Biopharmaceutical company Supernus (NASDAQ:SUPN) has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for SPN-830.
The product is under review for the continuous treatment of motor fluctuations in Parkinson’s.
The FDA has requested additional information and analysis associated with the infusion device and drug product related to labeling, product quality, manufacturing, device performance as well as analysis of risk.
Notably, the regulatory body has not asked for more information related to efficacy or safety from clinical trials and the company is working towards getting the NDA application back on track for approval.
Is SUPN a Good Buy?
Despite the recent correction, SUPN stock is still up ~9.8% year-to-date and Wall Street sees a further 18.07% potential upside in the stock based on an average price target of $39 and a Moderate Buy consensus rating.
The two analysts covering Supernus stock at present remain unanimous, with two Buy ratings for the stock.