 as to whether the data described in this press release will be replicated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA 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; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
Neurocrine Biosciences zahájila fázi 1 první klinické studie NBIP-1968, trojitého agonisty GLP-1/GIP/glukagonu pro léčbu obezity. Studie bude hodnotit bezpečnost a snášenlivost jednorázově zvyšovaných dávek u dospělých účastníků napříč kategoriemi BMI, včetně nadváhy a obezity.
Initiation of study marks an important milestone in advancing Neurocrine's obesity portfolio and investigational metabolic disease pipeline , /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity.
"Obesity is a complex chronic disease driven by multiple biological pathways, underscoring the need for additional treatment options," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "NBIP-'1968 is designed to engage three complementary metabolic mechanisms, reflecting our commitment to exploring multiple scientific approaches to obesity."
The Phase 1 study initially will evaluate the safety and tolerability of single ascending doses of NBIP-'1968 in adult participants across a range of body mass index categories, including overweight and obese.
NBIP-'1968 is an internally discovered, investigational long-acting triple agonist designed for once-weekly subcutaneous administration. It targets the receptors for glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon to influence metabolic pathways involved in appetite regulation, energy balance and glycemic control. NBIP-'1968 was designed with balanced glucagon receptor activity to optimize the potential metabolic benefits of glucagon receptor activation while supporting tolerability.
Neurocrine is developing NBIP-'1968 as part of a broader obesity portfolio that includes NBIP-'2118, an investigational corticotropin-releasing factor type 2 receptor agonist currently in Phase 1 development. NBIP-'1968 is intended for use in a fixed-dose combination with NBIP-'2118. The company's obesity research also includes earlier-stage programs designed to explore complementary mechanisms and extended dosing intervals.
"Advancing NBIP-'1968 into the clinic marks another important step in building our obesity portfolio," said Jude Onyia, Ph.D., Chief Scientific Officer, Neurocrine Biosciences. "Our strategy is to explore complementary and differentiated mechanisms that may improve weight loss, preserve lean mass and ultimately address the diverse needs of people living with obesity."
About Obesity
Obesity is a chronic disease characterized by excess body fat and is associated with serious health conditions, including type 2 diabetes, cardiovascular disease, obstructive sleep apnea, metabolic dysfunction-associated steatohepatitis/fatty liver disease, certain cancers and osteoarthritis. It is driven by complex biological, environmental, and genetic factors – not simply lifestyle or willpower. Obesity has reached epidemic levels worldwide, affecting a significant proportion of adults and placing a substantial burden on public health systems. Despite recent advances in treatment, there remains a need for additional therapies that support safe, effective and sustainable long-term weight management. Current therapies can have challenges with respect to gastrointestinal tolerability, dose titration, and muscle loss.
About Neurocrine Biosciences, Inc.
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 and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
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 regarding the efficacy and therapeutic potential of NBIP-'2118, NBIP-'1968 and other preclinical programs for obesity. 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 that clinical 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 regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; 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 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 U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
Neurocrine Biosciences ve 2. čtvrtletí vykázala zisk 2,85 USD na akcii a tržby 959 mil. USD, obojí nad odhady. Zisk meziročně vzrostl z 1,06 USD na akcii.
Neurocrine Biosciences (NBIX - Free Report) came out with quarterly earnings of $2.85 per share, beating the Zacks Consensus Estimate of $2.26 per share. This compares to earnings of $1.06 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +26.11%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.68 per share when it actually produced earnings of $1.94, delivering a surprise of +15.48%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Neurocrine, which belongs to the Zacks Medical - Drugs industry, posted revenues of $959 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.37%. This compares to year-ago revenues of $687.5 million. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Neurocrine shares have added about 27.5% since the beginning of the year versus the S&P 500's gain of 6.9%.
What's Next for Neurocrine?While Neurocrine has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Neurocrine was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.47 on $1.01 billion in revenues for the coming quarter and $9.09 on $3.77 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Theravance Biopharma (TBPH - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026.
