The regulatory clouds that have been darkening the U.S. FDA landscape of late for Uniqure NV’s gene therapy AMT-130 in Huntington’s disease may be parting a bit with the announced departure of Vinay Prasad as director of the agency’s CBER at the end of April.
Biopharma financings totaled $16.78 billion in the first two months of 2026, about an 81% year-over-year rise from $9.28 billion in January to February 2025. While still below the outsized $33.29 billion recorded in the same period of 2024, and $24.37 billion in 2021, the early 2026 total significantly outpaces the more subdued levels seen in 2022 ($7.48 billion) and 2023 ($7.66 billion).
The OX40-targeting mechanism pursued by drug developers around the world found itself shadowed March 3 when Kyowa Kirin Co. Ltd. gave up work with rocatinlimab, a monoclonal antibody for which hopes had risen in moderate to severe atopic dermatitis, prurigo nodularis and moderate to severe asthma.
Oddsmakers wasted no time figuring the market chances after Merck & Co. Inc. rolled out data from the phase III Litespark-011 study testing its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in advanced renal cell carcinoma.
The U.S. FDA clearance Feb. 20 of East Windsor, N.J.-based Acrotech Biopharma Inc.’s PDE4 inhibitor Adquey (difamilast ointment 1%) for mild to moderate atopic dermatitis brought renewed focus on the mechanism, where other drugs are already approved and more are stocking developers’ pipelines across indications.