StreetInsider.com News Articles

FDA grants Arrowhead's plozasiran entry into STAR pilot program

Wed, 07 Oct 2026 07:30:48 -0400

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration has granted plozasiran entry into the Split Real Time Application Review (STAR) pilot program, in connection with the company's planned supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG).

The FDA STAR pilot program is designed to shorten the time from a complete sNDA submission to the action date for certain supplemental indications of already-approved drugs. To qualify, the FDA must determine that clinical evidence from adequate and well-controlled investigations indicates the drug may demonstrate substantial improvement on a clinically relevant endpoint over available therapies.

Programs accepted into the STAR

FDA grants Arrowhead's plozasiran entry into STAR pilot program

Wed, 07 Oct 2026 07:30:48 -0400

Programs accepted into the STAR

Arrowhead Pharmaceuticals Granted Entry in the FDA STAR Pilot Program for Plozasiran in Severe Hypertriglyceridemia

Wed, 07 Oct 2026 07:30:00 -0400

- FDA STAR pilot program aims to shorten the time from complete supplement submission to the action date to allow earlier patient access to therapies that address an unmet medical need

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted plozasiran entry in the Split Real Time Application Review (STAR) pilot program in connection with Arrowhead’s upcoming supplemental new drug application (sNDA) for severe hypertriglyceridemia (sHTG). SHTG is a condition that significantly increases the risk of acute pancreatitis, which is associated

Arrowhead Pharmaceuticals Granted Entry in the FDA STAR Pilot Program for Plozasiran in Severe Hypertriglyceridemia

Wed, 07 Oct 2026 07:30:00 -0400

- FDA STAR pilot program aims to shorten the time from complete supplement submission to the action date to allow earlier patient access to therapies that address an unmet medical need

Arrowhead Pharmaceuticals to hold ARO-MAPT webinar Oct. 14

Tue, 29 Sep 2026 07:30:40 -0400

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced it will host an R&D webinar on October 14, 2026, at 11:30 AM PDT focused on its investigational therapy ARO-MAPT and its central nervous system pipeline.

The webinar will include interim clinical data from the AROMAPT-SC-1001 Phase 1/2a study, a placebo-controlled, dose-escalating trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MAPT in up to 64 healthy volunteers and up to 48 subjects with early Alzheimer's disease.

Adam Boxer, M.D., Ph.D., a professor in the Department of Neurology at the University of California, San Francisco, is scheduled to present alongside Arrowhead management. The approximately 60-minute session will

Arrowhead Pharmaceuticals to Host a Webinar with Interim Clinical Data from a Phase 1/2a Study of ARO-MAPT for the Treatment of Alzheimer’s Disease and Other Tauopathies

Tue, 29 Sep 2026 07:30:00 -0400

– ARO-MAPT utilizes the Targeted RNAi Molecule (TRiM™) platform designed for subcutaneous administration and systemic delivery to the CNS by crossing the blood-brain barrier –

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced its plan to host an R&D webinar on Wednesday, October 14, 2026, at 11:30 AM PDT that will focus on investigational therapy ARO-MAPT and Arrowhead’s central nervous system (CNS) pipeline. The webinar will feature a presentation from Adam Boxer, M.D., Ph.D., Endowed Professor in Memory and Aging in the Department of Neurology at the University of California, San

Arrowhead Pharmaceuticals to Host a Webinar with Interim Clinical Data from a Phase 1/2a Study of ARO-MAPT for the Treatment of Alzheimer’s Disease and Other Tauopathies

Tue, 29 Sep 2026 07:30:00 -0400

– ARO-MAPT utilizes the Targeted RNAi Molecule (TRiM™) platform designed for subcutaneous administration and systemic delivery to the CNS by crossing the blood-brain barrier –

Goldman Sachs Assumes Arrowhead Pharma (ARWR) at Neutral

Thu, 24 Sep 2026 05:33:28 -0400

(Updated - September 24, 2026 5:33 AM EDT)

Goldman Sachs analyst Andrea Newkirk assumes coverage on Arrowhead Pharma (NASDAQ: ARWR) with a Neutral rating and a price target of $74.00.

