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Tevogen Commends HHS for Addressing Long COVID, Emphasizes TVGN 489’s Potential Impact for 20 Million Americans

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Tevogen Bio (NASDAQ:TVGN) has acknowledged the U.S. Department of Health and Human Services' (HHS) initiative to address Long COVID through two focused roundtables. The company highlighted that approximately 20 million U.S. adults are affected by Long COVID, significantly impacting workforce participation and national productivity.

The company's investigational drug TVGN 489 has shown promising results in a Proof-of-Concept clinical trial. Tevogen is developing this therapy through its proprietary ExacTcell™ platform, which enables rapid development of genetically unmodified precision T cell therapies. The company aims to create accessible and affordable personalized therapeutics for Long COVID patients.

Tevogen Bio (NASDAQ:TVGN) ha riconosciuto l'iniziativa del Dipartimento della Salute e dei Servizi Umani degli Stati Uniti (HHS) per affrontare la Long COVID attraverso due tavole rotonde mirate. L'azienda ha sottolineato che circa 20 milioni di adulti statunitensi sono colpiti dalla Long COVID, con un impatto significativo sulla partecipazione al lavoro e sulla produttività nazionale.

Il farmaco in fase di sperimentazione TVGN 489 ha mostrato risultati promettenti in uno studio clinico di Proof-of-Concept. Tevogen sta sviluppando questa terapia tramite la sua piattaforma proprietaria ExacTcell™, che consente uno sviluppo rapido di terapie T cell a precisione non geneticamente modificate. L'azienda punta a creare terapie personalizzate accessibili e a basso costo per i pazienti con Long COVID.

Tevogen Bio (NASDAQ:TVGN) ha reconocido la iniciativa del Departamento de Salud y Servicios Humanos de Estados Unidos (HHS) para abordar el Long COVID a través de dos mesas redondas enfocadas. La compañía destacó que aproximadamente 20 millones de adultos estadounidenses están afectados por el Long COVID, lo que impacta significativamente la participación en la fuerza laboral y la productividad nacional.

El fármaco en investigación de la empresa, TVGN 489, ha mostrado resultados prometedores en un ensayo clínico de concepto. Tevogen está desarrollando esta terapia mediante su plataforma propietaria ExacTcell™, que permite el desarrollo rápido de terapias de células T de precisión sin modificaciones genéticas. La compañía busca crear terapias personalizadas, accesibles y asequibles para los pacientes con Long COVID.

Tevogen Bio (NASDAQ:TVGN)은 미국 보건복지부(HHS)의 Long COVID 해결을 위한 두 차례의 집중형 라운드테이블 이니셔티브를 인정했습니다. 회사는 약 2천만 명의 미국 성인이 Long COVID의 영향을 받고 있다고 강조했으며, 이는 노동력 참여도와 국가 생산성에 상당한 영향을 미칩니다.

회사의 연구약물 TVGN 489은 개념증명(Proof-of-Concept) 임상시험에서 유망한 결과를 보였습니다. Tevogen은 이 치료제를 자사의 독점 플랫폼 ExacTcell™을 통해 개발 중이며, 이는 유전자 변형 없이도 정확도 높은 T 세포 치료제를 빠르게 개발할 수 있게 해줍니다. 회사는 Long COVID 환자들을 위한 접근 가능하고 저렴한 개인 맞춤 치료제를 만들겠다는 목표를 가지고 있습니다.

Tevogen Bio (NASDAQ:TVGN) a reconnu l'initiative du Department of Health and Human Services (HHS) des États‑Unis pour aborder le Long COVID à travers deux tables rondes ciblées. La société a souligné que environ 20 millions d'adultes américains sont touchés par le Long COVID, impactant fortement la participation à la main-d'œuvre et la productivité nationale.

Le médicament expérimental de la société, TVGN 489, a montré des résultats prometteurs dans un essai clinique de preuve de concept. Tevogen développe ce traitement via sa plateforme propriétaire ExacTcell™, qui permet le développement rapide de thérapies à base de T cellules de précision non modifiées génétiquement. L'entreprise vise à créer des thérapies personnalisées, accessibles et abordables pour les patients atteints de Long COVID.

Tevogen Bio (NASDAQ:TVGN) hat die Initiative des US-Gesundheitsministeriums (HHS) zur Bewältigung von Long COVID durch zwei fokussierte Runden Tische anerkannt. Das Unternehmen hob hervor, dass etwa 20 Millionen US-Erwachsene von Long COVID betroffen sind, was die Arbeitsmarktbeteiligung und die nationale Produktivität erheblich beeinträchtigt.

Das experimentelle Arzneimittel TVGN 489 hat in einer Proof-of-Concept- klinischen Studie vielversprechende Ergebnisse gezeigt. Tevogen entwickelt diese Therapie über seine firmeneigene ExacTcell™-Plattform, die eine schnelle Entwicklung von genetisch nicht modifizierten Präzisions-T-Zelltherapien ermöglicht. Das Unternehmen will zugängliche und erschwingliche personalisierte Therapien für Long-COVID-Patienten schaffen.

