Ionis, AstraZeneca eplontersen application accepted by FDA for nerve damage disorder
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- The US FDA has accepted a New Drug Application submitted by Ionis Pharmaceuticals (NASDAQ:IONS) for eplontersen for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
- The FDA action date is Dec. 22.
- The agency said it does not plan on holding an advisory committee meeting for the application.
- Ionis (IONS) is partnered with AstraZeneca (NASDAQ:AZN) on the candidate.
- Ionis (IONS) said that patients with ATTRv-PN experience ongoing debilitating nerve damage throughout the body resulting in the progressive loss of motor function.
- Read why Seeking Alpha contributor Out of Ignorance rates Ionis (IONS) a hold.