Bomedemstat

The US FDA has approved Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), marking the first new approval in this indication in nearly three decades. PharmaEssentia USA Corporation, a Burlington, Massachusetts-based subsidiary of Taiwan-headquartered PharmaEssentia Corporation (TWSE: 6446), received the decision, which expands Besremi's existing label — the drug has been commercially available for polycythemia vera (PV) since 2021. The label does not specify genotype or prior-treatment requirements, allowing use in cytoreductive therapy-naive adults despite the pivotal SURPASS-ET trial having enrolled patients with inadequate response or intolerance to hydroxyurea. Besremi is a mono-pegylated, long-acting recombinant interferon alfa-2b administered subcutaneously. Its novel monopegylation technology extends half-life, enabling less frequent dosing. Unlike cytoreductive agents such as hydroxyurea or anagrelide — which primarily reduce platelet counts — ropeginterferon alfa-2b targets disease-driving clonal progenitor cells in the bone marrow via the JAK-STAT signaling pathway, with the potential to reduce JAK2 V617F mutant allele burden over time, the company said. The approval was based on the global Phase III SURPASS-ET trial (NCT04285086), a multicenter, open-label, randomized, active-controlled study. Published in Lancet Haematology in November 2025, the trial demonstrated superior durable response rates for Besremi versus anagrelide, with reduced thromboembolic events over 12 months of treatment in adults with ET. In the FDA efficacy analysis, 37.4% of Besremi-treated patients achieved a durable modified European LeukemiaNet response at both Months 9 and 12 versus 3.6% with anagrelide. The response definition incorporated blood-count remission, improvement or non-progression of splenomegaly, and absence of bleeding or thrombotic events Anagrelide (Agrylin), the direct comparator in SURPASS-ET, was the last drug to receive FDA approval in ET — in 1997 — and remains the only previously approved agent with an explicit ET label indication. Merck & Co.'s bomedemstat, an oral lysine-specific demethylase 1 inhibitor, is currently in Phase III development for cytoreductive therapy-naive ET patients (Shorespan-007; NCT06456346), representing the most advanced pipeline competitor in the same population now covered by Besremi's label. PharmaEssentia said Besremi for ET is available in the US immediately. The company retains full global intellectual property rights across all indications. The ET approval follows recent regulatory decisions in Japan and Taiwan for the same indication, further extending Besremi's international MPN label. Spot something wrong? Report an issue with this article

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the successful completion of the acquisition of Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN). “The Terns acquisition reflects Merck’s continued focus on science‑driven, value‑enhancing business development aimed at bringing meaningful innovation to patients,” said Robert M. Davis, chairman and chief executive officer, Merck. “We believe TERN‑701 has the potential to become a differentiated treatment option for certain patients with chronic myeloid leukemia, and we look forward to working with the Terns team to advance its clinical development.” TERN-701 was recently granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs). The BTD designation for TERN-701 is based on data from the ongoing Phase 1/2 CARDINAL trial (NCT06163430). Merck completed the cash tender offer, through a subsidiary, for all the outstanding shares of common stock of Terns at a purchase price of $53.00 per share, without interest and subject to any applicable tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on May 4, 2026, 100,091,794 shares of Terns common stock were validly tendered and not validly withdrawn, representing approximately 86.36% of the total number of Terns’ issued and outstanding shares of common stock as of such date and time. All such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck, on behalf of its subsidiary, will promptly pay for such shares. Following the completion of the tender offer, Merck completed the acquisition of Terns through a merger of Merck’s wholly-owned subsidiary with and into Terns, with Terns being the surviving corporation, in which all shares of Terns common stock issued and outstanding at the effective time of the merger were converted into the right to receive cash equal to the $53.00 offer price per share, without interest and subject to any applicable tax withholding. At the completion of the merger, Terns became a wholly-owned subsidiary of Merck and Terns’ common stock will no longer be listed or traded on the Nasdaq Global Select Market. The transaction is expected to be accounted for as an asset acquisition, resulting in a charge to research and development expense of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results. Additionally, GAAP and non-GAAP EPS are expected to be negatively impacted by approximately $0.12 per share in 2026, representing costs associated with advancing TERN-701 and costs of financing. TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon existing treatments for certain patients with chronic myeloid leukemia (CML). Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth. Merck is advancing a pipeline of hematology candidates targeting a diverse range of targets across leukemias, lymphomas and myeloproliferative neoplasms. Candidates in Phase 3 development include: bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor; and zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Additionally, MK-1045, an investigational CD19xCD3 T-cell engager, is currently being evaluated in a Phase 1b/2 trial. At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. The content above comes from the network. if any infringement, please contact us to modify.