As the march toward a new therapy continues in metabolic dysfunction-associated steatohepatitis (MASH), new approaches are drawing Wall Street’s attention. Among them is Inventiva SA’s pan-PPAR approach.

BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October.

After reaching their peaks in late November, both the BioWorld Drug Developers Index and the Nasdaq Biotechnology Index finished the year slightly down from those highs.

Full-year biopharma deal value in 2025 reached $292.55 billion, the highest annual total in BioWorld’s records, following $78.93 billion in the fourth quarter (Q4). The annual total is a 27% increase from the $230.53 billion recorded in 2024.

After a “brutal” year, there is reason for optimism, with the fourth quarter seeing an upswing in deal numbers and the amount raised, according to the UK Bioindustry Association’s final tally of biotech financing in 2025.

The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.

Despite pressure on drug pricing, an ongoing threat of tariffs and rising geopolitical tension, the outlook for dealmaking in 2026 is strong. Balanced against the fog of uncertainty, which the industry is navigating, is the stark reality of the coming patent cliff and the fact that the big pharma companies have access to $1.619 trillion with which to replenish their pipelines.

Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.