Plozasiran Cuts Acute Pancreatitis by 78% in Phase 3, Arrowhead Plans sNDA
ARWR has more than doubled off its 52-week low of $21.61.
Summary
Arrowhead presented detailed Phase 3 SHASTA-3 and SHASTA-4 data at ESC Congress 2026 showing plozasiran reduced triglycerides by 79-81% and acute pancreatitis events by 78% versus placebo in severe hypertriglyceridemia. The pooled analysis showed a 4.1% absolute risk reduction for pancreatitis, with a number needed to treat of 24 overall and 3 in high-risk patients. Safety was favorable with no new signals. The company plans to submit an sNDA to the FDA before end of 2026 for the broader sHTG indication, leveraging the Priority Review Voucher acquired earlier this month. This follows the July topline data and the August 4 Q3 report that highlighted stellar plozasiran pivotal data. The detailed results strengthen the case for label expansion beyond FCS, potentially unlocking a much larger market. A conference call is scheduled for August 31 to discuss the data.
At the time of this announcement, ARWR was trading at $85.24 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12B. The 52-week trading range was $21.61 to $95.49. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.