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Arrowhead Pharmaceuticals Reaffirms 2026 FDA Filing Timeline for Plozasiran

BullishMedium impact
ARWR$62.75 3.31%

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) announced that its regulatory plans for plozasiran remain on schedule. The biotechnology firm expects to submit a supplemental New Drug Application for severe hypertriglyceridemia to the U.S. Food and Drug Administration by the end of 2026, followed by additional global regulatory submissions.

The upcoming submission represents a key regulatory milestone for the company's severe hypertriglyceridemia treatment. Alongside the timeline update, the firm confirmed plans to release interim trial results for ARO-MAPT, a candidate in its central nervous system pipeline. Shares of the company rose 3.31% to $62.75 following the update.

Investors will monitor the upcoming release of the interim ARO-MAPT study results and the same-day corporate webinar detailing central nervous system pipeline developments. Market participants will also track advancement toward the late-2026 FDA filing and subsequent international regulatory expansion.

Key points

  • Arrowhead Pharmaceuticals expects to submit a plozasiran sNDA for severe hypertriglyceridemia to the FDA by year-end 2026.
  • The company plans to follow its FDA submission with additional international regulatory filings.
  • Interim clinical trial results for ARO-MAPT will be released alongside a webinar on the CNS pipeline.
  • Arrowhead Pharmaceuticals shares gained 3.31% to reach $62.75.

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Questions and answers

When will Arrowhead Pharmaceuticals submit its FDA filing for plozasiran?

Arrowhead Pharmaceuticals expects to file a supplemental New Drug Application for plozasiran to treat severe hypertriglyceridemia with the FDA by the end of 2026, followed by international filings.

What upcoming data readout has Arrowhead Pharmaceuticals announced?

Arrowhead Pharmaceuticals will release interim clinical trial results for ARO-MAPT and hold a same-day webinar to present updates on its central nervous system pipeline.