IONS

AstraZeneca and California-based biotech Ionis Pharmaceuticals announce a late-stage trial failure for their gene silencing drug, Wainua.

AstraZeneca said ​on Thursday ‌that its drug ​Wainua, ​made in partnership ⁠with ​Ionis , ​failed to meet the ​main ​goal of reducing ‌cardiovascular ⁠deaths and recurring heart ​problems ​in ⁠a late-stage ​trial.

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and partner AstraZeneca today announced that the CARDIO-TTRansform Phase 3 trial for eplontersen in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet the primary efficacy endpoint of the composite outcome of cardiovascular (CV) mortality and recurrent CV clinical events up to Week 140 compared with placebo. In this contemporary patient population treated with standard of care, includin.

Ionis completes enrollment in the pivotal pediatric cohort of its phase III REVEAL study, advancing obudanersen toward potential regulatory submissions.

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has completed enrollment in the pivotal cohort (Cohort 1) of the global Phase 3 REVEAL study evaluating obudanersen (ION582), an investigational RNA-targeted medicine for people living with Angelman syndrome (AS), a serious and rare neurodevelopmental disorder associated with significant impairments in communication, physical function and cognition. The pivotal cohort enrolled 136 participants.

Ionis grants Recordati ex-U.S. rights to zilganersen for Alexander disease while retaining U.S. commercialization and securing upfront and royalty payments.

Ionis Pharmaceuticals, Inc. (IONS) Discusses FDA Approval of TRYNGOLZA for Severe Hypertriglyceridemia and Acute Pancreatitis Risk Reduction Transcript

Ionis wins FDA approval to expand Tryngolza to severe hypertriglyceridemia, opening a broader market as the first approved treatment for the condition.

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has entered into a license agreement with Recordati (“Recordati”), under which Recordati obtained exclusive rights to develop and commercialize zilganersen, an investigational RNA-targeted medicine for Alexander disease (AxD), in all countries outside the U.S. Ionis will maintain sole commercial responsibility for zilganersen in the U.S. and will continue to lead development globally. Recordati.

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA® (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). TRYNGOLZA is available in a 50 mg or 80 mg dose and is self-administered once monthly via an autoinjector. sHTG is characterized by an increased.