Why Supernus Pharmaceuticals (SUPN) Shares Are Falling Premarket Today - Supernus Pharmaceuticals (NASDAQ:SUPN)

Supernus Pharmaceuticals Inc SUPN received FDA's complete response letter (CRL) for the SPN-830 marketing application.
SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease (PD).
The CRL requires additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance, and risk analysis.
Related: FDA Approves Expanded Use Of Supernus' Viloxazine In Adult ADHD Patients.
In addition, the FDA mentions that approval requires inspections that could not be completed on time due to COVID-19 travel restrictions.
The CRL does not request additional efficacy and safety clinical studies.
The FDA has determined that the amendment to the Company's application in response to the CRL will be subject to a Class 2, or six-month, review timeline.
Last year, Supernus acquired Adamas Pharmaceuticals for $9.10 per share, or $450 million, to strengthen its Parkinson's disease portfolio.
Price Action: SUPN shares are down 11.4% at $29.50 during the premarket session on the last check Monday.

FDA Rejects Supernus Pharma's Minimally Invasive Parkinson's Therapy