This biopharmaceutical company is expected to post quarterly earnings of $0.19 per share in its upcoming report, which represents a year-over-year change of +337.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Theravance Biopharma's revenues are expected to be $19.79 million, down 24.4% from the year-ago quarter.
Neurocrine Biosciences má za 2. čtvrtletí vykázat tržby 901,54 milionu USD a zisk na akcii 2,26 USD. Investoři budou sledovat hlavně prodeje Ingrezza a Crenessity i integraci Vykat XR.
Key Takeaways NBIX is expected to post Q2 revenues of $901.54 million and earnings of $2.26 per share.Neurocrine expects Ingrezza and Crenessity to support quarterly growth through demand and adoption.NBIX investors will watch pipeline updates and the integration of newly acquired Vykat XR. Neurocrine Biosciences (NBIX - Free Report) is scheduled to report second-quarter 2026 results on July 30, after market close. We expect investors to focus on the sales performance of NBIX’s marketed products and other pipeline updates when the company reports quarterly results.
The Zacks Consensus Estimate for second-quarter 2026 revenues is pegged at $901.54 million, while the same for earnings is pegged at $2.26 per share.
Over the past six months, shares of NBIX have risen 30.5% against the industry’s 4.1% decline.
Image Source: Zacks Investment Research
Let’s see how things might have shaped up for NBIX in the to-be-reported quarter.
Factors Likely to Influence NBIX’s Q2 ResultsNeurocrine’s top line primarily comprises product sales from Ingrezza and Crenessity with only a modest contribution from other revenue streams. Ingrezza, the company's flagship VMAT2 inhibitor, continues to anchor revenue growth with its leadership in the tardive dyskinesia market, while benefiting from its expanded indication in Huntington's disease chorea. Meanwhile, Crenessity is emerging as an important growth driver following its FDA approval in late 2024 for use as an adjunctive treatment for classic congenital adrenal hyperplasia (CAH) in adults and children aged four years and older.
We expect Ingrezza to sustain its solid commercial momentum in the upcoming quarter, supported by robust prescription demand. Management's reaffirmation of its full-year sales guidance of $2.7-$2.8 billion reflects continued confidence in the product's growth trajectory. Meanwhile, Crenessity is expected to deliver another quarter of sequential growth, driven by increasing physician adoption, expanding reimbursement coverage and rising patient uptake. Collectively, these products are likely to underpin Neurocrine's second-quarter commercial performance.
Beyond its commercial portfolio, investors are likely to focus on updates across Neurocrine's diversified neuroscience pipeline, which remains a key driver of the company's long-term growth strategy. Particular attention will be on the phase III development of direclidine for schizophrenia, alongside its mid-stage evaluation in bipolar mania, as well as the late-stage development of osavampator for major depressive disorder with cognitive impairment.
Investors will also look for updates on Crenessity's expansion, following the initiation of a phase II study in younger pediatric patients (less than four years) with classic CAH and the completion of enrollment in a separate phase II study in the European Union involving children from birth to under two years of age.
Another area of focus will be the Soleno Therapeutics acquisition, completed in May 2026. The transaction added Vykat XR (diazoxide choline), the first and only FDA-approved treatment for hyperphagia associated with Prader-Willi syndrome in adults and pediatric patients aged four years and older, to Neurocrine's commercial portfolio. Supported by patent protection extending into the mid-2040s, the acquisition is expected to strengthen the company's commercial platform and enhance its long-term growth profile.
Earnings Surprise HistoryNeurocrine has a mixed history of earnings surprises. The company’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, delivering an average surprise of 9.08%. In the last reported quarter, the company delivered an earnings surprise of 15.48%.
Earnings Whispers for NBIXOur proven model does not conclusively predict an earnings beat for NBIX this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter.
Earnings ESP: Neurocrine has an Earnings ESP of -7.61% as the Most Accurate Estimate currently stands at $2.08 per share and the Zacks Consensus Estimate of earnings is pegged at $2.26.
Zacks Rank: Neurocrine currently carries a Zacks Rank #2.
