The stock market recently witnessed a significant sell-off of UniQure (a Dutch biotech firm), wiping out nearly $500 million in market capitalization in a single trading session on February 26, 2026. The downturn was triggered by comments made by FDA Commissioner Martin Makary during a televised interview, which investors interpreted as a negative signal for the approval prospects of its Huntington’s disease gene therapy.
The Controversial Remarks Appearing on CNBC, Makary defended the regulator’s rigorous stance on approving therapies for rare diseases. He cited an example of a product administered via a burr hole drilled into the patient’s skull that failed to show clinical benefits in randomized trials. Although no specific company was named, investors and analysts quickly drew parallels to UniQure’s AMT-130 therapy, which utilizes a similar neurosurgical delivery method.
Analyst Reaction and Regulatory Context
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Skepticism: Experts from Stifel and Leerink Partners noted that the technical details mentioned by the FDA chief might not perfectly align with UniQure’s profile and could potentially refer to a recently rejected drug from Regenxbio.
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Regulatory Shift: Previously, in November 2025, UniQure revealed that the FDA had experienced a “change of heart” regarding AMT-130, demanding additional evidence instead of relying on Phase I/II trial data as previously agreed.
This controversy erupted just days before UniQure’s scheduled Q4 earnings report (expected on March 2, 2026), making the market sentiment exceptionally volatile.