Arbli (losartan potassium) / Scienture - LARVOL DELTA

SCIENTURE announces the U.S. FDA Approval of its NDA for SCN-102, to be launched as Arbli, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024. (GlobeNewswire) - "SCIENTURE HOLDINGS, INC...is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli (losartan potassium) Oral Suspension, 10 mg/mL. Arbli is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes.... IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market....'We expect to commercially launch and make Arbli available to patients in the U.S. in Q3 2025'."

FDA approval • Launch US • Sales • Diabetic Nephropathy • Hypertension

Scienture Holdings Announces Draw on ELOC, Temporarily Suspends Further Draws Until Reaching $10/Share or 30 Trading Days (GlobeNewswire) - "SCIENTURE HOLDINGS, INC...today announced it has completed a draw on its Equity Line of Credit (ELOC) to support the commercial launch of Arbli (losartan potassium) Oral Suspension, while simultaneously announcing a temporary suspension of further ELOC draws for the next 30 trading days or until the company's stock reaches $10 per share, whichever occurs first. The strategic financial decision comes on the heels of today's announcement that the U.S. Food and Drug Administration (FDA) has approved Scienture's New Drug Application (NDA) for Arbli, the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market. The draw will provide immediate capital to support pre-launch activities for this novel antihypertensive medication...The company expects to commercially launch Arbli and make it available to patients in the U.S. in Q3 2025."

FDA approval • Financing • Launch US • Cardiovascular • Diabetic Nephropathy • Hypertension