Dopamine hydrochloride

InBrain Pharma Secures €1.8 Million in Funding for the PERCEPAR Project under France 2030’s “First Factory” Initiative to Industrialize Anaerobic Dopamine Production for Parkinson’s Disease Lille, May 12, 2025 – InBrain Pharma, a clinical stage biotech specialized in therapeutic solution development against neurodegenerative diseases, is thrilled to announce that it has been selected as a winner of the “First Factory” call for projects operated by Bpifrance on behalf of the French State, as part of the France 2030 plan. The funding supports its PERCEPAR project (PERfusion CErébrale de dopamine, a therapeutic innovation for PARkinson’s patients), which aims to industrialize the manufacturing process of anaerobic dopamine (A-dopamine). As part of this initiative, InBrain Pharma has entered a strategic subcontracting partnership with IDD-Xpert, a CDMO (Contract Development and Manufacturing Organization) specializing in the galenic development and production of innovative drugs. Backed by €1.8 million in funding, this pioneering project aims to scale up the anaerobic dopamine production process — initially to produce clinical batches for the upcoming Phase III trial starting in 2026, and later to manufacture commercial batches required for commercialization. Since 2020, A-dopamine has been prepared by the Hospital Pharmacy of Lille University Hospital. The PERCEPAR project represents an important step in InBrain Pharma's scale-up and efforts to bring to market its novel brain infused dopamine, which is already considered essential for advanced Parkinson’s disease management and expected to challenge current therapeutic dogma in this disease. Dr. Véronique Foutel, President of InBrain Pharma, stated: “We would like to thank the French government for selecting our project under the France 2030 ‘First Factory’ call. By partnering with IDD-Xpert, we have found the ideal industrial partner to scale up our manufacturing process and meet the highest quality standards. Together, we will be laying the foundation for a new manufacturing sector dedicated to sterile injectable drugs requiring extremely strict anaerobic conditions. We are also delighted that this industrialization can take place in a French territory renowned for its pharmaceutical excellence and contribute to further strengthening France’s industrial sovereignty in the manufacturing of cutting-edge therapeutic solutions addressing public health priorities.” A Strategic Partnership with IDD-Xpert To set up and develop a GMP-compliant production of A-dopamine, InBrain Pharma has teamed up with IDD-Xpert, a pharmaceutical subcontractor based in Evreux (Eure). Specializing in injectable solutions, IDD-Xpert has cutting-edge expertise in the manufacture of innovative drugs under complex conditions. Anaerobic dopamine production requires rigorous control of oxygen leves, while complying with sterility standards — a technical challenge few CDMOs worldwide can meet. Dr. Matthieu Fisichella, CSO and co-founder of InBrain Pharma, added: “After consulting more than 40 pharmaceutical manufacturing experts, we are thrilled to have found the best-suited CDMO for our drug candidate right here in France. IDD-Xpert is a highly skilled and innovation-driven partner, essential for the success of our unique anaerobic dopamine project.” Laurence Benissan, CEO of IDD-Xpert, commented: “This project highlights the importance of innovation in the pharmaceutical sector and represents a true revolution in Parkinson’s disease patient management. We are proud to contribute to it. Manufacturing A-dopamine under strict anaerobic conditions, in line with Annex 1 of GMP for sterile products, is a bold technical challenge we are confident to meet thanks to our expertise.” Virginie Fontaine, Health Sector Innovation Manager at Bpifrance, concluded: “We are delighted to support the PERCEPAR development project through France 2030. InBrain Pharma’s unique expertise in cerebral A-dopamine infusion, combined with IDD-Xpert’s manufacturing know-how, makes this an impactful industrial program addressing a major medical need and reinforcing France’s sovereignty. Innovation in central nervous system treatments is a key health priority for the French State.” A Technical Challenge in the Service of a Major Therapeutic Innovation for Advanced Parkinson’s disease Parkinson’s disease, caused by the degeneration of dopaminergic neurons, leads to severe motor impairments due to dopamine deficiency in the brain. Until the recent validation of the clinical proof-of-concept supporting the use of A-dopamine in 2024 by the DIVE-1 study results, only L-Dopa-based drugs or dopaminergic agonists were used in this context, as conventional dopamine does not cross the digestive or