Citi says approval ‘likely’ for Ionis’ eplontersen ATTR-PN NDA

Citi analyst David Lebowitz notes that the FDA decision on eplontersen’s NDA for ATTR-polyneuropathy, or ATTR- PN, is expected on or before the PDUFA action date of December 22 and the firm views approval as “likely,” supported by 35-week data from the pivotal NEURO-TTRansform trial showing significant improvement in its co-primary endpoints. The firm, which calls a U.S. approval “highly probable,” believes eplontersen’s efficacy, safety, and convenient at-home subcutaneous administration will allow it to take “a meaningful share” of the large ATTR-CM market, but thinks Alnylam’s (ALNY) Amvuttra is likely to remain “the ATTR-PN market leader,” the analyst added. Citi keeps a Buy rating and $60 price target on Ionis Pharmaceuticals (IONS) shares.