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Arrowhead Pharmaceuticals (ARWR) FDA Events

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FDA Events for Arrowhead Pharmaceuticals (ARWR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Arrowhead Pharmaceuticals (ARWR). Over the past two years, Arrowhead Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ARO-ALK7, ARO-CFB, ARO-INHBE, ARO-RAGE, plozasiran, and Zodasiran. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Arrowhead Pharmaceuticals' Drugs in FDA Review

ARO-ALK7 - FDA Regulatory Timeline and Events

ARO-ALK7 is a drug developed by Arrowhead Pharmaceuticals for the following indication: For the Treatment of Obesity. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARO-CFB - FDA Regulatory Timeline and Events

ARO-CFB is a drug developed by Arrowhead Pharmaceuticals for the following indication: Treatment of Complement Mediated Diseases. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARO-INHBE - FDA Regulatory Timeline and Events

ARO-INHBE is a drug developed by Arrowhead Pharmaceuticals for the following indication: For the treatment of obesity and metabolic diseases. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ARO-RAGE - FDA Regulatory Timeline and Events

ARO-RAGE is a drug developed by Arrowhead Pharmaceuticals for the following indication: Asthma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

plozasiran - FDA Regulatory Timeline and Events

plozasiran is a drug developed by Arrowhead Pharmaceuticals for the following indication: In Patients with Familial Chylomicronemia Syndrome. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Zodasiran - FDA Regulatory Timeline and Events

Zodasiran is a drug developed by Arrowhead Pharmaceuticals for the following indication: For the Treatment of Homozygous Familial Hypercholesterolemia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Arrowhead Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Arrowhead Pharmaceuticals (ARWR) has reported FDA regulatory activity for the following drugs: plozasiran, ARO-ALK7, ARO-INHBE, Zodasiran, ARO-CFB and ARO-RAGE.

The most recent FDA-related event for Arrowhead Pharmaceuticals occurred on July 8, 2025, involving Zodasiran. The update was categorized as "Dose Update," with the company reporting: "Arrowhead Pharmaceuticals, Inc. announced that it has dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated LDL-cholesterol and early onset cardiovascular disease."

Current therapies from Arrowhead Pharmaceuticals in review with the FDA target conditions such as:

  • In Patients with Familial Chylomicronemia Syndrome - plozasiran
  • For the Treatment of Obesity - ARO-ALK7
  • For the treatment of obesity and metabolic diseases - ARO-INHBE
  • For the Treatment of Homozygous Familial Hypercholesterolemia - Zodasiran
  • Treatment of Complement Mediated Diseases - ARO-CFB
  • Asthma - ARO-RAGE

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ARWR) was last updated on 7/10/2025 by MarketBeat.com Staff
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