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Wave Plans To Pursue Accelerated Approval For Huntington’s Drug

NfL Concern From Early Trial May Be Overblown

 
• By Alaric DeArment

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.

• Source: Shutterstock

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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Pipeline Watch: Eight Approvals And Nine Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.