DiagnaMed Granted FDA Orphan Drug Designation for Molecular Hydrogen to Treat Amyotrophic Lateral Sclerosis
DiagnaMed Holdings (OTCQB: DGNMF) has received FDA Orphan Drug Designation for molecular hydrogen in treating Amyotrophic Lateral Sclerosis (ALS). This designation supports the development of treatments for this rare neuromuscular disease that affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases annually.
Molecular hydrogen, known for its antioxidant and anti-inflammatory properties, has shown promising results in preclinical studies for mitigating oxidative stress and inflammation in ALS progression. The designation provides key benefits including tax credits for clinical trials, FDA fee exemptions, and potential seven-year market exclusivity upon approval.
Additionally, DiagnaMed has entered a non-binding letter of intent with Revive Therapeutics dated February 28, 2025, to acquire full rights to DiagnaMed's intellectual property related to molecular hydrogen for ALS. The acquisition is expected to close by March 31, 2025, subject to due diligence and definitive agreement.
DiagnaMed Holdings (OTCQB: DGNMF) ha ricevuto la Designazione di Farmaco Orfano dalla FDA per l'idrogeno molecolare nel trattamento della Sclerosi Laterale Amiotrofica (SLA). Questa designazione supporta lo sviluppo di trattamenti per questa rara malattia neuromuscolare che colpisce circa 50.000 persone negli Stati Uniti e in Europa, con oltre 5.000 nuovi casi all'anno.
L'idrogeno molecolare, noto per le sue proprietà antiossidanti e antinfiammatorie, ha mostrato risultati promettenti negli studi preclinici per mitigare lo stress ossidativo e l'infiammazione nella progressione della SLA. La designazione offre vantaggi chiave, tra cui crediti d'imposta per le sperimentazioni cliniche, esenzioni dalle tasse FDA e una potenziale esclusiva di mercato di sette anni dopo l'approvazione.
Inoltre, DiagnaMed ha firmato una lettera di intenti non vincolante con Revive Therapeutics datata 28 febbraio 2025, per acquisire i diritti completi sulla proprietà intellettuale di DiagnaMed relativa all'idrogeno molecolare per la SLA. Si prevede che l'acquisizione si concluda entro il 31 marzo 2025, soggetta a due diligence e accordo definitivo.
DiagnaMed Holdings (OTCQB: DGNMF) ha recibido la Designación de Medicamento Huérfano por parte de la FDA para el hidrógeno molecular en el tratamiento de la
El hidrógeno molecular, conocido por sus propiedades antioxidantes y antiinflamatorias, ha mostrado resultados prometedores en estudios preclínicos para mitigar el estrés oxidativo y la inflamación en la progresión de la ELA. La designación proporciona beneficios clave, incluyendo créditos fiscales para ensayos clínicos, exenciones de tarifas de la FDA y una posible exclusividad de mercado de siete años tras la aprobación.
Además, DiagnaMed ha firmado una carta de intención no vinculante con Revive Therapeutics con fecha del 28 de febrero de 2025, para adquirir los derechos completos sobre la propiedad intelectual de DiagnaMed relacionada con el hidrógeno molecular para la ELA. Se espera que la adquisición se cierre antes del 31 de marzo de 2025, sujeta a la debida diligencia y un acuerdo definitivo.
DiagnaMed Holdings (OTCQB: DGNMF)는 FDA의 희귀의약품 지정을 받았습니다. 이는 근위축성 측삭 경화증 (ALS) 치료를 위한 분자 수소에 대한 것입니다. 이 지정은 미국과 유럽에서 약 50,000명의 환자에게 영향을 미치는 이 희귀 신경근육 질환의 치료 개발을 지원합니다. 매년 5,000건 이상의 새로운 사례가 발생하고 있습니다.
항산화 및 항염증 특성으로 알려진 분자 수소는 ALS 진행에서 산화 스트레스와 염증을 완화하는 데 있어 전임상 연구에서 유망한 결과를 보여주었습니다. 이 지정은 임상 시험에 대한 세액 공제, FDA 수수료 면제 및 승인 시 7년의 시장 독점 가능성 등 주요 혜택을 제공합니다.
또한, DiagnaMed는 Revive Therapeutics와 2025년 2월 28일자 비구속 의향서에 서명하여 ALS에 대한 분자 수소와 관련된 DiagnaMed의 지적 재산권을 전면 인수하기로 했습니다. 인수는 2025년 3월 31일까지 마감될 것으로 예상되며, 실사 및 최종 계약에 따라 달라질 수 있습니다.
DiagnaMed Holdings (OTCQB: DGNMF) a reçu la Désignation de Médicament Orphelin de la FDA pour l'hydrogène moléculaire dans le traitement de la Sclérose Latérale Amyotrophique (SLA). Cette désignation soutient le développement de traitements pour cette maladie neuromusculaire rare qui touche environ 50 000 personnes aux États-Unis et en Europe, avec plus de 5 000 nouveaux cas chaque année.
L'hydrogène moléculaire, connu pour ses propriétés antioxydantes et anti-inflammatoires, a montré des résultats prometteurs dans des études précliniques pour atténuer le stress oxydatif et l'inflammation dans la progression de la SLA. La désignation offre des avantages clés, notamment des crédits d'impôt pour les essais cliniques, des exonérations de frais de la FDA et une exclusivité de marché potentielle de sept ans après approbation.
