Supernus Pharmaceuticals Inc

+0.55 (+2.58%)
Regulatory, Earnings Announcements

Supernus Provides Regulatory Updates For SPN-812 And SPN-830

Published: 11/09/2020 23:41 GMT
Supernus Pharmaceuticals Inc (SUPN) - Supernus Provides Regulatory Updates for Spn-812 and Spn-830.
Supernus - U.S. FDA Has Issued Complete Response Letter Regarding NDA for Spn-812 for Treatment of Adhd in Pediatric Patients 6 to 17 Years of Age.
Supernus - FDA Issued Crl for Spn-812 to Indicate Review Cycle for Application is Complete, Application Not Ready for Approval in Present Form.
Supernus Pharmaceuticals - No Clinical Safety Or Efficacy Issues Were Identified During Review for Spn-812.
Supernus - