uniQure's Huntington's Disease Therapy Aims for FDA Approval in 2026
uniQure, a gene therapy company, plans to seek FDA approval for its Huntington's disease treatment, AMT-130, in early 2026. The therapy has shown promising results, slowing disease progression significantly. Meanwhile, Pfizer has made strategic acquisitions and deals, and GlaxoSmithKline (GSK) has announced a leadership change. Additionally, the U.S. government has implemented new tariffs.
uniQure's AMT-130 demonstrated a 75% reduction in Huntington's disease progression in clinical trials. The company aims to file for FDA approval in the first quarter of 2026. Earlier this year, the Center for Biologics Evaluation and Research (CBER) published recommendations to speed up cell and gene therapy development.
In the pharmaceutical sector, Pfizer has been active. It acquired Metsera for $4.9 billion and struck a most-favored-nation deal with the White House. Additionally, Pfizer and Genmab, along with N2OFF, have made strategic mergers. N2OFF's deal with MitoCareX focuses on mitochondrial-targeted cancer therapies, valued at $700,000 plus 40% equity. Verona Pharma shareholders also approved a $10 billion acquisition by Merck.
Luke Miels will succeed Emma Walmsley as CEO of GSK. Walmsley will step down on Dec. 31, 2025. CDER Director George Tidmarsh recently criticized the use of surrogate endpoints in drug approvals.
President Trump announced 100% tariffs on certain imports, effective Oct. 1, 2025.
uniQure's AMT-130, with its promising results, is poised for FDA approval. Pfizer's strategic planning and GSK's leadership change indicate significant shifts in the pharmaceutical industry. The U.S. government's tariff implementation may impact international trade.
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