Lisdexamfetamine Dimesylate

Woburn, MA—February 10, 2026—Azurity Pharmaceuticals, Inc. announced that ARYNTA™ (lisdexamfetamine dimesylate) Oral Solution will be available mid-2026 for treating ADHD in adults and pediatric patients 6 years and older. Arynta, a ready-to-use lisdexamfetamine oral solution that may be stored at room temperature between 68°F to 77°F (20°C to 25°C),1 received FDA approval in June 2025. “Azurity Pharmaceuticals is proud to offer Arynta as an option for patients who need or prefer an oral liquid and are seeking flexibility in their treatment options,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. In pivotal Phase 3 clinical trials that evaluated the efficacy and safety of lisdexamfetamine across pediatric and adult patient populations, lisdexamfetamine demonstrated statistically significant efficacy for the core symptoms of hyperactive-impulsive and inattention in ADHD.1 As a prodrug of amphetamine, Arynta delivers reliable symptom control for up to 13 hours in children and up to 14 hours in adults, and its safety and tolerability profile is similar to that of other stimulant medication.1-5 Please read the full Prescribing Information, including Boxed Warning, and additional safety information at www.arynta/full-prescribing-information. Azurity Pharmaceuticals is committed to serving overlooked patients, including those who have difficulty swallowing capsules or prefer a liquid form. It is reported that approximately 70% of children and about 30% of adolescents refuse or have difficulty swallowing tablets or capsules.6 Certain patient populations are more impacted than others. For example, about 40% of children with autism also have ADHD and many children with autism struggle with food texture hypersensitivity, which can make taking medication in capsule and sprinkle form a challenge.7-10 Arynta helps to address this need as part of Azurity’s innovative dose-form solutions. IMPORTANT SAFETY INFORMATION ARYNTATM (lisdexamfetamine dimesylate) Oral Solution, CIIARYNTA is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Moderate to severe binge eating disorder (BED) in adults. Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. ARYNTA is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of ARYNTA for the treatment of obesity have not been established. WARNING: ABUSE, MISUSE, AND ADDICTION ARYNTA has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ARYNTA, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ARYNTA, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout ARYNTA treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)]. ADDITIONAL IMPORTANT SAFETY INFORMATION Do not take ARYNTA if you or your child are: Allergic to amphetamine products or any of the ingredients in ARYNTA. Taking, or have stopped taking in the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI). Being treated with the antibiotic linezolid or intravenous methylene blue. What are the possible side effects of ARYNTA? ARYNTA may cause serious side effects, including: Abuse, misuse, and addiction: ARYNTA has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ARYNTA, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ARYNTA or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with ARYNTA and will monitor you or your child during treatment. ARYNTA may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Your provider should check you or your child carefully for heart problems before starting treatment with ARYNTA. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Increased blood pressure and heart rate: Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ARYNTA. Mental (psychiatric) problems: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Slowing of growth (height and weight) in children: Children should have their height and weight checked often during treatment with ARYNTA. ARYNTA treatment may be stopped if your child is not growing or gaining weight as expected. Circulation problems in fingers and toes (Peripheral Vasculopathy, including Raynaud’s phenomenon): Signs and symptoms may include: fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Serotonin Syndrome: A potentially life-threatening problem called serotonin syndrome may happen when ARYNTA is taken with certain other medicines. Stop taking ARYNTA and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome: agitation fast heartbeat flushing seizures coma sweating loss of coordination confusion dizziness tremors, stiff muscles, or muscle twitching seeing or hearing things that are not real (hallucination) changes in blood pressure high body temperature (hyperthermia) nausea, vomiting, diarrhea New or worsening tics or worsening Tourette’s syndrome: Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with ARYNTA. Before taking ARYNTA, tell your doctor about all your medical conditions, including if you or your child: Have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart rhythm problems Have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression Have circulation problems in fingers and toes Have kidney problems Have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome Are pregnant or plan to become pregnant. ARYNTA may harm the unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ARYNTA. Are breastfeeding or plan to breastfeed. ARYNTA passes into breast milk. You should not breastfeed during treatment with ARYNTA. Talk to your healthcare provider about the best way to feed the baby during treatment with ARYNTA. Tell your healthcare provider about all the medicines that you or your child take, including: Prescription and over-the-counter medicines, vitamins, and herbal supplements. ARYNTA can affect the way other medicines work and other medicines may affect how ARYNTA works. Taking ARYNTA with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with ARYNTA. The most common side effects of ARYNTA: In children 6 to 17 years and adults with ADHD include decreased or loss of appetite, diarrhea, dry mouth, trouble sleeping, stomach pain, anxiety, weight loss, dizziness, irritability, nausea, and vomiting. In adults with BED include dry mouth, decreased appetite, constipation, anxiety, trouble sleeping, increased heart rate, and feeling restless. The Important Safety Information does not include all the information needed to use ARYNTA safely and effectively. Please see accompanying full Prescribing Information for ARYNTA. To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.ARYNTATM is a trademark of Azurity Pharmaceuticals, Inc. ©2025 Azurity Pharmaceuticals, Inc. PP-ARY-US-0003 References Arynta [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2025. Boellner SW, Stark JG, Krishnan S, Zhang Y. Pharmacokinetics of lisedexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: a single-dose, randomized, open-label, crossover study. Clin Ther. 2010;32(2):252-264 Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. J Psychopharmacol. 2009;23(4):419–427. Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol. 2009;23(4):410–418. Kaland ME, Klein-Schwartz W. Comparison of lisdexamfetamine and dextroamphetamine exposures reported to U.S. poison centers. Clin Toxicol (Phila). 2015;53(5):477–485. Polaha J, Dalton WT 3rd, Lancaster BM. Parental report of medication acceptance among youth: implications for everyday practice. South Med J. 2008;101(11):1106-1112. Houghton R, Ong RC, Bolognani F. Psychiatric comorbidities and use of psychotropic medications in people with autism spectrum disorder in the United States. Autism Res. 2017;10(12):2037–2047. American Academy of Child and Adolescent Psychiatry. ADHD in Youth With ASD: Parents’ Medication Guide. Published 2023. Accessed July 7, 2025. https://www.aacap.org/App_Themes/AACAP/docs/resource_centers/resources/med_guides/ADHDwithASD_Web.pdf Cermak SA, Curtin C, Bandini LG. Food selectivity and sensory sensitivity in children with autism spectrum disorders. J Am Diet Assoc. 2010;110(2):238–246. Cutler AJ, Mattingly GW. Beyond the pill: new medication delivery options for ADHD. CNS Spectr. 2017;22(6):463–474. About Azurity Pharmaceuticals: Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. Our medicines have benefited millions of people. For more information, visit www.azurity.com. Media Contact media@azurity.com AryntaTM is a trademark of Azurity Pharmaceuticals, Inc. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. ©2026 Azurity Pharmaceuticals, Inc. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. PP-ARY-6394-US-EN-v2 02/26

关注前途汇，获取海内外医药行业最新资讯 对接医药并购、新药研发和技术转让合作商机~ 对于拥有 240 年历史的武田而言， 2021-2025年是一个典型的防御期。期间消化夏尔（Shire） 并购、应对 Vyvanse 等产品的仿制药冲击。而在今年的JPM大会上，CEO Christophe Weber 定义2026 年为转折点，这源于对财务模型的理性预判。这家营收规模达 4.6 万亿日元（约 300 亿美元）的巨头，正试图通过 8 款核心创新资产，在 2030 年Entyvio 专利到期之前，构建一条主要由创新药驱动的高斜率增长曲线。 一、重新定义神经科的临床终点 在武田的后期管线中，Oveporexton (TAK861) 是毫无疑问的皇冠明珠。作为全球首个提交 NDA的口服食欲素受体 2（OX2R）激动剂，武田在发作性睡病1 型（NT1）赛道上抢占了先发优势。传统的神经科药物往往只能做到症状缓解，但 Oveporexton 的数据展现了功能性治愈的潜力： 清醒维持测试 (MWT)： 63% 的患者达到正常人范围。 爱泼沃斯嗜睡量表 (ESS)： 85%的患者回归正常水平。 猝倒控制： 中位数据显示，患者每周无猝倒天数高达 4.7 天。 【行业启示】 一旦 Oveporexton获批，它将建立极高的临床门槛，迫使后续的竞争者（如 Alkermes, Jazz 等）必须在头对头研究中证明更优的效力或安全性。武田赌对了靶点，更赌赢了成药性。 二、18个月内的发射窗口 武田正处于产品密集上市的前夜。未来 18 个月内的三连发，是检验其全球商业化团队执行力的关键战役： 1. Oveporexton (NT1,预计 2026 H2)： 这一资产的上市将直接验证武田在神经科学领域的统治力。 2. Rusfertide (真性红细胞增多症 PV, 预计2026 H2)： 铁调素（Hepcidin）模拟物。直击 PV 患者频繁放血的痛点，提供持久的红细胞压积控制。这是针对未满足需求的精准打击。 3. Zasocitinib (银屑病, 预计 2027 H1)： 高选择性 TYK2 抑制剂。通过优效的安全性（避免 JAK 类药物的脱靶毒性）和每日一次的便利性，重塑口服银屑病市场，并挑战百时美施贵宝（BMS）Sotyktu 的市场地位。 【行业启示】 这种密集的上市节奏，旨在快速拉升新产品营收占比，以对冲存量资产的自然衰减。对于投资者而言，关注重点应从管线预期转向具体的销售爬坡斜率。 三、Big 8与多模态 除了上述三款近期产品，武田还公布了8款数十亿美金级别的重磅资产。武田已经彻底摆脱了传统药企对小分子的路径依赖，展现出极强的多模态研发能力，什么技术能解决问题，就用什么技术。 siRNA： Fazirsiran (TAK999) 针对 AATD 肝病。这是武田与 Arrowhead 合作的结晶，证明了其在 RNAi 领域的布局能力。 ADC ： TAK921 (CLDN18.2 ADC)。尽管 CLDN18.2 赛道拥挤，但武田依然试图通过差异化的 Linker、Payload 技术在胃癌领域分一杯羹。 抗体与融合蛋白： Mezagitamab (CD38 抗体)： 拓展至 IgA 肾病和 ITP，挖掘自身免疫的蓝海。 Elritercept (配体陷阱技术)： 针对 MDS 贫血，挑战现有的治疗格局。 【行业启示】 这种多模态布局，显著降低了研发组合的系统性风险。武田不再押注于某一种单一技术平台的成功，而是通过技术堆栈的多元化，确保在 2030 年后 Entyvio 专利悬崖到来时，有足够的弹药接棒。 四、价值观的商业逻辑 在 JPM 这样的资本场合，谈论价值观似乎有些格格不入。但武田反复强调的武田主义（Takedaism）（患者 > 信任 > 声誉 > 业务），其实有一套严密的商业逻辑。 作为一家总部位于东京、全球研发中心位于波士顿（剑桥）的跨国企业，武田面临着极高的跨文化管理成本和合规风险。将信任置于业务之前，本质上是一种最高级别的风控策略。在监管日益严格、药价压力巨大的全球环境下，这种长期主义的信任资产，往往能转化为更稳健的市场准入和更低的法律风险成本。 结语： 武田在 2026 年展示的不仅仅是管线，更是一份后 LOE 时代的生存指南。如果说过去五年武田是在还债（消化并购、应对仿制药），那么从2026 年开始，武田正式进入了收割期。Oveporexton 能否如期引爆？Zasocitinib 能否抢下 TYK2 的王座？这将决定武田能否成功从一家管理衰退的企业，转型为一家由 FIC/BIC 创新驱动的增长型巨头。 对于行业观察者而言，武田的这一跃，值得期待。 【免责声明】 1. 非投资建议：本文内容仅为基于公开资料的行业研究与学术交流，不构成任何形式的投资建议或财务顾问意见。读者不应单纯依靠本文信息而取代自身的独立判断，应自主做出投资决策并自行承担风险。 2. 信息来源：文中涉及的数据、图表及财务信息均来源于公司财报、公告及公开新闻报道。我们力求信息准确可靠，但不对其完整性、准确性或及时性做出保证。 3. 前瞻性陈述：文中关于公司未来战略、业绩预测或行业趋势的表述属于前瞻性陈述，具有不确定性，实际结果可能与预测存在重大差异。 4. 利益冲突：作者与文中提及的公司无任何利益相关，文章撰写未受任何商业赞助或干预。 医药行业交流群 识别二维码加入医药行业交流群 关于前途汇 医药项目经纪服务： 公司搭建了覆盖全球 20000 余家机构的资源网络，包括科研院所、药企、投资机构等，通过线上线下会议、数据库匹配等方式，为医药企业提供精准的投融资、并购、技术转让（License in/out）等资源对接服务。 资源和人脉拓展桥梁： 公司每年组织5次以上行业线下交流大会，为医药企业、科研院所、投资机构搭建信息交流渠道，发掘商机，拓展人脉。目前累计召开会议超过100场，足迹遍布绝大部分一二线城市。 医药出海助推器： 我们积极组织国内企业参与国际交流，推动领先新药权益授权至海外市场，实现价值转化，并让国内优质的原料药与制剂惠及全球。同时，通过并购海外优质企业，帮助客户获取先进技术项目与国际销售渠道，助力中国医药企业家构建全球化视野。