REDWOOD CITY, Calif. - Biomea Fusion, Inc. (NASDAQ:BMEA), a biopharmaceutical company in the clinical stage, announced today that its leading product candidate for treating diabetes and certain cancers, BMF-219, has been granted an International Nonproprietary Name (INN) and a United States Adopted Name (USAN). The World Health Organization has approved "icovamenib" as the INN, and the USAN Council has adopted the same name for BMF-219.
The newly named icovamenib, which indicates its function as a menin inhibitor, is part of Biomea Fusion's efforts to develop oral covalent small molecules. These molecules form permanent bonds with target proteins and are believed to offer advantages like increased selectivity and a more durable response compared to non-covalent drugs.
Biomea Fusion plans to use the name icovamenib in future presentations, publications, and public statements as it advances the clinical development of the product candidate. The company's proprietary FUSION™ System is being utilized to discover and design a pipeline of next-generation covalent-binding small molecule medicines.
The naming approvals by WHO's INN Expert Group and the USAN Council, which involve the American Medical Association, the United States Pharmacopeial Convention, and the American Pharmacists Association, are significant steps in the standardization and safety process of medication names.
Biomea Fusion's focus is on creating treatments for diabetes, obesity, and genetically defined cancers, aiming to significantly impact patient care. The company has ongoing and planned clinical trials, including COVALENT-111 and COVALENT-112, although specific data availability and trial progress have not been detailed in the announcement.
The information in this article is based on a press release statement from Biomea Fusion, Inc. and is intended to provide an overview of the recent developments regarding the naming of BMF-219 as icovamenib. The company has made forward-looking statements about the potential of icovamenib and its research and development plans, which are subject to the safe harbor provisions of the Securities Act and the Exchange Act. Biomea Fusion has acknowledged that there are risks and uncertainties that could affect the actual results of their product candidates and development programs.
In other recent news, Biomea Fusion Inc. received a Buy rating from EF Hutton, which set a price target of $128.00 based on the potential of Biomea Fusion's BMF-219, currently in early-stage trials for diabetes treatment. The U.S. Food and Drug Administration (FDA) lifted the clinical hold on BMF-219 studies, allowing the company to continue Phase I/II and Phase II clinical trials. This development led to several analyst firms adjusting their stance on the company: Piper Sandler reaffirmed its Overweight rating, while Scotiabank and H.C. Wainwright raised their price targets and Truist Securities upgraded the company's stock from Hold to Buy.
Additionally, Biomea Fusion announced the formation of its Global Scientific Advisory Board, composed of international experts in diabetes and beta cell science, to guide the development of BMF-219. Furthermore, the company is expected to release preclinical safety and efficacy data for a new obesity drug candidate. These recent developments have prompted positive responses from various analyst firms, including Scotiabank, H.C. Wainwright, and Truist Securities, all expressing confidence in the drug's potential and eagerly waiting for the forthcoming Phase 2b data readout, expected by the end of 2024.
InvestingPro Insights
Biomea Fusion's recent announcement of the INN and USAN approval for icovamenib comes at a time when the company is experiencing significant market attention. According to InvestingPro data, Biomea Fusion has seen a remarkable 131.15% price total return over the past three months, indicating strong investor interest in the company's potential.
Despite this positive momentum, it's important to note that Biomea Fusion is currently not profitable, with an operating income of -$148.4 million over the last twelve months as of Q2 2023. This aligns with an InvestingPro Tip that suggests analysts do not anticipate the company will be profitable this year, which is common for clinical-stage biopharmaceutical companies investing heavily in research and development.
However, Biomea Fusion's financial position shows some strengths. An InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, potentially providing the financial flexibility needed to continue its clinical trials and development of icovamenib.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Biomea Fusion, providing a more comprehensive view of the company's financial health and market position.
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