The BioWorld Biopharmaceutical Index finished 2025 up 24.07%, building slightly on its 23% gain recorded at the end of November. While the increase trailed the Nasdaq Biotechnology Index’s 32.4% rise for the year, it outperformed the broader Dow Jones Industrial Average, which advanced 12.97%.

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.

BioWorld tracked 144 clinical trial readouts across phases I through III in January 2026, down from 215 in December. January included 15 phase III trials reporting positive results and three that failed to meet key endpoints. By phase, the month’s updates consisted of 60 from phase I, 44 from phase II and 40 from phase III.

U.S. med-tech companies are optimistic about the year ahead and believe that they are well positioned to navigate geopolitical headwinds and the uncertainty that they bring. Their technologies, which span neurosurgery and tissue reconstruction to cardiology and radiation protection, address important clinical needs. With the major U.S. corporates accelerating dealmaking and acquisitions, these companies see strong momentum building for the year ahead.

At Biocom’s Global Partnering and Investor Conference, representatives from the business development departments at various pharmaceutical companies provided an update on their appetites for deals. The mood was fairly upbeat because, let’s face it, large pharma has become dependent on external development.

The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.