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Biotech Stocks Facing FDA Decision In March 2025

Scienture Holdings
Scienture Holdings

Scienture Holdings Inc. (SCNX), which faced a setback in its first attempt to gain FDA approval for its lead drug candidate, SCN-102, a ready-to-use oral suspension of Losartan, is trying its luck for the second time. With its resubmitted New Drug Application now under review, the company is eagerly awaiting a regulatory decision, expected on March 17, 2025.

Losartan is an angiotensin II receptor blocker used in treating high blood pressure and is available in the market as an oral solid product.

The FDA declined to approve SCN-102 in August 2024, asking the company to provide additional information related to chemistry, manufacturing, and controls (CMC). It remains to be seen if the second time will prove a charm for SCN-102.

If approved, SCN-102 could offer enhanced convenience for patients by simplifying dosing. The product would not require compounding, has a smaller dosing volume, and can be stored at room temperature for long-term shelf life.

SCNX closed Wednesday’s (Mar.5, 2025) trading at $2.20, down 0.90%.