STOCK TITAN

Alpha Tau Announces Receipt of Radioactive Material License for its New Hampshire Manufacturing Facility, Advancing Towards Commercial Readiness

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags

Alpha Tau (Nasdaq: DRTS) received a radioactive material license from the State of New Hampshire Radiological Health Section for the first phase of its commercial-scale manufacturing facility in Hudson, New Hampshire.

The standalone building exceeds 14,000 rentable square feet and the first-phase nameplate capacity is approximately 400,000 Alpha DaRT sources for local use. The license allows the company to introduce thorium generators, equip the plant, and proceed with verification and validation steps aimed at producing Alpha DaRT treatments during 2026. Alpha DaRT is under evaluation in multiple clinical trials across several tumor types, including skin, head & neck, pancreas, lung, prostate, and brain.

Alpha Tau (Nasdaq: DRTS) ha ricevuto una licenza per materiale radioattivo dalla Sezione Salute Radiologica dello Stato del New Hampshire per la prima fase del suo impianto di produzione su scala commerciale a Hudson, New Hampshire.

L'edificio indipendente supera 14.000 metri quadrati affittabili e la capacità nominale della prima fase è di circa 400.000 sorgenti Alpha DaRT per uso locale. La licenza permette all'azienda di introdurre generatori di torio, attrezzare lo stabilimento e procedere con le fasi di verifica e convalida volte a produrre trattamenti Alpha DaRT nel 2026. Alpha DaRT è oggetto di valutazione in numerosi studi clinici su diversi tipi di tumore, tra cui pelle, testa e collo, pancreas, polmone, prostata e cervello.

Alpha Tau (Nasdaq: DRTS) recibió una licencia de material radiactivo por parte de la Sección de Salud Radiológica del Estado de New Hampshire para la primera fase de su instalación de fabricación a escala comercial en Hudson, New Hampshire.

El edificio independiente supera 14,000 pies cuadrados rentables y la capacidad nominal de la primera fase es aproximadamente 400,000 fuentes Alpha DaRT para uso local. La licencia permite a la empresa introducir generadores de torio, equipar la planta y avanzar con las etapas de verificación y validación orientadas a producir tratamientos Alpha DaRT durante 2026. Alpha DaRT está siendo evaluado en varios ensayos clínicos en múltiples tipos de tumores, incluidos piel, cabeza y cuello, páncreas, pulmón, próstata y cerebro.

Alpha Tau (나스닥: DRTS)는 뉴햄프셔 주 방사선 보건 부서의 방사선 건강 부문으로부터 Hudson, New Hampshire에 위치한 1단계 상용 규모 제조 시설에 대한 방사성 물질 라이선스를 받았습니다.

독립적인 건물은 14,000 임대 가능 평방피트를 능가하며 1단계의 표기 용량은 지역 사용을 위한 대략 400,000 Alpha DaRT 소스입니다. 이 라이선스는 회사가 토륨 발전기를 도입하고 공장을 설비하며 2026년에 Alpha DaRT 치료를 생산하기 위한 검증 및 확인 단계를 진행할 수 있도록 허용합니다. Alpha DaRT는 피부, 두경부, 췌장, 폐, 전립선 및 뇌를 포함한 여러 종양 유형에서 여러 임상 시험으로 평가 중입니다.

Alpha Tau (NASDAQ : DRTS) a reçu une licence de matériel radioactif de la section Santé Radiologique de l'État du New Hampshire pour la première phase de son usine de fabrication à l'échelle commerciale à Hudson, New Hampshire.

Le bâtiment indépendant dépasse 14 000 pieds carrés locatifs et la capacité nominale de la première phase est d'environ 400 000 sources Alpha DaRT pour une utilisation locale. La licence permet à l'entreprise d'introduire des générateurs de thorium, d'équiper l'usine et de procéder aux étapes de vérification et de validation visant à produire des traitements Alpha DaRT d'ici 2026. Alpha DaRT est évalué dans plusieurs essais cliniques couvrant plusieurs types de tumeurs, notamment la peau, la tête et le cou, le pancréas, les poumons, la prostate et le cerveau.

Alpha Tau (Nasdaq: DRTS) erhielt eine Lizenz für radioaktives Material von der Abteilung Radiologische Gesundheit des Staates New Hampshire für die erste Phase seiner kommerziellen Fertigungsanlage in Hudson, New Hampshire.

Das eigenständige Gebäude übersteigt 14.000 vermietbare Quadratfuß und die First-Phase-Nennkapazität beträgt ungefähr 400.000 Alpha DaRT-Quellen für den lokalen Gebrauch. Die Lizenz erlaubt dem Unternehmen, Thorium-Generatoren einzuführen, die Anlage auszustatten und Verifikations- und Validierungsschritte durchzuführen, die darauf abzielen, Alpha DaRT-Behandlungen im 2026 zu produzieren. Alpha DaRT wird in mehreren klinischen Studien über verschiedene Tumortypen evaluiert, darunter Haut, Kopf- und Halsbereich, Bauchspeicheldrüse, Lunge, Prostata und Gehirn.

Alpha Tau (بورصة ناسداك: DRTS) حصلت على ترخيص مادة مشعة من قسم الصحة الإشعاعية في ولاية نيو هامشيرى للمرحلة الأولى من منشأة التصنيع على نطاق تجاري في هادسون، نيو هامشيرى.

