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ARTICLE | Regulation

Dec. 21 Quick Takes: FDA’s approval of eplontersen sets up challenge to Alnylam’s Amvuttra  

Plus: Cytokinetics gains on takeout talk and updates from Lilly-Fauna, Sanofi, Illumina, BioMarin, MeiraGTx and more

December 22, 2023 2:01 AM UTC

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) and AstraZeneca plc (LSE:AZN; NASDAQ:AZN) said Wainua eplontersen would be available in the U.S. in January following FDA’s approval of the antisense oligonucleotide to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTR). The therapy will compete with Amvuttra vutrisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), which was approved for the indication in June 2022. Both products are being studied to treat the cardiomyopathy form of ATTR, a much larger indication. AstraZeneca paid Ionis $200 million up front in December 2021 for the ex-U.S. rights to Wainua; the partners share U.S. rights.

Shares of Cytokinetics Inc. (NASDAQ:CYTK) rose 25% to $44.82 Thursday on reports that Novartis AG (SIX:NOVN; NYSE:NVS) and AstraZeneca plc (LSE:AZN; NASDAQ:AZN) have explored an acquisition of the company. The rumors come ahead of a top-line readout due in late December from the Phase III SEQUOIA-HCM trial of cardiac myosin inhibitor aficamten to treat hypertrophic cardiomyopathy. Novartis and Cytokinetics both declined to comment; AstraZeneca did not respond to a request for comment ...

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