Wave Plans To Pursue Accelerated Approval For Huntington’s Drug

NfL Concern From Early Trial May Be Overblown

The biotech said it plans to engage with regulators before the end of the year for the Takeda-partnered antisense oligonucleotide, WVE-003, to discuss a pivotal trial that would support accelerated approval.

Wave Life Sciences Ltd. is hoping to sit down with regulators before the year is over to talk about potential accelerated approval for WVE-003 in Huntington’s disease following positive Phase Ib/IIa efficacy data. While there are potential safety concerns about neurofilament light (NfL) protein levels, the company is hoping to mitigate it through less frequent dosing, and analysts suggested the concerns may be overblown.

Wave announced results from the SELECT-HD clinical trial of WVE-003, an allele-selective antisense oligonucleotide partnered with Takeda Pharmaceutical Co. Ltd., on 25 June. The drug is designed to lower...

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