المبنى المستقل يتجاوز 14,000 قدم مربع قابل للإيجار وتبلغ قدرة المرحلة الأولى نحو 400,000 مصدر Alpha DaRT للاستخدام المحلي. يسمح الترخيص للشركة بإدخال مولدات الثوريوم، وتجهيز المصنع، والمضي قدمًا في خطوات التحقق والتحقق (الاعتماد) الموجهة لإنتاج علاجات Alpha DaRT خلال 2026. Alpha DaRT قيد التقييم في عدة تجارب إكلينيكية عبر أنواع أورام متعددة، بما في ذلك الجلد، الرأس والرقبة، البنكرياس، الرئة، البروستاتا والدماغ.

Alpha Tau(纳斯达克:DRTS) 已从新罕布什尔州放射卫生科获得一个用于其位于新罕布什尔州哈德森的商业规模制造工厂第一阶段的放射性材料许可

独立建筑面积超过14,000 可租赁平方英尺,第一阶段的铭牌容量约为400,000 Alpha DaRT 源,供本地使用。该许可允许公司引进铀铀? 这里要说的是铀? 它应为钍发电机:发电机,装备工厂,并进行面向在2026年生产 Alpha DaRT 治疗的验证与确认阶段。Alpha DaRT 正在多个临床试验中评估,涉及皮肤、头颈、胰腺、肺、前列腺和大脑等多种肿瘤类型。

Positive
  • Received radioactive material license from New Hampshire
  • First-phase facility >14,000 rentable square feet
  • Nameplate capacity ~400,000 Alpha DaRT sources
  • Target to begin manufacturing Alpha DaRT in 2026
Negative
  • Production timing contingent on verification, validation and assumptions
  • Capacity figure subject to operational and clinical assumptions
  • License is state-level (New Hampshire) and limited to this facility

Insights

Receipt of a state radioactive material license enables commercial build-out and targeted production start in 2026.

Alpha Tau obtained a radioactive material license from the State of New Hampshire following completion of phase one construction of its Hudson facility, clearing a formal regulatory hurdle needed to introduce radioactive material and install thorium generators. The stated nameplate capacity for phase one is approximately 400,000 Alpha DaRT sources, which, if realized, supplies local clinical use and supports initial commercial throughput.

The near-term operational path depends on equipment installation, verification and validation activities, and successful safe introduction of thorium generators—each is an explicit precondition mentioned for commencing production. These steps carry execution and regulatory-compliance risk; delays in commissioning, additional inspections, or operational qualification could shift timelines beyond the company’s target.

Watch for completion of equipment installation and formal verification/validation milestones, any further regulatory filings or inspections, and announcements confirming first manufactured Alpha DaRT treatments in 2026. The license date Oct. 21, 2025 frames a clear near-term horizon for operational updates and hiring or capacity disclosures tied to the Hudson facility.

Receipt of critical license marks significant milestone for first commercial-scale manufacturing facility for Alpha DaRT®, the innovative alpha-radiation cancer therapy designed for potent and conformal tumor irradiation -

- License paves way for introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing in 2026 -

JERUSALEM, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® announced today that it has secured a radioactive material license from the State of New Hampshire Bureau of Public Health Protection, Radiological Health Section, following completion of the first phase of construction of its commercial-scale manufacturing facility in Hudson, New Hampshire.

In October 2023, the Company entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in Hudson, New Hampshire, for an Alpha DaRT manufacturing facility to be constructed in multiple phases. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

“This is a very exciting operational milestone for Alpha Tau as we continue to prepare for future commercial operations,” stated Uzi Sofer, CEO of Alpha Tau. “I want to thank our dedicated operations and engineering teams who have spent countless hours ensuring that our facility is built to the highest standards, our partners at A&M Construction, and the officials from the New Hampshire Department of Health and Human Services involved in reviewing and approving our license. We also appreciate the support of New Hampshire’s Division of Economic Development and are excited to create more jobs in the state.”

“With our radioactive material license in hand for our plant’s first phase, we can proceed to equipping the facility, verification and validation, and introducing thorium generators, aiming to produce Alpha DaRT treatments in the facility during the course of 2026,” Sofer concluded.

Alpha DaRT is currently being evaluated in multiple clinical trials for the treatment of a broad range of cancers, including tumors of the skin, head & neck, pancreas, lung, prostate and brain.

About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT®
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “expect,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to our NH facility and future production and our ability to commercialize, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on Form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release.

Investor Relations Contact:
IR@alphatau.com


FAQ

What did Alpha Tau (DRTS) announce on October 21, 2025 about its New Hampshire facility?

Alpha Tau announced it secured a radioactive material license for its Hudson, New Hampshire manufacturing facility and plans to equip the plant for production.

How large is the Alpha Tau Hudson facility and what is its initial capacity for Alpha DaRT sources?

The standalone building exceeds 14,000 rentable square feet with a first-phase nameplate capacity of approximately 400,000 Alpha DaRT sources for local use.

When does Alpha Tau (DRTS) expect to start producing Alpha DaRT treatments at the Hudson plant?

The company is aiming to produce Alpha DaRT treatments at the facility during the course of 2026, pending equipment, verification, and validation.

What regulatory approval did Alpha Tau (DRTS) obtain for the Hudson manufacturing site?

Alpha Tau obtained a radioactive material license from the State of New Hampshire Bureau of Public Health Protection, Radiological Health Section.

Will the New Hampshire license allow Alpha Tau to introduce radioactive sources at the plant?

Yes; the license permits the company to introduce thorium generators and proceed with equipping, verification, and validation steps.
Alpha Tau Medical Ltd

NASDAQ:DRTS

DRTS Rankings

DRTS Latest News

DRTS Latest SEC Filings

DRTS Stock Data

340.17M
57.16M
32.79%
2.28%
0.11%
Biotechnology
Healthcare
Link
Israel
Jerusalem