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Biotech Stocks Facing FDA Decision In October 2022

Supernus Pharmaceuticals
Supernus Pharmaceuticals

Supernus Pharmaceuticals Inc.’s (SUPN) SPN-830, an apomorphine infusion pump, proposed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease, awaits the FDA decision in early October.

The U.S. regulatory agency had refused to review the original New Drug Application for SPN-830 in November 2020, indicating that the filing was not sufficiently complete to permit a substantive review then.

Addressing the concerns raised by the FDA, the company resubmitted the NDA in December 2021, which was accepted for review.

SPN-830, if approved by the FDA, would offer patients a less invasive and a convenient option in the form of a continuous subcutaneous infusion of Apomorphine.

Apomorphine, marketed under brand name Apokyn, given as a shot under the skin, is indicated for the acute, intermittent treatment of hypomobility, "off" episodes associated with advanced Parkinson’s disease.

SUPN closed Thursday’s (Sep.29,2022) trading at $33.28, down 0.39%