Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) skyrocketed to a five-year high on Wednesday, as investors began positioning portfolios ahead of the supplemental new drug application (sNDA) of its drug candidate, plozasiran, for the treatment of severe hypertriglyceridemia.
In intra-day trading, the stock soared by as much as 28 percent to a record high of $95.49—a level it last touched in 2021.
Strong Phase 3 Trials
In an updated report on the same day, Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) said that it is targeting to submit an sNDA for plozasiran before the end of the year following the strong results from two late-stage clinical trials.
In the phase 3 studies, 25 mg of plozasiran given to patients once every three months successfully reduced triglyceride levels by 79 percent and 81 percent, respectively, versus only 27 percent in the placebo group.
Additionally, it was able to reduce the overall number of acute pancreatitis cases by 78 percent among patients with severe high triglycerides.
Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) also said that plozasiran continued to show a favorable safety profile without major new safety concerns, side effects, or serious immune or blood platelet problems.
For illustration purposes only. Photo by M.A Arkhipov on Shutterstock
sNDA for Expanded Use
Because plozasiran is already an approved drug to treat another rare genetic disorder, Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) said that it will seek a supplemental NDA for its expanded use with the Food and Drug Administration by the end of the year.
In November 2025, plozasiran, also called Redemplo, was approved by the FDA to treat patients with familial chylomicronemia syndrome, which affects 6,500 people in the US alone.
FCS is a severe, rare disease characterized by triglyceride levels that can shoot up by 10 to 100x higher than normal, leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.
Apart from the US, Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) has also received regulatory approvals from Europe, Australia, and Canada for plozasiran to treat FCS.
Q3 Earnings, ESC 2026
In other news, Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) said that it is scheduled to announce the results of its third-quarter earnings ending June 30, 2026, after market close on August 4. A conference call will be held to elaborate on the results.
It will also present detailed results from the recent phase 3 trials at the ESC 2026 on August 30, 2026.
Hedge Fund Conviction Drops
Despite developments surrounding the company’s pipeline, hedge fund conviction noticeably softened in Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR).
Based on data from Insider Monkey, 53 hedge funds held positions in its stock, unchanged from the quarter prior.
However, the value of their combined holdings notably declined by 8.9 percent to $1.74 billion from $1.91 billion quarter-on-quarter, signaling that positions remained limited while they wait for more concrete developments on its pipeline.
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