On May 12, 2024, Arrowhead Pharmaceuticals, Inc. (ARWR) announced financial results for the second quarter of fiscal year 2025 that ended March 31, 2025. Arrowhead is set up with multiple value drivers in both the near- and long-term. Most importantly, the NDA for plozasiran for the treatment of familial chylomicronemia syndrome (FCS) is currently under review by the FDA and has a PDUFA date of November 18, 2025. The submission of a MAA with the EMA is complete and additional regulatory filings are expected in other jurisdictions. The Phase 3 trials for plozasiran in SHTG should be fully enrolled this summer. The Phase 1/2 trial of ARO-INHBE is enrolling, the Phase 1/2 trial of ARO-ALK7 will begin enrolling shortly, and data for ARO-INHBE could be available before the end of 2025, with data for ARO-ALK7 following shortly thereafter. The company currently has approximately $1.1 billion in cash and investments and is funded into 2028.
