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Arrowhead Pharmaceuticals, Inc. is a publicly traded biopharmaceutical company based in Pasadena, California. Arrowhead's products in development act through RNA interference (RNAi) mechanisms of action.
The Investor Relations website contains information about Arrowhead Pharmaceuticals Inc.'s business for stockholders, potential investors, and financial analysts.
ir.arrowheadpharma.com
Arrowhead Pharmaceuticals Granted Entry in the FDA STAR Pilot Program for Plozasiran in Severe Hypertriglyceridemia
PASADENA, Calif.--(BUSINESS WIRE)--Oct. 7, 2026--
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted plozasiran entry in the Split Real Time Application Review (STAR) pilot program in connection with Arrowhead’s upcoming supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG). SHTG is a condition that significantly increases the risk of acute pancreatitis, which is associated with repeated hospital admissions and can be fatal.
The FDA STAR pilot program aims to shorten the time from the date of a complete sNDA submission to the action date for certain supplemental indications for already-approved drugs. To be granted entry in the STAR program, FDA must determine that clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.
Once accepted into the STAR program, a supplemental application qualifies for a 6-month Priority Review compared to a 10-month standard review. In addition, FDA will generally target an “expedited review” for efficacy supplements in the STAR program, meaning an action at least 1 month before the Priority Review goal date is possible. The use of a Priority Review Voucher (PRV) is not necessary for programs that are granted entry in the STAR program, so Arrowhead retains the PRV previously purchased in August 2026.
“We are committed to pursuing every potential opportunity to accelerate the process of bringing plozasiran to patients, and the FDA STAR Pilot program provides important benefits to sponsors with efficacy supplements,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. “In addition, earning Priority Review for plozasiran without the need to use a PRV gives us the option to redeploy our voucher for a future application or monetize it.”
Arrowhead is on schedule to submit a sNDA for plozasiran in sHTG to the FDA by year-end 2026 and plans to seek regulatory approval with additional global regulatory authorities thereafter. Plozasiran has received regulatory approval, as REDEMPLO®, in the United States, the European Union, China, Australia, and Canada as an adjunct to diet to reduce triglycerides in adults with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), which is the most severe form of sHTG.
The Investor Relations website contains information about Arrowhead Pharmaceuticals Inc.'s business for stockholders, potential investors, and financial analysts.
ir.arrowheadpharma.com
Arrowhead Pharmaceuticals Announces NMPA Approval of REDEMPLO® (plozasiran) for Familial Chylomicronemia Syndrome (FCS) in China
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the Chinese National Medical Products Administration (NMPA) has approved REDEMPLO
® (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.
REDEMPLO will be marketed in Greater China by Sanofi under an agreement between Sanofi and Arrowhead. In 2025, Sanofi purchased those rights from Visirna, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead’s investigational cardiometabolic candidates in Greater China.
Approval in China marks the third regulatory approval for REDEMPLO, following recent approvals by U.S. Food and Drug Administration (FDA) and Health Canada, as an adjunct to diet to reduce triglycerides in adults with FCS. REDEMPLO is also in review for marketing authorization by additional global regulatory authorities.
REDEMPLO is the first and only U.S. FDA-approved, Health Canada-approved, and China NMPA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months.
“NMPA approval of REDEMPLO for FCS in China is another positive step and continues the strong momentum since launching in the U.S. in November 2025. We look forward to working with Sanofi, an innovative global company with an established presence in China,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “We are happy to report encouraging initial response from physicians and patients following FDA approval and launch in the U.S. last month. We intend to continue building on this rapid progress and anticipate additional commercial launches in 2026, pending regulatory review and approval.”
