Arrowhead Pharmaceuticals Receives FDA Breakthrough Therapy Designation for Plozasiran in Severe Hypertriglyceridemia
Arrowhead Pharmaceuticals, Inc. (ARWR)
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Source: Business Wire
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL). There are currently limited and inadequate treatment options for the millions of people globally living with SHTG.Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on clinically significant endpoints1.Arrowhead is on schedule to complete the SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 clinical studies of plozasiran in mid-2026 and intends to submit a supplemental New Drug Applicatio
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ARWR
Earnings
- 11/25/25 - Miss
ARWR
Sec Filings
- 12/5/25 - Form 144
- 12/1/25 - Form 4
- 11/28/25 - Form 144
- ARWR's page on the SEC website