Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) began the trading day slightly in the green, on the announcement 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 six-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 one 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.
ARWR shares eked ahead eight cents to $61.62.