Tevogen Bio (NASDAQ:TVGN) اعترفت بمبادرة وزارة الصحة والخدمات الإنسانية الأمريكية (HHS) لمعالجة مرض كوفيد الطويل من خلال جلستين مستديرتين مركّزتين. وأبرزت الشركة أن حوالي 20 مليون بالغ أمريكي متأثرون بالمرض، ما يؤثر بشكل كبير على المشاركة في سوق العمل والإنتاجية الوطنية.

دواء الشركة التجريبي TVGN 489 أظهر نتائج واعدة في تجربة سريرية لإثبات المفهوم. تقوم Tevogen بتطوير هذا العلاج من خلال منصتها المملوكة ExacTcell™، التي تتيح التطوير السريع لعلاجات خلايا T الدقيقة من دون تعديل جيني. تهدف الشركة إلى إنشاء علاجات شخصية متاحة وبأسعار معقولة للمرضى المصابين بكوفيد الطويل.

Tevogen Bio (NASDAQ:TVGN) 已确认美国卫生与公共服务部(HHS)就通过两次聚焦性圆桌会议应对长期新冠的倡议。公司指出,约有2000万名美国成年人受到长期新冠的影响,对劳动力参与度和国家生产力产生显著影响。

公司的在研药物 TVGN 489 在概念验证型临床试验中显示出有希望的结果。Tevogen 正通过其自主平台 ExacTcell™ 开发这项治疗,该平台能够快速开发无需基因修改的精准T细胞治疗。公司目标是为长期新冠患者创造可及且负担得起的个性化治疗方案。

Positive
  • TVGN 489 demonstrated promising results in Proof-of-Concept clinical trial
  • Company's ExacTcell platform enables rapid and scalable T cell therapy development
  • Targeting large market opportunity with 20 million U.S. adults affected by Long COVID
Negative
  • Additional capital needed to execute business plan
  • Limited operating history as stated in risk factors
  • Requires regulatory approval with uncertain outcome

WARREN, N.J., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today expressed its gratitude to the U.S. Department of Health and Human Services (HHS), Secretary Robert F. Kennedy, Jr., and the Trump Administration for convening two Long COVID roundtables focused on patient experiences and research.

Long COVID continues to affect millions of Americans; according to Yale Medicine, approximately 20 million adults in the U.S. are living with Long COVID, a condition that not only impacts individual health but also carries major economic consequences by keeping people out of the workforce and contributing to significant productivity losses across the nation.

Tevogen believes its investigational drug, TVGN 489, which has demonstrated promising results in a Proof-of-Concept clinical trial, could potentially play an important role in addressing this ongoing public health crisis.

Ryan Saadi, M.D., M.P.H., Chief Executive Officer of Tevogen stated, “I have always prioritized SARS-CoV-2 and its lasting consequences. Long COVID has disrupted the lives of millions of patients and families, and I am highly optimistic that our investigational therapy, TVGN 489, could make a meaningful difference in restoring health and hope for these individuals.”

Curtis L. Patton, Ph.D., Professor Emeritus of Epidemiology, Yale School of Public Health, and member of Tevogen Board of Directors, added, “The Long COVID crisis is not only a medical challenge but also a societal one, with far-reaching impacts on economic productivity and quality of life. I commend the leadership of HHS in addressing this pressing issue, and I believe innovative therapies like TVGN 489 may hold the key to meaningful progress for patients who have been suffering far too long.”

Tevogen remains committed to developing accessible and affordable personalized therapeutics through its proprietary ExacTcell™ platform, which enables the rapid and scalable development of genetically unmodified precision T cell therapies.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications

T: 1 877 TEVOGEN, Ext 701

Communications@Tevogen.com


FAQ

What is Tevogen's TVGN 489 drug candidate for Long COVID treatment?

TVGN 489 is Tevogen's investigational therapy that has shown promising results in a Proof-of-Concept clinical trial, aimed at treating Long COVID patients.

How many Americans are affected by Long COVID according to Tevogen's announcement?

According to Yale Medicine, cited in Tevogen's announcement, approximately 20 million adults in the United States are currently living with Long COVID.

What is Tevogen's ExacTcell platform technology?

ExacTcell™ is Tevogen's proprietary platform that enables the rapid and scalable development of genetically unmodified precision T cell therapies.

Who is the CEO of Tevogen Bio (TVGN)?

Ryan Saadi, M.D., M.P.H. is the Chief Executive Officer of Tevogen Bio.

What are the main challenges Tevogen faces in developing TVGN 489?

Tevogen faces challenges including the need for additional capital, regulatory approval requirements, and risks associated with clinical development and commercialization of new therapeutics.
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