Uniqure NV is the latest firm to get caught between the FDA’s shifting demands for “gold standard” science and regulatory flexibility for rare disease therapies. The company disclosed in its latest earnings report that U.S. regulators are calling for a sham-controlled study before they will consider approval of gene therapy AMT-130 in Huntington’s disease, a requirement that could set the program back by two to three years and raises potential ethical issues.

What does med tech in 2026 look like? Uncertainty remains. Global investors are confident about exit opportunities in the year ahead. But financing will be targeted. For the med-tech companies, geopolitical tensions continue to create headwinds, particularly for the European firms navigating an uncertain macroenvironment created by the reciprocal tariffs on goods entering the U.S., their primary market. By contrast, U.S. companies are bullish and believe they are well-positioned to navigate macroeconomic pressures. Still, across both regions, there is confidence in the sector and companies remain focused on advancing their technologies to address clinical needs – innovating, conducting trials, presenting data, raising funds, and delivering products that improve patients’ lives.

CAR T cells have been groundbreaking for the treatment of B-cell cancers. But 8 years after Kymriah (tisagenlecleucel, Novartis AG) became the first CAR T-cell therapy to be approved, there are no CAR Ts approved for solid tumors.