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Jun 30
Arrowhead Pharmaceuticals Q3 2025 Earnings Report
Arrowhead Pharmaceuticals reported its fiscal 2025 third quarter results, highlighting strong execution in discovery, clinical and regulatory, and business development.
Key Takeaways
Arrowhead Pharmaceuticals reported a net loss of $175.241 million for the fiscal third quarter of 2025, with revenue of $27.767 million. The company maintained a strong balance sheet with total cash resources of $900.372 million and advanced several key pipeline candidates, including plozasiran, zodasiran, and ARO-ALK7, into late-stage or early-stage clinical trials.
Arrowhead Pharmaceuticals reported revenue of $27.767 million for the fiscal third quarter of 2025.
The company posted a net loss of $175.241 million, or $1.26 per diluted share, for the quarter.
Total cash resources stood at $900.372 million as of June 30, 2025, indicating a strong financial position.
The company advanced multiple pipeline candidates, with plozasiran's NDA accepted by the FDA and a PDUFA date set for November 18, 2025, and zodasiran and ARO-ALK7 entering Phase 3 and Phase 1/2a trials, respectively.
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals
Forward Guidance
Arrowhead Pharmaceuticals anticipates completing the primary portion of plozasiran's SHASTA-3, SHASTA-4, and MUIR-3 studies in mid-2026, with topline data expected shortly thereafter and planned regulatory submissions. The company also expects to achieve the second enrollment target for ARO-DM1 by the end of 2025, triggering an additional $200 million milestone payment.
Positive Outlook
- Plozasiran's NDA has been accepted by the U.S. FDA with a PDUFA action date of November 18, 2025.
- Completion of enrollment in plozasiran's global Phase 3 clinical studies (SHASTA-3, SHASTA-4, and MUIR-3) with topline data expected in mid-2026.
- Dosing of the first subject in the YOSEMITE Phase 3 clinical trial for zodasiran, marking it as the fourth RNAi candidate in late-stage pivotal studies.
- Dosing of the first subjects in a Phase 1/2a clinical trial for ARO-ALK7, a potential obesity treatment with a novel mechanism of action.
- Anticipated achievement of the second enrollment target for ARO-DM1 by the end of 2025, triggering a $200 million milestone payment from Sarepta Therapeutics.
Challenges Ahead
- The primary portion of plozasiran's SHASTA studies will not be completed until mid-2026, delaying potential regulatory submissions.
- The company's forward-looking statements are subject to numerous factors and uncertainties, including the safety and efficacy of product candidates and regulatory decisions.
- There is no guarantee that the ARO-DM1 milestone will be achieved on projected timelines or that payment will be received.
- Rapid technological change in the markets could impact the company's competitive position.
- The company disclaims any intention to update or revise forward-looking statements, indicating potential for uncommunicated changes.