You can see the complete list of today’s Zacks #1 Rank stocks here.
Stocks to ConsiderHere are a few stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle.
Harmony Biosciences (HRMY - Free Report) has an Earnings ESP of +14.14% and sports a Zacks Rank #1 at present.
Shares of HRMY have lost 4.2% over the past six months. The company’s earnings missed estimates in each of the trailing four quarters, delivering a negative average surprise of 25.16%.
ACADIA Pharmaceuticals (ACAD - Free Report) has an Earnings ESP of +25.00% and carries a Zacks Rank #2 at present.
Shares of ACAD have lost 3.1% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 20.83%.
Agios Pharmaceuticals (AGIO - Free Report) has an Earnings ESP of +12.67% and holds a Zacks Rank #3 at present.
Shares of AGIO have risen 28.4% over the past six months. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 2.39%.
Neurocrine Biosciences čeká na výsledky za čtvrtletí s odhadovaným ziskem na akcii 2,24 USD a tržbami 894,32 mil. USD. Oproti loňsku by to znamenalo meziroční růst zisku o 111,3 % a tržeb o 30,1 %.
Wall Street expects a year-over-year increase in earnings on higher revenues when Neurocrine Biosciences (NBIX - Free Report) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.
The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on July 30. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis biopharmaceutical company is expected to post quarterly earnings of $2.24 per share in its upcoming report, which represents a year-over-year change of +111.3%.
Revenues are expected to be $894.32 million, up 30.1% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Neurocrine?For Neurocrine, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +3.77%.
On the other hand, the stock currently carries a Zacks Rank of #1.
So, this combination indicates that Neurocrine will most likely beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Neurocrine would post earnings of $1.68 per share when it actually produced earnings of $1.94, delivering a surprise of +15.48%.
Over the last four quarters, the company has beaten consensus EPS estimates three times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Neurocrine appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
An Industry Player's Expected ResultsAnother stock from the Zacks Medical - Drugs industry, Ionis Pharmaceuticals (IONS - Free Report) , is soon expected to post loss of $0.91 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -205.8%. Revenues for the quarter are expected to be $189.93 million, down 58% from the year-ago quarter.
The consensus EPS estimate for Ionis Pharmaceuticals has been revised 4.1% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +3.30%.
This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Ionis Pharmaceuticals will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Neurocrine vykázala tržby z Ingrezza na 656,9 mil. USD, meziročně o 20 %, a potvrdila celoroční výhled na rok 2026 na 2,7–2,8 mld. USD. Zároveň rozšiřuje portfolio po akvizici Soleno přidáním Vykat XR.
Key Takeaways NBIX is driving growth with rising Ingrezza sales, increasing Crenessity uptake & reaffirmed 2026 guidance. NBIX advanced its late-stage and early-stage programs across schizophrenia, TD and obesity. Neurocrine added Vykat XR through the Soleno acquisition, expanding its commercial rare disease portfolio. Neurocrine Biosciences (NBIX - Free Report) continues to strengthen its growth profile through the solid commercial performance of its marketed therapies, a steadily advancing late-stage neuroscience pipeline and strategic business development initiatives.
Strong Commercial Performance Aids NBIX’s GrowthNeurocrine is making steady progress, with strong commercial performance from its two marketed drugs, Ingrezza and Crenessity (crinecerfont). Ingrezza, the first FDA-approved VMAT2 inhibitor for tardive dyskinesia (TD), has remained the company's flagship product since its launch in 2017. The therapy established market leadership in TD and expanded its commercial opportunity with its approval for the treatment of Huntington's disease chorea in 2023. In the first quarter of 2026, the drug generated net product sales of $656.9 million, up 20% year over year, driven by double-digit prescription growth and record new patient starts. Management reaffirmed its full-year 2026 Ingrezza sales guidance of $2.7-$2.8 billion, highlighting continued confidence in the product's growth trajectory.
