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Biomea Fusion Announces Approval of “icovamenib” as International Nonproprietary Name for BMF-219

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Biomea Fusion (Nasdaq: BMEA) announced that the World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for its lead product candidate BMF-219. The United States Adopted Name Council has also adopted this name as the United States Adopted Name (USAN). Icovamenib is an oral covalent menin inhibitor in clinical development, investigating its impact on insulin-producing beta cells.

The suffix '-menib' denotes a menin inhibitor. INNs and USANs are unique, globally recognized names for pharmaceutical drugs or active ingredients, ensuring safety, consistency, and logic in medication naming. Biomea will use "icovamenib" in future presentations, publications, and public statements as it advances the clinical development of this product candidate.

Biomea Fusion (Nasdaq: BMEA) ha annunciato che l'Organizzazione Mondiale della Sanità (OMS) ha approvato "icovamenib" come Nome Non Proprietario Internazionale (INN) per il suo principale candidato terapeutico BMF-219. Il Consiglio dei Nomi Adottati degli Stati Uniti ha anche adottato questo nome come Nome Adottato degli Stati Uniti (USAN). Icovamenib è un inibitore covalente della menina in fase di sviluppo clinico, che ne indaga l'impatto sulle cellule beta produttrici di insulina.

Il suffisso '-menib' indica un inibitore della menina. Gli INN e gli USAN sono nomi unici e riconosciuti a livello globale per farmaci o principi attivi, garantendo sicurezza, coerenza e logica nella denominazione dei farmaci. Biomea utilizzerà "icovamenib" nelle future presentazioni, pubblicazioni e dichiarazioni pubbliche mentre avanza nello sviluppo clinico di questo candidato terapeutico.

Biomea Fusion (Nasdaq: BMEA) anunció que la Organización Mundial de la Salud (OMS) ha aprobado "icovamenib" como el Nombre No Propietario Internacional (INN) para su principal candidato a producto BMF-219. El Consejo de Nombres Adoptados de Estados Unidos también ha adoptado este nombre como Nombre Adoptado de Estados Unidos (USAN). Icovamenib es un inhibidor covalente de menin en desarrollo clínico, que investiga su impacto en las células beta productoras de insulina.

El sufijo '-menib' denota un inhibidor de menin. Los INN y USAN son nombres únicos y reconocidos a nivel mundial para fármacos o ingredientes activos, asegurando seguridad, consistencia y lógica en la denominación de medicamentos. Biomea utilizará "icovamenib" en futuras presentaciones, publicaciones y declaraciones públicas mientras avanza en el desarrollo clínico de este candidato a producto.

Biomea Fusion (Nasdaq: BMEA)은 세계 보건 기구(WHO)가 자사의 주요 후보 제품인 BMF-219의 국제 비독점 명칭(INN)으로 "icovamenib"를 승인했다고 발표했습니다. 미국 채택 명칭 위원회(USAN)도 이 이름을 미국 채택 명칭(USAN)으로 채택했습니다. Icovamenib는 구강 공유 메닌 억제제로 임상 개발 중이며, 인슐린 생성 베타 세포에 미치는 영향을 조사하고 있습니다.

접미사 '-menib'는 메닌 억제제를 나타냅니다. INN과 USAN은 약물이나 활성 성분에 대한 고유하고 전 세계적으로 인정된 이름으로, 약물 명명에서 안전성, 일관성 및 논리를 보장합니다. Biomea는 이 제품 후보의 임상 개발을 진행함에 따라 향후 발표, 출판물 및 공공 성명에서 "icovamenib"를 사용할 것입니다.

Biomea Fusion (Nasdaq: BMEA) a annoncé que l'Organisation mondiale de la santé (OMS) a approuvé "icovamenib" comme Nom Non Propriétaire International (INN) pour son principal candidat de produit BMF-219. Le Conseil des noms adoptés des États-Unis a également adopté ce nom comme Système de Nom des États-Unis (USAN). Icovamenib est un inhibiteur covalent de la menine en développement clinique, qui enquête sur son impact sur les cellules bêta productrices d'insuline.

Le suffixe '-menib' indique un inhibiteur de menine. Les INN et USAN sont des noms uniques et reconnus mondialement pour les médicaments ou les principes actifs, garantissant sécurité, cohérence et logique dans la dénomination des médicaments. Biomea utilisera "icovamenib" dans les futures présentations, publications et déclarations publiques alors qu'elle fait progresser le développement clinique de ce candidat produit.

Biomea Fusion (Nasdaq: BMEA) gab bekannt, dass die Weltgesundheitsorganisation (WHO) "icovamenib" als International Nonproprietary Name (INN) für ihren Hauptproduktkandidaten BMF-219 genehmigt hat. Der United States Adopted Name Council hat diesen Namen ebenfalls als United States Adopted Name (USAN) angenommen. Icovamenib ist ein oraler kovalenter Menin-Inhibitor, der sich in der klinischen Entwicklung befindet und seine Auswirkungen auf insulinproduzierende Beta-Zellen untersucht.

Die Endung '-menib' weist auf einen Menin-Inhibitor hin. INNs und USANs sind einzigartige, weltweit anerkannte Namen für pharmazeutische Arzneimittel oder Wirkstoffe, die Sicherheit, Konsistenz und Logik bei der Benennung von Medikamenten gewährleisten. Biomea wird "icovamenib" in zukünftigen Präsentationen, Veröffentlichungen und öffentlichen Aussagen verwenden, während das Unternehmen die klinische Entwicklung dieses Produktkandidaten vorantreibt.

Positive
  • WHO approval of "icovamenib" as the INN for BMF-219
  • USAN Council adoption of "icovamenib" as the USAN for BMF-219
  • Potential application in treating diabetes and obesity
Negative
  • None.

Icovamenib is an oral covalent menin inhibitor in clinical development to investigate its impact on the function of insulin-producing beta cells

REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that the World Health Organization (WHO) has approved “icovamenib” as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, and that the United States Adopted Name Council has adopted “icovamenib” as the United States Adopted Name (USAN) for BMF-219. The suffix ‘-menib’ stands for menin inhibitor.

An International Nonproprietary Name (INN) is a unique, globally recognized name for a pharmaceutical drug or active ingredient. A United States Adopted Name (USAN) is a nonproprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names of US medications; the USAN Council, is co-sponsored by the American Medical Association, the United States Pharmacopeial Convention, and the American Pharmacists Association. WHO’s INN Expert Group and the USAN Council approve simple, informative and unique nonproprietary names, also known as generic names. Biomea will use “icovamenib” in upcoming presentations, publications and public statements as the company advances the clinical development of the product candidate.

To learn more about icovamenib and its potential impact in diabetes please visit our website at https://biomeafusion.com/diabetes-obesity.

About Biomea Fusion
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.

Visit us at biomeafusion.com and follow us on LinkedIn, X, and Facebook.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib (formerly known as BMF-219), the potential of icovamenib as a treatment for type 2 and type 1 diabetes, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-111 and COVALENT 112, the availability of data from our clinical trials and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.


FAQ

What is the new International Nonproprietary Name (INN) for Biomea Fusion's BMF-219?

The World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for Biomea Fusion's lead product candidate BMF-219.

What does icovamenib (BMF-219) target in Biomea Fusion's clinical development?

Icovamenib (BMF-219) is an oral covalent menin inhibitor in clinical development to investigate its impact on the function of insulin-producing beta cells.

What is the significance of the '-menib' suffix in icovamenib for Biomea Fusion (BMEA)?

The suffix '-menib' in icovamenib stands for menin inhibitor, indicating the mechanism of action of Biomea Fusion's (BMEA) lead product candidate.

How will Biomea Fusion (BMEA) use the name icovamenib in the future?

Biomea Fusion (BMEA) will use "icovamenib" in upcoming presentations, publications, and public statements as the company advances the clinical development of the product candidate.

Biomea Fusion, Inc.

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