blood-brain barrier when swallowed or injected. The InBrain Pharma’s anaerobic dopamine formulation enables a circadian brain infusion of the neurotransmitter, lifting a scientific lock that has held for half a century. At launch, A-dopamine will be reserved to the management of patients who have become refractory to oral antiparkinsonian therapies and subject to inadequate motor symptom control which corresponds to two-thirds of patients with advanced Parkinson’s disease patient pool in major pharmaceutical markets. Consequently, the continuous A-dopamine brain infusion is expected to address a high unmet medical need. Economic and Industrial Impact Beyond short-term job creation, the project’s success could lead to the establishment of a new IDD-Xpert facility dedicated to commercial batch manufacturing. For its part, InBrain Pharma will be expanding its team by recruiting in the fields of the regulatory affairs and the CMC. The PERCEPAR project is the second major milestone achieved by the biotech in recent months, following the publication of the exceptional therapeutic benefit of its drug candidate in Nature Medicine. These two achievements bring the new drug closer to market, with launch scheduled for the beginning of the next decade. About InBrain Pharma InBrain Pharma is positioning itself as a pioneer in personalized medicine in neurology, titrating dopamine in the brain by circadian intracerebroventricular infusion to treat patients with advanced-stage Parkinson’s disease. Founded in 2018, InBrain Pharma is a biopharmaceutical company that holds an exclusive global license from SATT Nord to exploit the patents covering this groundbreaking therapeutic approach for Parkinson’s disease. This innovation is based on the research conducted by Professors David Devos and Caroline Moreau within their academic team at the University of Lille, Lille Neuroscience & Cognition UMR-S 1172 INSERM, and Lille University Hospital. In July 2024, Professors Devos and Moreau were finalists for the 2024 European Inventor Award in the Research category, awarded by the European Patent Office. InBrain Pharma has also received the University of Lille Foundation Prize, was a winner of the i-Lab competition, and has been supported through the Deeptech initiative. About IDD-Xpert IDD-Xpert is a CDMO (Contract Development and Manufacturing Organization) based in Evreux, France, specializing in galenic development and manufacturing of innovative drugs, particularly injectable solutions for the pharmaceutical and biotechnology sectors. Since its inception in 2012, IDD-Xpert has built a strong reputation for its expertise in formulating small synthetic chemical and biological molecules, meeting the specific needs of 400 mostly international customers while guaranteeing the compliance with the stringent quality standards of the pharmaceutical industry. By collaborating with InBrain Pharma on the PERCEPAR project, IDD-Xpert is making its facilities and know-how available to meet the complex challenge of producing A-dopamine in an anaerobic environment, a rare technological breakthrough requiring highly specific production conditions similar to those already implemented by IDD-Xpert for anticancer projects from French and Swiss biotechs respectively. About the Parkinson’s disease Parkinson’s disease is the fastest-growing neurological disorder in the world, with a prevalence having doubled over the past 25 years. It affects 2.6 million individuals across the five major European markets, the United States, and Japan, with half of these patients being in the advanced stage of the disease. The Parkinson’s disease results from the progressive degeneration of dopaminergic neurons, leading to a dopamine deficiency that causes major motor disability, often accompanied by pain, cognitive-behavioral disorders, and autonomic dysfunction. In advanced disease stage, treatment options are restricted to few device-assisted therapies (DATs), which in practice are used in less than a third of the patients due to either their limited efficacy or their feared invasiveness or their level of discomfort holding a negative impact on patients’ daily lives. Intracerebroventricular (i.c.v.) dopamine infusion is expected to offer an attractive alternative to this limited therapeutic armamentarium and meet a pressing unmet need for effective care. About the “First Factory” Call for Projects Launched in 2022 as part of the France 2030 plan, this initiative—led by the French Directorate General for Enterprise (DGE), in collaboration with the General Secretariat for Investment and operated on behalf of the French State by Bpifrance—is aimed at innovative industrial start-ups and SMEs. Its goal is to accelerate the industrialization of strategic and