ARWR Stock On Track To Hit Over 5-Year Highs – Retail Cheers Phase 3 Breakthrough As Arrowhead Targets Broader FDA Approval

The biotech firm reported positive topline results from two Phase 3 studies evaluating its hypertriglyceridemia therapy.

• The studies met their primary endpoint of reducing triglyceride levels versus placebo and achieved all prespecified secondary endpoints.
• Patients receiving 25 mg of Plozasiran once every three months achieved median triglyceride reductions of 79% in SHASTA-3 and 81% in SHASTA-4 after 12 months, compared with about 27% for placebo.
• The company plans to file a supplemental new drug application to the U.S. FDA by the end of 2026.

Shares of Arrowhead Pharmaceuticals (ARWR) surged more than 18% in pre-market trading on Wednesday and are on track to hit their highest levels in over five years, after the biotech firm reported positive topline results from two Phase 3 studies evaluating its hypertriglyceridemia therapy.

Hypertriglyceridemia occurs due to the presence of excess triglycerides in the blood and is considered a risk factor for cardiovascular disease.

Plozasiran Data Shows Significant Reduction Of Acute Pancreatitis Events

According to the company, the studies met their primary endpoint of reducing triglyceride levels versus placebo and achieved all prespecified secondary endpoints, including a significant reduction in acute pancreatitis events.

Patients receiving 25 mg of Plozasiran once every three months achieved median triglyceride reductions of 79% in SHASTA-3 and 81% in SHASTA-4 after 12 months, compared with about 27% for placebo. Across the overall study population, treatment reduced acute pancreatitis events by 78%.

Arrowhead said Plozasiran continued to demonstrate a favorable safety and tolerability profile, with no new safety signals, no meaningful changes in liver health, and no cases of hypersensitivity or thrombocytopenia.

What’s Next For Arrowhead Pharmaceuticals?

Arrowhead plans to use data from the Phase 3 SHASTA-3, SHASTA-4, and MUIR-3 trials to seek approval for treating severe hypertriglyceridemia in additional markets, starting with a supplemental new drug application (sNDA) to the U.S. FDA by the end of 2026.

Detailed results from the SHASTA-3 and SHASTA-4 studies will be presented as a HOT LINE Late Breaker at the European Society of Cardiology Congress in Munich on Aug. 30, 2026.

Retail Bets On $10B A Year Drug

Retail sentiment surrounding the stock turned ‘bullish’ from ‘neutral’ amid ‘high’ message volumes. ARWR was also among the top trending tickers on the platform at the time of writing.

One bullish user wondered whether Plozasiran could become a “$10 billion per year drug.”

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Another user expects the stock to climb to $100 sooner than expected.

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The stock has gained more than 10% so far this year.

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