The analyst comments "ARWR is a commercial-stage global biopharmaceutical company leveraging its proprietary Targeted RNAi Molecule (TRiM) platform to develop tissue-specific gene-silencing therapies across cardiometabolic, pulmonary, renal, and neurodegenerative diseases. The company's first commercial product, Redemplo (plozasiran), is approved globally as the first and only siRNA treatment for familial chylomicronemia syndrome (FCS) studied in both clinically and genetically confirmed patients. The primary near-term growth driver is plozasiran's expansion into severe hypertriglyceridemia (sHTG),

Goldman Sachs Assumes Arrowhead Pharma (ARWR) at Neutral

Thu, 24 Sep 2026 05:33:28 -0400

(Updated - September 24, 2026 5:33 AM EDT)

Goldman Sachs analyst Andrea Newkirk assumes coverage on Arrowhead Pharma (NASDAQ: ARWR) with a Neutral rating and a price target of $74.00.

Arrowhead reports early data for dual-gene RNAi therapy ARO-DIMER-PA

Tue, 15 Sep 2026 07:31:16 -0400

Arrowhead Pharmaceuticals (NASDAQ: ARWR) released interim topline data from a Phase 1/2a clinical trial of ARO-DIMER-PA, an investigational RNA interference (RNAi) therapeutic being studied as a potential treatment for atherosclerotic cardiovascular disease due to mixed hyperlipidemia.

ARO-DIMER-PA is designed to silence two genes simultaneously — proprotein convertase subtilisin kexin 9 (PCSK9) and apolipoprotein C3 (APOC3) — using a single RNAi molecule. According to the company, it is the first clinical candidate designed to selectively silence two genes with a single RNAi molecule.

In the single-dose portion of the trial, participants with mixed hyperlipidemia showed dose-dependent mean maximal reductions in serum PCSK9 of

Arrowhead reports early data for dual-gene RNAi therapy ARO-DIMER-PA

Tue, 15 Sep 2026 07:31:16 -0400

In the single-dose portion of the trial, participants with mixed hyperlipidemia showed dose-dependent mean maximal reductions in serum PCSK9 of

Arrowhead Pharmaceuticals Announces Interim Topline Clinical Data for the First Dual-Functional RNAi Therapeutic for the Treatment of Mixed Hyperlipidemia

Tue, 15 Sep 2026 07:30:00 -0400

- ARO-DIMER-PA achieved deep and durable silencing of two genes with a single RNAi molecule

- Mean maximal single dose reductions in serum PCSK9 of 72% and APOC3 of 88%

- Clinical validation further demonstrates Arrowhead’s position as the leading innovator in siRNA therapies -

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced interim topline data from a Phase 1/2a clinical trial of ARO-DIMER-PA, the company’s first investigational RNA interference (RNAi) therapeutic dimer being developed as a potential treatment for atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia. ARO-DIMER-PA is designed

Arrowhead Pharmaceuticals Announces Interim Topline Clinical Data for the First Dual-Functional RNAi Therapeutic for the Treatment of Mixed Hyperlipidemia

Tue, 15 Sep 2026 07:30:00 -0400

- ARO-DIMER-PA achieved deep and durable silencing of two genes with a single RNAi molecule

- Mean maximal single dose reductions in serum PCSK9 of 72% and APOC3 of 88%

- Clinical validation further demonstrates Arrowhead’s position as the leading innovator in siRNA therapies -

Citi Starts Arrowhead Pharma (ARWR) at Buy

Tue, 08 Sep 2026 01:50:44 -0400

Citi analyst Eric Joseph initiates coverage on Arrowhead Pharma (NASDAQ: ARWR) with a Buy rating and a price target of $108.00.

For an analyst ratings summary and ratings history on Arrowhead Pharma click here. For more ratings news on Arrowhead Pharma click here.

Shares of Arrowhead Pharma closed at $86.34 yesterday.

Piper Sandler on Biotechnology: 'Look for Biotech to Outperform through YE:26'