Aligos Therapeutics Receives USAN Council Approval for pevifoscorvir sodium as Nonproprietary Name for ALG-000184
Aligos Therapeutics (Nasdaq: ALGS) announced that the USAN Council has adopted pevifoscorvir sodium as the nonproprietary (generic) name for ALG-000184, an investigational therapy for chronic hepatitis B virus (HBV) infection. The name is intended to provide consistent identification and support international recognition and transparency.
The company said the name, shortened to “pevy,” is the first generic name assigned to a compound at Aligos and comes as the program advances through the ongoing Phase 2 B-Supreme study. The announcement highlights a regulatory-naming milestone rather than clinical readouts or approvals.
Aligos Therapeutics (Nasdaq: ALGS) ha annunciato che il USAN Council ha adottato pevifoscorvir sodium come nome non proprietario (generico) per ALG-000184, una terapia sperimentale per l'infezione cronica da virus dell'epatite B (HBV). Il nome è volto a fornire un'identificazione coerente e a sostenere il riconoscimento internazionale e la trasparenza.
L'azienda ha affermato che il nome, abbreviato in “pevy”, è il primo nome generico assegnato a un composto da Aligos e arriva mentre il programma procede nel Phase 2 B-Supreme study in corso. L'annuncio evidenzia una tappa di denominazione normativa piuttosto che risultati clinici o approvazioni.
Aligos Therapeutics (Nasdaq: ALGS) anunció que el USAN Council ha adoptado pevifoscorvir sodium como el nombre genérico (no propietario) para ALG-000184, una terapia en investigación para la infección crónica por el virus de la hepatitis B (HBV). El nombre pretende proporcionar una identificación coherente y apoyar el reconocimiento internacional y la transparencia.
La empresa dijo que el nombre, abreviado como “pevy,” es el primer nombre genérico asignado a un compuesto en Aligos y llega a medida que el programa avanza en el ensayo Phase 2 B-Supreme en curso. El anuncio destaca un hito regulatorio de nomenclatura en lugar de resultados clínicos o aprobaciones.
Aligos Therapeutics(나스닥: ALGS)가 미국 USAN 위원회가 pevifoscorvir sodium를 ALG-000184에 대한 비독점적(제네릭) 이름으로 채택했다고 발표했습니다. 이는 만성 B형 간염 바이러스(HBV) 감염에 대한 연구 치료제입니다. 이 이름은 일관된 식별을 제공하고 국제적 인 인식과 투명성을 뒷받침하기 위한 것입니다.
회사에 따르면 이 이름은 약칭으로 “pevy”이며 Aligos에서 화합물에 부여된 최초의 제네릭 이름이며, 프로그램이 현재 진행 중인 2상 B-Supreme 연구를 통해 진행됨에 따라 발표되었습니다. 이번 발표는 임상 결과나 허가가 아닌 규제상의 명명 이정표를 강조합니다.
Aligos Therapeutics (Nasdaq: ALGS) a annoncé que le conseil USAN a adopté pevifoscorvir sodium comme nom non propriétaire (générique) pour ALG-000184, une thérapie expérimentale pour l'infection chronique par le virus de l'hépatite B (HBV). Le nom vise à assurer une identification cohérente et à soutenir la reconnaissance internationale et la transparence.
L'entreprise a déclaré que le nom, abrégé en « pevy », est le premier nom générique attribué à un composé chez Aligos et intervient alors que le programme progresse dans l'étude Phase 2 B-Supreme en cours. L'annonce met en évidence une étape de dénomination réglementaire plutôt que des résultats cliniques ou des approbations.
Aligos Therapeutics (Nasdaq: ALGS) gab bekannt, dass der USAN-Rat pevifoscorvir sodium als den nicht proprietären (generischen) Namen für ALG-000184 angenommen hat, eine experimentelle Therapie gegen chronische Hepatitis-B-Virus (HBV)-Infektion. Der Name soll eine konsistente Identifikation gewährleisten und internationale Anerkennung und Transparenz unterstützen.
