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Biotech Stocks Facing FDA Decision In April 2024

Supernus Pharmaceuticals
Supernus Pharmaceuticals

Supernus Pharmaceuticals Inc.’s (SUPN) SPN-830, which failed to pass the regulatory muster in October 2022, is back at the FDA altar again, with a decision expected on April 5, 2024.

SPN-830, an apomorphine infusion pump, is proposed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.

The FDA had declined to approve SPN-830 in October 2022, requiring the company to provide additional information and analysis related to SPN-830.

Addressing the FDA’s questions raised in October 2022, the company resubmitted its New Drug Application for SPN-830 last October, and now awaits the FDA decision on the aforementioned date.

If approved, SPN-830 would offer patients a less invasive treatment option for PD patients.

SUPN is currently (Mar.28, 2024) trading at $33.61, down 0.39%.