Methylphenidate Hydrochloride

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company’s lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review. A Key Regulatory Milestone Under the 505(b)(2) Pathway This marks a major regulatory inflection point for Cingulate and for the CTx-1301 program. CTx-1301 is being reviewed under the FDA’s 505(b)(2) regulatory pathway, which allows sponsors to reference existing data on previously approved active ingredients while demonstrating novel clinical benefit through a differentiated delivery mechanism. For Cingulate, this pathway offers the opportunity to leverage the extensive safety and efficacy data of dexmethylphenidate—an established and well-characterized stimulant—while enabling CTx-1301 to demonstrate rapid onset of effect and entire active-day duration through its proprietary multi-core PTR™ technology. The NDA submission follows completion of adult and pediatric Phase 3 trials, completion of all FDA-requested studies, and a positive pre-NDA meeting in April 2025 confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages for review. The FDA’s acceptance validates that Cingulate’s application meets the Agency’s standards for completeness and marks the beginning of the formal review period. Clinical Results Support Differentiated Profile In Phase 3 clinical trials, CTx-1301 improved ADHD signs and symptoms across multiple metrics in adult and pediatric patients (ages 6 years and older). Effect size measurements were large throughout the day, demonstrating that CTx-1301 provides a rapid onset of effect and sustained efficacy into the afternoon and evening, which may address long-standing gaps in ADHD management. Key findings include: Adult dose-optimization study: Achieved clinically meaningful improvements on the Permanent Product Measure of Performance (PERMP) and Adult ADHD Investigator Symptom Rating Scale (AISRS). Pediatric fixed-dose study: Demonstrated dose-dependent improvements on the ADHD rating scale 5 (ADHD-RS-5), Clinical Global Impression–Improvement (CGI-I), and Clinical Global Impression–Severity (CGI-S) scales. Safety and tolerability: No serious treatment-emergent adverse events were reported across studies, and the tolerability profile was consistent with that of other long-acting methylphenidate products. Management Commentary “FDA acceptance of our NDA marks a defining milestone for Cingulate,” said Cingulate Executive Chairman Jay Roberts. “CTx-1301 was engineered to address the practical shortcomings of today’s stimulant therapies—multiple daily dosing, midday rebound, and adherence challenges—through a single, once-daily tablet. This milestone affirms the robustness of our clinical and regulatory strategy, and positions Cingulate to transition from a development-stage to a commercial-stage company in 2026, pending FDA approval of CTx-1301.” Matt Brams, MD, Chief Medical Officer, added, “The acceptance of our NDA reflects the FDA’s recognition of the completeness of our submission and the strong body of evidence supporting CTx-1301’s efficacy, safety, and patient-centric design. Our adult and pediatric studies consistently demonstrated rapid symptom relief, sustained performance and the flexibility of dosing with or without food—attributes that we believe will resonate strongly with both physicians and patients.” Launch Readiness With the NDA now accepted, the FDA will conduct its full review of CTx-1301’s efficacy, safety, and overall risk–benefit profile. In parallel, Cingulate continues advancing key commercial readiness activities to ensure timely launch preparedness following potential approval. Through its exclusive manufacturing partnership with Bend Bio Sciences, Cingulate has completed process transfer and scale-up production using commercial-grade equipment, providing early validation and ensuring a reliable supply chain in preparation for launch. On the commercial front, Cingulate’s partnership with Indegene delivers an integrated, AI-driven omnichannel platform that combines advanced analytics with targeted field engagement to optimize prescriber reach, payer access, and patient support. Early payer research indicates strong formulary receptivity for once-daily CTx-1301, underscoring the product’s alignment with key clinical and adherence priorities in ADHD care. About Attention-Deficit/Hyperactivity Disorder (ADHD) ADHD is a chronic neurodevelopmental disorder affecting an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults. The condition is characterized by inattention, hyperactivity, and impulsivity that impair academic, professional, and social functioning. Stimulant medications remain the gold-standard therapy; however, most currently available extended-release formulations require multiple doses per day and often fail to provide consistent coverage across the entire active day. About CTx-1301 CTx-1301 (dexmethylphenidate) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway. About Cingulate Inc. Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve patient outcomes in conditions characterized by burdensome daily dosing and suboptimal therapeutic coverage. Cingulate’s lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in Kansas City, Kansas. For more information, visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities, the potential approval and commercialization of CTx-1301 and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Investor & Media Contact Thomas Dalton, Vice President, Corporate Communications Cingulate Inc. Email: tdalton@cingulate.com | Phone: (913) 942-2301

9月15日，爱科百发再次向港交所主板递交上市申请书，二度冲刺港股。 爱科百发是一家专做呼吸儿药的公司，创始人邬征曾经担任罗氏中国生物部及病毒部负责人，并主导开发了抗病毒产品齐瑞索韦。2013年，邬征回国创业，成立爱科百发，并在2014年花大价钱从罗氏引进了齐瑞索韦的全球开发和商业化独家权益。 邬征的野心很大，想复刻抗病毒龙头吉利德的成功。成立至今，爱科百发获得了多轮融资，2022年6月，爱科百发完成最新一轮1.9亿元融资，投后估值46.9亿元。但从几次上市失败的经历来看，企业经营并不如愿。此次爱科百发闯港披露的招股说明书显示，公司实际经营情况没有太大改善。 过去几年，公司光研发不卖货陷入巨亏。根据招股书显示，2020-2024年及今年上半年，爱科百发已累计亏损超10亿元，手中尚无一个商业化产品。进展最快的核心产品齐瑞索韦和“聪明药”AK0901虽已进入上市申请阶段，但最快也要明年才有可能获批上市。 但此次爱科百发是不得不上市了：不闯港，爱科百发可能“活不下去”了。截至2025年6月30日，公司持有的现金及现金等价物仅9674万元，还有6个产品要大笔烧钱。这家估值近50亿元的创新药企，很可能倒在“回血”前夜。 科学家自立门户 要做“第二个吉利德”？ 邬征在抗病毒领域有很深的资历，齐瑞索韦系邬征在罗氏工作期间共同发明。2013年，罗氏内部对呼吸道合胞病毒治疗的战略定位发生变动，切割了对齐瑞索韦的研发精力，成了公司的“弃药”。 邬征曾在访谈中提到：从全球市场角度出发，罗氏认为RSV市场相对比较小，同时这又是一款儿童药，不愿意持续投资。 2013年，邬征回国成立爱科百发，紧接着就不惜花费接近1亿美元，才拿到了齐瑞索韦的全球权益。 邬征的理想是将爱科百发打造成抗病毒领域的“第二个吉利德”。他的野心不是没有依据，关于RNA类疾病的探索在全球医药界都是个大命题，合胞病毒是其中比较棘手的一个，近两年才被纳入跨国药企的研发视野。比如辉瑞曾试图切入合胞病毒疫苗，和GSK等知名企业瓜分市场，拯救业绩颓势。 目前，关于呼吸道合胞病毒的治疗，几乎所有管线都聚焦在疫苗上，齐瑞索韦是全球唯一能靶向RSV治疗的产品。 近几年，RSV治疗药物市场长得飞快。据招股书，2024年RSV治疗药物市场规模才为3000万美元，但到2026年，市场规模就会达到8.19亿美元，2035年更是会高达86亿美元。显然，罗氏错过了这一大蛋糕，爱科百发也有潜力成为“第二个吉利德”。 国内开发RSV治疗药物的企业也不多，据爱科百发的招股说明书，同行里只有旺山旺水的产品步入临床：儿童适应症进展至II/III期临床；成人用药仅尚处I期临床。 核心品种前景堪忧 焦虑市场补充第二增长曲线？ 爱科百发想要迈过上市门槛，可能先要解决自己产品的问题。2022年12月，齐瑞索韦的首次申报上市获受理，但去年2月，上市申请宣告失败，至今爱科百发也并未披露失败原因。 有业内人士表示，临床试验尤其涉及儿童临床试验，研究方法难度更大，数据要求也更严格。 成为“第二个吉利德”并不是那么容易的。今年8月，爱科百发再次向国家药监局提交齐瑞索韦的上市申请，用于治疗1-24个月婴儿的呼吸道合胞病毒感染。在招股说明书中，公司承诺该药将于明年上市。但经历过受挫，齐瑞索韦的商业化风险敞口也将不可避免的加大。 倒是爱科百发手里的另一款在研药物吸引了资本市场的注意，那就是“聪明药”AK0901。 AK0901指的是丝右哌甲酯右哌甲酯复方胶囊，是一款针对多动症患者的Best-in-Class创新复方制剂。该药曾于2021年3月在美国获批上市，是FDA近20年来首款批准的新一代哌甲酯类药物。2021年12月，爱科百发与Commave Therapeutics达成一项总金额为1.06亿美元的授权合作，获得了AK0901在大中华区的独家开发、生产及商业化权利。 多动症其实是个很大的治疗市场。爱科百发招股说明书称，到2035年中国的多动症药物规模将达到131亿元。多动症治疗药物的目标就是提升孩子的注意力和学习效率，常被家长称为“聪明药”。市面上早已有相关产品获批，立方制药、西安杨森、立优加等公司都有布局，但经常传出医院缺货的消息。 目前爱科百发的管线中，也就是AK0901最有希望快速获批回血了。这可能是这次爱科百发提交港股IPO的最大底气。 由于现在没有产品上市，爱科百发亏损不可避免。过去五年，公司累计亏损超过10亿元，2025年上半年更是亏损1.04亿元。研发是最大的支出项目，截至目前，爱科百发开发了6条候选药物管线，齐瑞索韦、AK0901算是其中进展最快的。其他AK0610、AK3280、AK0705、AK0406最快也才到临床III期的早期阶段。 招股书显示，AK3280是一款治疗特发性肺纤维化的产品，目前处于II期概念验证（PoC）后的临床阶段，公司预计2027年才能完成III期试验；AK0610是预防性单抗药物，治疗RSV感染，目前处于II期PoC阶段，有望与齐瑞索韦形成协同效应；还有慢性阻塞性肺疾病（COPD）治疗药物AK0705和流行性感冒治疗药物AK0406，处在早期临床阶段。 招股书显示，仅今年上半年，爱科百发研发就花掉了8000多万元。要知道，公司全部的现金及现金等价物也才9674万元。 如果ipo不顺，按照这个“烧钱”速度，爱科百发很难维持到今年年底。 撰稿 | 苗苗 编辑｜江芸 贾亭 运营 | 廿十三 插图 | 视觉中国 声明：健识局原创内容，未经许可请勿转载 内容如有问题，请邮件联系： jianshiju@boyamedia.com 商务咨询：13288688512