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FDA pauses enrollment in Biohaven's opakalim trials; pivotal readout remains on track
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Fusion42 · 11 September 2026 · Fusion42 review
The FDA has issued a partial clinical hold on Biohaven's opakalim trials, pausing new patient enrollment pending additional nonclinical metabolite studies, while dosing continues for already enrolled patients and the pivotal trial readout timeline remains unaffected.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.
◆ ◆ The Wire takeaway
The FDA pause sends a warning signal to biotech founders developing Kv7 activators that nonclinical safety findings can delay enrollment even when pivotal readouts stay on track. You need to build contingencies for unexpected regulatory holds when licensing late-stage assets or planning US trial enrolments.
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3 sources · 10 Sep 2026
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