innovative productions within France. The program is part of the broader effort by the French government to revive industrial sovereignty through the France 2030 Plan and the “Industrial Start-ups” strategy, which seeks to transform France’s research and entrepreneurial excellence into industrial and productive success stories. Innovative players are seen as key drivers of this reindustrialization, particularly in the development of next-generation technologies. About France 2030 ✔ Encompasses a dual ambition: to sustainably transform key sectors of the French economy (such as health, energy, automotive, aerospace, and space) through technological innovation, and position France not just as a player but as a global leader in shaping the world of tomorrow. From fundamental research to the emergence of new ideas and the production of novel goods or services, France 2030 supports the entire innovation lifecycle up to industrialization. ✔ Unprecedented in its scale: €54 billion will be invested to ensure that French companies, universities, and research organizations can successfully lead transitions in strategic sectors. The goal is to empower them to respond competitively to ecological and economic challenges and to foster the emergence of future champions in our fields of excellence. France 2030 is guided by two cross-cutting goals: dedicating 50% of its spending to decarbonizing the economy, and 50% to emerging players and innovation projects with no significant harm to the environment (in line with the “Do No Significant Harm” principle). ✔ A collaborative implementation: designed and deployed in close consultation with economic, academic, local, and European stakeholders to define its strategic directions and flagship actions. Project leaders are invited to submit applications through open, rigorous, and selective procedures to receive support from the French State. ✔ Led by the General Secretariat for Investment on behalf of the Prime Minister and implemented by the French Environment and Energy Management Agency (ADEME), the National Research Agency (ANR), Bpifrance, and the Banque des Territoires. More information: france2030.gouv.fr | Twitter/X: @SGPI_avenir About Bpifrance Bpifrance, the French Public Investment Bank, finances businesses at every stage of their development through loans, guarantees, and equity investments. It also supports companies with their innovation and international expansion projects. Bpifrance facilitates export activity through a wide range of solutions. Its services also include advisory support, a business university, networking opportunities, and acceleration programs tailored to startups, SMEs, and mid-sized companies (ETIs). With 50 regional offices, Bpifrance provides entrepreneurs with a single, close, and effective point of contact to help them meet their challenges. More information: www.bpifrance.fr – https://presse.bpifrance.fr Follow us on X (formerly Twitter): @BpifranceLeLab – @bpifrance – @BpifrancePresse and on LinkedIn – lelab.bpifrance.fr – www.bpifrance.fr Press contact: Florence Portejoie, FP2COM, 06 07 76 82 83, fportejoie@fp2com.fr Attachment InBrain_PR_PERCEPAR_VDEF_20250512

Post-hoc analysis of higher risk older adults showed substantial and sustained improvements in tardive dyskinesia symptoms with no new treatment-emergent adverse events of clinical concern SAN DIEGO, April 24, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of a post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrating the long-term safety profile and robust efficacy of INGREZZA® (valbenazine) capsules in adults aged 65 years and older with tardive dyskinesia (TD) in The Journal of Clinical Psychiatry. This represents the first and only published peer-reviewed analysis of a vesicular monoamine transporter 2 inhibitor for the treatment of TD in older adults (≥65 years), a group at higher risk for TD and associated consequences. Individuals aged 60 years and older may develop TD after as little as one month of exposure to antipsychotics and other dopamine receptor blocking agents. The involuntary movements of TD can also have a substantial impact on older adults, affecting their balance, gait, ability to swallow and respiratory conditions. The data from this post-hoc analysis show substantial and sustained improvements in TD symptoms in older adults, with no new treatment-emergent adverse events of clinical concern found when compared with younger adults (<65 years). "This analysis, the first and only of its kind in a peer-reviewed publication, addresses an important gap in research on this potentially vulnerable population," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "These data show that participants 65 years and older achieved clinically meaningful