FDA Grants Plozasiran STAR Program Entry, Cutting Review Time to 6 Months
ARWR sits 78% above its 52-week low of $34.61.
Summary
The FDA granted plozasiran entry into the STAR pilot program for the upcoming sNDA in severe hypertriglyceridemia. This qualifies the application for a 6-month Priority Review instead of the standard 10-month review, with possible expedited action at least one month before the goal date. Arrowhead retains the Priority Review Voucher purchased in August 2026, which can now be redeployed or monetized. The company remains on schedule to submit the sNDA by year-end 2026. This follows the strong Phase 3 SHASTA-3 and SHASTA-4 data presented at ESC Congress in August.
At the time of this announcement, ARWR was trading at $61.54 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.7B. The 52-week trading range was $34.61 to $95.49. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.