Supernus Pharma whiffs for now on NDTAs for SPN-812, SPN-830

• Supernus Pharmaceuticals (NASDAQ:SUPN) says it received a complete response letter regarding its new drug application for SPN-812 for the treatment of ADHD in pediatric patients 6-17 years old.
• The FDA says the application is not ready for approval in its present form, citing Superna's in-house laboratory that conducts analytical testing, which recently moved to a new location; no clinical safety or efficacy issues were identified.
• Superna says it will discuss with the FDA that the application does not rely solely on this facility for product release, and will discuss steps required to re-submit the NDA for SPN-812.
• The company also received a refusal to file letter from the FDA regarding its NDA for SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease, as the agency requested certain documents and reports in support of the application.
• The company also raised its operating income forecast for the full year, now guiding for $155M-$170M compared with $145M-$160M previously, while maintaining its outlook for full-year net product sales at $500M-$525M.
• Supernus last week reported better than expected Q3 earnings and revenues.
• https://seekingalpha.com/news/3634131-supernus-pharma-whiffs-for-now-on-ndas-for-spnminus-812-spnminus-830