Neurocrine's second commercial product, Crenessity (crinecerfont), is also emerging as an important growth contributor. In December 2024, the FDA approved Crenessity as an adjunctive treatment to glucocorticoid replacement therapy to control androgen levels in adult and pediatric patients aged four years and older with classic congenital adrenal hyperplasia (CAH). Since its launch, the drug has delivered consistent quarter-over-quarter commercial growth, supported by robust physician adoption, increasing patient demand and expanding reimbursement coverage.
Year to date, shares of NBIX have risen 22.9% against the industry’s 2.9% decline.
Image Source: Zacks Investment Research
Robust Pipeline Supports NBIX’s Long-Term Growth OutlookBeyond its marketed products, Neurocrine continues to strengthen its long-term growth outlook through a robust and diversified neuroscience pipeline spanning multiple high-value indications.
The company's lead late-stage candidate, direclidine (NBI-1117568), is in phase III development for schizophrenia while also being evaluated in a mid-stage study for bipolar mania. Another promising late-stage asset, osavampator (NBI-1065845), is being developed for major depressive disorder with cognitive impairment, a condition with substantial unmet medical need.
Neurocrine is also expanding the commercial opportunity for Crenessity through additional clinical development. The company initiated a phase II study this month to assess the safety and tolerability of Crenessity in pediatric patients younger than four years with classic CAH and completed target enrollment in a separate European Union phase II study involving children from birth to under two years of age. Successful development in these younger patient populations could further broaden the drug's addressable market.
The company has continued to advance its early-stage pipeline. During the year, Neurocrine initiated phase II studies evaluating NBI-1117570 for schizophrenia and NBI-1065890, a next-generation VMAT2 inhibitor for tardive dyskinesia. It also started a first-in-human phase I study of NBIP-2118, a first-in-class therapy for obesity.
These pipeline advancements strengthen Neurocrine's prospects for sustained innovation and long-term revenue growth across the neuroscience and rare disease markets.
Soleno Acquisition Strengthens NBIX's Commercial PortfolioThe company enhanced its long-term growth strategy through the acquisition of Soleno Therapeutics in May. The acquisition added Soleno’s Vykat XR (diazoxide choline), a first-in-class treatment for hyperphagia associated with Prader-Willi syndrome (PWS), to Neurocrine’s commercial portfolio. It is the first and only FDA-approved therapy for hyperphagia in adults and pediatric patients four years of age and older with PWS. Backed by a robust intellectual property portfolio extending into the mid-2040s, the therapy offers a sustainable platform for long-term value creation.
NBIX's Zacks Rank & EstimatesNeurocrine currently sports a Zacks Rank #1 (Strong Buy). Over the past 60 days, earnings per share estimates for Neurocrine have risen from $8.04 to $9.47 for 2026 and from $9.54 to $10.79 for 2027.
Other Stocks to ConsiderSome other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents per share. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 6.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 17.3% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have surged 128.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Neurocrine Biosciences zahájila fázi 2 studie crinecerfontu u dětí od 3 měsíců do 4 let s klasickou kongenitální adrenální hyperplazií. Studie má ověřit bezpečnost a snášenlivost u 20 účastníků.
, /PRNewswire/ -- 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. For more information, visit ClinicalTrials.gov.
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.
About Congenital Adrenal Hyperplasia
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).
About CRENESSITY® (crinecerfont)
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.
Important Information
Approved Uses
CRENESSITY® (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
IMPORTANT SAFETY INFORMATION
Do not take CRENESSITY if you:
Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.
CRENESSITY may cause serious side effects, including:
Allergic reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.
Risk of Sudden Adrenal Insufficiency or Adrenal Crisis with Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine.
Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.
The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nosebleeds.
These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.
Please see full Prescribing Information.
About Neurocrine Biosciences, Inc.
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. 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 and CRENESSITY are registered trademarks of Neurocrine Biosciences, Inc.
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 regarding our future development plans with respect to crinecerfont; the efficacy and therapeutic potential of crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH); and the value and benefits CRENESSITY brings to adults and pediatric patients 4 years of age and older with CAH. 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 that clinical 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 regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; 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 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 U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