improvements in tardive dyskinesia symptoms within eight weeks of INGREZZA treatment, with substantial and sustained improvement up to 48 weeks, adding to the breadth of evidence suggesting INGREZZA is uniquely suitable for this patient population." The pooled post-hoc analysis included 304 participants across studies who received a once-daily dose of INGREZZA (40 mg or 80 mg) for up to 48 weeks. Of the total participants, 55 (18.1%) were 65 years and older. At Week 48, efficacy and safety outcomes were analyzed by dose (40 mg, 80 mg) and age (<65 years, ≥65 years). The efficacy of INGREZZA was assessed using mean changes from baseline in the Abnormal Involuntary Movement Scale (AIMS) total score, AIMS response thresholds (≥30% and ≥50% improvement from baseline) and response threshold for Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and Patient Global Impression of Change (PGIC), defined as a score ≤2 ("much improved" or "very much improved"). At baseline, participants in both age subgroups had a mean AIMS total score of approximately 12, consistent with moderate to severe severity in one or more body regions. The safety profile of INGREZZA was evaluated through adverse event monitoring and psychiatric symptom scales. Data from this analysis of participants ≥65 years in the KINECT 3 extension and KINECT 4 studies suggest substantial and sustained improvements in TD symptoms with INGREZZA treatment (all doses): Overall, psychiatric stability was maintained through 48 weeks of treatment and INGREZZA was generally well tolerated. The most common treatment-emergent adverse events reported from Weeks 8 to 48 included urinary tract infection and somnolence; each occurred in six of the 55 participants who were 65 years and older. There were no statistically significant differences between age groups (<65 versus ≥65) for most efficacy and safety outcomes at Week 48. About the KINECT® 3 Phase 3 Study KINECT 3 is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in which 234 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received six weeks of once-daily INGREZZA (40 mg or 80 mg capsules) or placebo (participants randomized to 80 mg started on 40 mg for one week). Subsequent to the completion of the six-week placebo-controlled dosing, participants receiving INGREZZA continued on their current dose and placebo participants were randomized to receive either once-daily 40 mg or once-daily 80 mg of INGREZZA, through Week 48 (42-week blinded treatment extension period; placebo participants randomized to 80 mg started on 40 mg for one week), followed by a four-week, drug-free washout. Dose reduction to 40 mg was allowed for participants who were unable to tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated. The study met its primary endpoint of change-from-baseline in AIMS at Week 6 in the 80 mg once-daily dosing group compared with placebo as assessed by expert central blinded video raters. The mean change from baseline to Week 6 in the AIMS rating was -3.2 for the 80 mg once-daily group as compared with -0.1 in the placebo group (P>0.0001). Sustained TD improvements were seen with INGREZZA 40 mg and 80 mg through Week 48. INGREZZA was generally well tolerated throughout 48 weeks of treatment. The most common adverse reactions (≥ 5% and twice the rate of placebo) during the six-week, double-blind, placebo-controlled phase was somnolence with the frequency of adverse events being similar among all treatment groups. Treatment-emergent adverse events were consistent with those of prior studies. There were no drug-drug interactions identified in participants who were utilizing a wide range of psychotropic and other concomitant medications, and participants generally remained psychiatrically stable throughout the study. About the KINECT® 4 Phase 3 Study KINECT 4 is a Phase 3, open-label study in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated. Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment-emergent adverse events that occurred in ≥5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant. About Tardive Dyskinesia Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, 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 proven 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 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 neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA 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 potential benefits to be derived from INGREZZA 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 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 annual report on Form 10-K for the year ended December 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0058 04/2025 SOURCE Neurocrine Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED