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NEW YORK, NY / ACCESS Newswire / May 19, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based therapies for stress-related neuropsychiatric disorders, today announced two strategic engagements to support the advancement of its lead candidate, PT00114. The Company has engaged Floyd Regulatory Strategic Consulting, led by regulatory affairs veteran Dr. Eric Floyd, Ph.D., MBA, as Regulatory Affairs Advisor, and DanforthHealth, a premier life science operational consulting firm, to establish institutional-grade operational processes and infrastructure. Together, these engagements reflect Protagenic's deliberate, lean operating model concentrating resources and expertise on PT00114's Phase 2 advancement while positioning the Company for long-term value creation for patients and shareholders. Dr. Floyd brings more than 25 years of senior regulatory leadership experience in the pharmaceutical and biopharmaceutical industries. As U.S. Head of Regulatory Affairs at Lundbeck, he led strategic regulatory activities supporting the U.S. approvals of Abilify Maintena ® (aripiprazole extended-release injectable suspension), Trintellix ® (vortioxetine), and Rexulti ® (brexpiprazole) - three landmark CNS products spanning schizophrenia and major depressive disorder. Dr. Floyd has also held senior regulatory roles at Novartis, Cephalon, and Axovant Sciences, and most recently served as Global Head of Regulatory Affairs at Neurogene, Inc. He serves as adjunct faculty in Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. As Regulatory Affairs Advisor, Dr. Floyd will lead Protagenic's regulatory strategy for PT00114, including IND maintenance, pre-Phase 2 FDA meeting preparation and Phase 2 submission planning. "Eric's regulatory track record in CNS and his leadership on three of the most important CNS approvals of the past decade is exceptional," said Bill Nichols Jr., President of Protagenic Therapeutics . "And his deep knowledge of FDA's expectations in neuropsychiatric drug development is precisely what PT00114 requires as we advance toward Phase 2." "PT00114's mechanism of action targeting the TCAP pathway, and the clean Phase 1 safety data the program has generated, create a strong foundation for a rigorous Phase 2 program," said Dr. Eric Floyd, Ph.D., MBA, Founder and Principal of Floyd Regulatory Strategic Consulting . "I have spent my career moving CNS therapies from concept to patients and I look forward to bringing that experience to bear for Protagenic at this pivotal moment." Protagenic has also engaged the finance & human resources consulting arm of Danforth Health to establish streamlined operational processes and infrastructure aligned with the Company's current stage and strategic priorities. Danforth has served more than 1,800 life science companies across business operations, development, and commercialization, and brings a flexible, scalable team of cross-functional biotech professionals. Danforth's extensive strategic relationships across the life science ecosystem - spanning investors, clinical service providers, and investment banks - provide Protagenic with access to a network very well uniquely suited to accelerate its development trajectory. "Danforth has built an unmatched capability serving exactly the kind of company Protagenic is today," said Mr. Nichols. "Their flexible, scalable model allows us to build institutional-grade operations - investor-ready financial processes, disciplined governance, and strategic access to the broader life science ecosystem - without the overhead of a large internal infrastructure. That is precisely the model Protagenic needs as we advance PT00114 toward Phase 2." These engagements build on recent operational and clinical milestones at Protagenic, including the completion of the Phytanix separation in March 2026, which strengthened the Company's balance sheet by removing more than $6.3 million in liabilities and more than $1 million in annualized costs. Coupled with its completed PT00114 Phase 1 multiple-dose safety and tolerability study, these milestones position Protagenic to advance PT00114 into Phase 2 enrollment in 2026 with a focused team, clean capital structure and experienced advisory partners. About PT00114 PT00114 is Protagenic's lead clinical asset - a first-in-class investigational neuropeptide targeting the TCAP pathway for the treatment of stress-related neuropsychiatric disorders, including anxiety, PTSD, and treatment-resistant depression. In December 2025, the program reported positive Phase 1 multiple-dose safety and tolerability data, with no serious adverse events observed across dose levels. Protagenic plans to advance PT00114 into Phase 2 clinical studies in 2026. About Protagenic Therapeutics, Inc. Protagenic Therapeutics, Inc. (OTCQB: PTIX) is a clinical-stage biopharmaceutical company dedicated to developing breakthrough peptide-based treatments for stress-related neuropsychiatric disorders. The Company is headquartered in New York, NY. About Floyd Regulatory Strategic Consulting Floyd Regulatory Strategic Consulting is a specialized regulatory affairs advisory firm founded and led by Dr. Eric Floyd, Ph.D., MBA. With more than 25 years of experience in pharmaceutical and biopharmaceutical regulatory affairs, Dr. Floyd provides strategic regulatory guidance to clinical-stage companies across CNS, oncology, and rare disease therapeutic areas. The firm's expertise spans IND strategy, FDA engagement and meeting management, clinical protocol regulatory review, NDA/BLA planning, and submission management. About Danforth Health Danforth Health is a unified platform purpose-built to empower life science innovation. By integrating the capabilities of best-in-class affiliates, Danforth Health provides tailored, cross-functional support across finance and human resources, investor and public relations, discovery and development, regulatory and clinical, commercial and marketing, market research and analytics, and market access and value. The model is built for flexibility, scalability, and impact - serving life science companies at any stage and helping them move faster, smarter, and more efficiently to achieve transformative outcomes for patients. Headquartered in Waltham, Massachusetts, Danforth Health has partnered with more than 1,800 life science companies around the world. Learn more at . Trademark Notice Abilify Maintena ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Trintellix ® is a registered trademark of H. Lundbeck A/S. Rexulti ® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Danforth Advisors ™ is a trademark of Danforth Advisors, LLC. All other trademarks are the property of their respective owners. For more information, visit 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, including but not limited to statements regarding the anticipated role and contribution of Dr. Floyd, the planned timing of Phase 2 enrollment for PT00114, and the therapeutic potential of PT00114. These statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Protagenic Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Investor & Media Contact: Protagenic Therapeutics, Inc. | info@protagenic.com | SOURCE: Protagenic Therapeutics, Inc. 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注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 5月21日，据NMPA官网公示，齐鲁制药提交的两款4类仿制药——西尼莫德片与阿贝西利片正式获批上市，并视同通过一致性评价。其中，西尼莫德片为国内首家获批，打破诺华原研的独家市场格局；阿贝西利片为国内第2家获批，齐鲁仿制药管线再添重磅品种。 截图来源：NMPA官网 01 3亿+美元畅销品种，两家药企同日拿下国内首仿 西尼莫德由诺华研发，是一款新一代选择性1-磷酸鞘氨醇（S1P）受体调节剂，它能够与淋巴细胞中的S1P1亚型受体相结合，防止它们进入多发性硬化症（MS）患者的中枢神经系统（CNS），从而达到抑制炎症的效果。 市场表现方面，据摩熵医药数据显示，原研西尼莫德销售额稳步攀升，2022年全球销售额达3.57亿美元，2023年再度增长至3.9亿美元，市场竞争力强劲。 国内市场布局上，该药品的多发性硬化症药2020年进入中国市场，随后进入国家医保谈判目录。摩熵医药数据显示，2023年西尼莫德片在国内全终端医院市场销售额超5700万元；2025年销售额有所回落，全年销售额超2700万元。 截图来源：全终端医院销售数据库（查数据.找摩熵） 作为高价值罕见病用药，西尼莫德片的仿制布局备受行业关注，国内仅有两家药企提交申报。其中，湖南科伦制药于2023年2月首家提交该品种4类仿制上市申请，目前仍处于审评审批阶段；齐鲁制药紧随其后，于2024年1月4日提交的仿制上市申请获国家药监局受理，历经两年多，科伦和齐鲁于2026年5月21日同日成功获批，两家药企同日斩获国内首家+首仿。 截图来源：中国药品审评数据库（查数据.找摩熵） 02 8亿+大品种，齐鲁制药国内第2家获批 阿贝西利片是礼来开发的全球首款用于治疗早期乳腺癌的周期蛋白依赖性激酶4/6(CDK4/6)抑制剂，2018年全球销售额仅为2.55亿美元，2025年超过57亿美元。礼来的阿贝西利片最早于2020年获批进入中国市场，用于早期乳腺癌辅助治疗；2021年获批新适应症，用于治疗晚期或转移性乳腺癌。该药已纳入国家医保乙类目录。摩熵医药数据显示，该品种近年来在全终端医院市场销售额呈逐年上涨态势，2023年销售额达7.5亿元，2024年销售额近8亿元，2025年销售额超8亿元，同比增长达11.80%。 截图来源：全终端医院销售数据库（查数据.找摩熵） 仿制药申报方面，目前国内有山东百诺医药、青峰医药、齐鲁制药3家企业的阿贝西利片以仿制4类报产，其中青峰医药首家申报并顺利获批，拿下国内首仿+首家过评。此次齐鲁制药是国内第2家获批该品种的药企。  截图来源：过评药品汇总数据库（查数据.找摩熵） 03 齐鲁制药10款仿制药获批、3款为国内首仿 截至目前，2026年以来齐鲁制药（含子公司）已有10款仿制药获批上市，且全部视同通过一致性评价。其中，甲磺酸贝舒地尔片、布瑞哌唑口崩片、西尼莫德片3款品种斩获国内首仿。 截图来源：过评药品汇总数据库（查数据.找摩熵） 本次西尼莫德片和阿贝西利片获批，充分彰显了齐鲁制药在高端仿制药、罕见病药物、肿瘤靶向药领域的强劲研发实力与成熟产业化能力。 结语 随着西尼莫德片正式上市，国内多发性硬化患者迎来优质、平价的国产替代新选择，有效缓解原研药价格偏高、供给单一的问题，助力完善罕见病用药保障体系。同时，齐鲁制药8亿级肿瘤大品种阿贝西利片的顺利获批，也将丰富国产乳腺癌靶向用药选择，加速抗肿瘤药物国产化替代，持续夯实企业在高端仿制药领域的核心竞争力。 END 本文为原创文章，转载请留言获取授权 近期热门资源获取 司美格鲁肽2025年第二季度市场回顾2026.4.15 司美格鲁肽2025年第一季度市场回顾2026.4.8 2026年中国实体瘤流行病学趋势及热门靶点药物市场表现洞察2026.4.1 2023H2-2024H1中国药品分析报告-202504 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询最新报告 识别下方二维码领取 联系我们，体验摩熵医药更多专业服务 会议 合作 媒体 合作 数据库 咨询 数据 定制 报告 定制 点击阅读原文，申请摩熵医药企业版免费试用！