On August 5, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2019 third quarter ended June 30, 2019 (Press release, Arrowhead Research Corporation, AUG 5, 2019, View Source [SID1234538129]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.
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Conference Call and Webcast Details
Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 3249189.
A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 3249189.
Selected Fiscal 2019 Third Quarter and Recent Events
Received U.S. Food and Drug Administration (FDA) clearance to begin an adaptive design Phase 2/3 trial, called SEQUOIA, with the potential to serve as a pivotal registrational study of ARO-AAT, Arrowhead’s second generation subcutaneously administered RNAi therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency
Secured first regulatory clearance in the United Kingdom for the ARO-AAT 2002 study, a pilot open-label, multi-dose, Phase 2 study to assess changes in a novel histological
activity scale in response to ARO-AAT over time in patients with alpha-1 antitrypsin deficiency associated liver disease
Expanded the AROHBV1001 Phase 1/2 study to include a new triple combination cohort that includes: JNJ-3989, formerly ARO-HBV; JNJ-6379, Janssen’s investigational orally administered capsid assembly modulator of the class that forms normal capsid structures; and, a nucleos(t)ide analog, or NUC
In connection with the start of dosing of this cohort, Arrowhead earned a $25 million milestone payment from Janssen
Received orphan drug designation from FDA for ARO-APOC3 for the treatment of familial chylomicronemia syndrome
Received FDA Fast Track designation for ARO-AAT
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier
Received orphan drug designation from FDA for ARO-ANG3 for the treatment of homozygous familial hypercholesterolemia
Completed discovery and development work on ARO-HSD, a previously undisclosed liver-targeted candidate targeting HSD17B13, a hydroxysteroid dehydrogenase involved in the metabolism of hormones, fatty acids and bile acids, that is now in IND-enabling GLP-toxicology studies, and, pending success in the tox program, on schedule for a CTA filing at the end of 2019
Started IND-enabling GLP-toxicology studies for ARO-HIF2, designed to inhibit the production of HIF-2a for the treatment of clear cell renal cell carcinoma, to support, pending success in the tox program, a CTA filing at the end of 2019
Completed dosing in the single-ascending dose portions of the Phase 1 studies of Arrowhead’s two wholly-owned cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, and progressed towards the multiple-dose portions of the Phase 1 studies in various patient populations