De plus, DiagnaMed a signé une lettre d'intention non contraignante avec Revive Therapeutics datée du 28 février 2025, pour acquérir les droits complets sur la propriété intellectuelle de DiagnaMed relative à l'hydrogène moléculaire pour la SLA. L'acquisition devrait être finalisée d'ici le 31 mars 2025, sous réserve de la diligence raisonnable et d'un accord définitif.
DiagnaMed Holdings (OTCQB: DGNMF) hat von der FDA die Orphan Drug Designation für molekularen Wasserstoff zur Behandlung von amyotropher Lateralsklerose (ALS) erhalten. Diese Auszeichnung unterstützt die Entwicklung von Behandlungen für diese seltene neuromuskuläre Erkrankung, die etwa 50.000 Menschen in den USA und Europa betrifft, mit jährlich über 5.000 neuen Fällen.
Molekularer Wasserstoff, der für seine antioxidativen und entzündungshemmenden Eigenschaften bekannt ist, hat in präklinischen Studien vielversprechende Ergebnisse gezeigt, um oxidativen Stress und Entzündungen im Verlauf der ALS zu mindern. Die Auszeichnung bietet wichtige Vorteile, darunter Steuergutschriften für klinische Studien, Befreiungen von FDA-Gebühren und potenzielle siebenjährige Marktexklusivität nach der Genehmigung.
Darüber hinaus hat DiagnaMed ein nicht bindendes Absichtsschreiben mit Revive Therapeutics vom 28. Februar 2025 unterzeichnet, um die vollständigen Rechte an DiagnaMeds geistigem Eigentum in Bezug auf molekularen Wasserstoff für ALS zu erwerben. Der Abschluss der Übernahme wird bis zum 31. März 2025 erwartet, vorbehaltlich einer Due Diligence und einer endgültigen Vereinbarung.
- FDA Orphan Drug Designation received for ALS treatment
- 7-year market exclusivity potential upon approval
- Tax credits and FDA fee exemptions granted
- Large addressable market of 50,000 ALS patients
- Strategic partnership with Revive Therapeutics pending
- Treatment still in preclinical stage
- LOI with Revive is non-binding
- No guaranteed timeline for FDA approval
Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) ("DiagnaMed", "DMED", or the "Company"), a leading provider of cutting-edge technology solutions for the hydrogen and life sciences industries, today announced in a significant advancement for rare disease research, the Company has been granted Orphan Drug Designation (ODD) for molecular hydrogen in the treatment of amyotrophic lateral sclerosis (ALS) by the U.S. Food and Drug Administration (FDA). This designation underscores the potential of molecular hydrogen as a novel therapeutic option for ALS patients and highlights ongoing efforts to address unmet medical needs in rare disease communities.
ALS is a progressive neuromuscular disease that attacks nerve cells responsible for controlling voluntary muscle movement, leading to paralysis and, ultimately, respiratory failure, and has a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. With limited treatment options available, the FDA's recognition of molecular hydrogen as an orphan drug offers hope to patients and families impacted by this debilitating illness.
Molecular hydrogen, a small molecule with antioxidant and anti-inflammatory properties, has shown early promise in preclinical studies for its ability to mitigate oxidative stress and inflammation-key factors implicated in ALS progression. The FDA's decision paves the way for DiagnaMed to accelerate its discovery and development programs with molecular hydrogen.
One of DiagnaMed's strategic initiatives regarding hydrogen is to unlock the medical potential of molecular hydrogen for neurodegenerative diseases and brain health conditions (press release). The Company's commercialization strategy involves partnering with specialty pharmaceutical companies to fund the development of its medical programs involving molecular hydrogen.
Letter of Intent with Revive Therapeutics Ltd (CSE: RVV) (OTCQB: RVVTF) ("Revive")
DiagnaMed and Revive have entered into a non-binding letter of intent (LOI), dated February 28, 2025, with Revive to acquire the full rights to DiagnaMed's intellectual property (the "Acquired Assets") pertaining to molecular hydrogen for ALS (the "Acquisition"). The final terms of the Acquisition will be agreed to by the parties after the completion of due diligence by Revive. The Acquisition is expected to close on or before March 31, 2025, subject to customary closing conditions, including but not limited to, the negotiation and execution of a definitive agreement.
Fabio Chianelli, Chairman and CEO of DiagnaMed, commented:
"Receiving orphan drug designation from the FDA is a significant milestone for DiagnaMed and validates the promise of molecular hydrogen as a potential treatment for ALS. We are excited to partner with Revive Therapeutics to advance this program and meet the urgent needs of the ALS community."
The Orphan Drug Designation provides DiagnaMed with key incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon approval. These benefits are designed to encourage the development of therapies for rare diseases that might otherwise lack sufficient commercial interest.
About DiagnaMed
DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) delivers innovative technology solutions for the cleantech and life sciences industries, with a focus on hydrogen production and AI-driven drug discovery and diagnostics. Visit DiagnaMed.com.
For more information, please contact:
Fabio Chianelli
Chairman and CEO
DiagnaMed Holdings Corp.
Tel: 416-800-2684
Email: info@diagnamed.com
Website: www.diagnamed.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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FAQ
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