On August 7, 2025, Arrowhead Pharmaceuticals, Inc. (ARWR) announced financial results for the third quarter of fiscal year 2025 that ended June 30, 2025. The company is continuing preparations ahead of the November 18, 2025 PDUFA date for plozasiran for the treatment of familial chylomycronemia syndrome (FCS). These preparations include hiring a National Sales Leader, a full team of Regional Sales Leaders, and a field force of rare disease specialists. The company will begin engaging key healthcare professionals to advance FCS disease education by the end of this month. The SHASTA-3, SHASTA-4, and MUIR-3 studies of plozasiran in severe hypertriglyceridemia (sHTG) are fully enrolled, with results anticipated next year. The company's wholly-owned subsidiary, Visirna Therapeutics, signed an asset purchase agreement with Sanofi that grants rights to develop plozasiran for FCS and sHTG in Greater China. Visirna will receive $130 million upfront and be eligible to receive milestone payments of up to $265 million along with royalties on net sales.
08 Aug 2025
ARWR: Countdown to Nov. 18, 2025 PDUFA for Plozasiran for FCS
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ARWR: Countdown to Nov. 18, 2025 PDUFA for Plozasiran for FCS
- Published:
08 Aug 2025 -
Author:
David Bautz -
Pages:
7 -
On August 7, 2025, Arrowhead Pharmaceuticals, Inc. (ARWR) announced financial results for the third quarter of fiscal year 2025 that ended June 30, 2025. The company is continuing preparations ahead of the November 18, 2025 PDUFA date for plozasiran for the treatment of familial chylomycronemia syndrome (FCS). These preparations include hiring a National Sales Leader, a full team of Regional Sales Leaders, and a field force of rare disease specialists. The company will begin engaging key healthcare professionals to advance FCS disease education by the end of this month. The SHASTA-3, SHASTA-4, and MUIR-3 studies of plozasiran in severe hypertriglyceridemia (sHTG) are fully enrolled, with results anticipated next year. The company's wholly-owned subsidiary, Visirna Therapeutics, signed an asset purchase agreement with Sanofi that grants rights to develop plozasiran for FCS and sHTG in Greater China. Visirna will receive $130 million upfront and be eligible to receive milestone payments of up to $265 million along with royalties on net sales.