Das Unternehmen sagte, dass der Name, verkürzt zu „pevy“, der erste generische Name ist, der einem Bestandteil bei Aligos zugewiesen wurde, und kommt, während das Programm in die laufende Phase-2-Studie B-Supreme voranschreitet. Die Ankündigung betont einen regulatorischen Namensmeilenstein statt klinischer Ergebnisse oder Zulassungen.
Aligos Therapeutics (Nasdaq: ALGS) أعلنت أن مجلس USAN اعتمد pevifoscorvir sodium كاسم غير مملوك/عام لـ ALG-000184، وهو علاج تجريبي لعدوى فيروس التهاب الكبد الوبائي B المزمن (HBV). يهدف الاسم إلى توفير تعريف متسق ودعم الاعتراف الدولي والشفافية.
وقالت الشركة إن الاسم، المختصر إلى “pevy”، هو أول اسم عام يُمنح لجزيء في Aligos ويأتي مع تقدم البرنامج خلال الدراسة الجارية Phase 2 B-Supreme. يبرز الإعلان التحول التنظيمي في التسمية بدلاً من القراءات السريرية أو الموافقات.
Aligos Therapeutics（纳斯达克股票代码：ALGS）宣布，美国药用命名委员会已将pevifoscorvir sodium确认为ALG-000184的非专有名（通用名），这是一种用于慢性乙型肝炎病毒（HBV）感染的研究治疗药物。该名称旨在提供一致的识别，并支持国际认可与透明度。
公司表示，该名称简称为“pevy”，是 Aligos 具备的第一个分配给化合物的通用名，随着该计划在进行中的Phase 2 B-Supreme 研究中前进而发布。公告强调的是监管命名里程碑，而非临床结果或批准。
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SOUTH SAN FRANCISCO, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the United States Adopted Names (USAN) Council has adopted pevifoscorvir sodium as the nonproprietary (generic) name for ALG-000184, under investigation for the treatment of chronic hepatitis B virus (HBV) infection.
The USAN, consisting of members from the Food and Drug Administration (FDA), American Medical Association (AMA), United States Pharmacopeia (USP) and the American Pharmacists Association (APhA), is responsible for developing simple, informative and unique nonproprietary (generic) drug names.
“The adoption of pevifoscorvir sodium, or pevy, marks the first generic name for a compound at Aligos,” stated Lawrence Blatt, PhD, MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “As we continue to progress our Phase 2 B-Supreme study, we look forward to adopting this new name. This milestone showcases our continued innovation in the liver and viral disease space and reinforces our commitment to improving patient outcomes.”
Generic drug names like pevifoscorvir sodium ensure consistent identification. Standardized naming also supports international recognition and transparency across markets.
About pevifoscorvir sodium
Pevifoscorvir sodium (formerly known as ALG-000184) was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. Pevifoscorvir sodium is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B virus (HBV) infection. Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1 studies, pevifoscorvir sodium 300mg QD x ≤96 weeks ± entecavir (ETV) and pevifoscorvir sodium monotherapy have demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Pevifoscorvir sodium has a regulatory path, as acknowledged by the FDA, EMA, and NMPA (China), for subsequent studies utilizing the chronic suppressive pathway. Phase 1 96-week dosing of pevifoscorvir sodium has been completed with the final and post-treatment follow up data expected at the American Association for the Study of Liver Disease’s The Liver Meeting® in 2025. The Phase 2 B-SUPREME study initiated in August 2025, with interim data projected in 2026, and topline data anticipated in 2027.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2025 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
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FAQ
What is pevifoscorvir sodium and how does it relate to ALGS (Aligos Therapeutics)?
Does the USAN adoption of pevifoscorvir sodium mean ALG-000184 is FDA approved?
What stage of development is ALG-000184 (pevifoscorvir sodium) currently in?
Will the USAN name pevifoscorvir sodium affect ALGS stock (Nasdaq: ALGS) immediately?
How does a USAN adoption like pevifoscorvir sodium help patients and clinicians?
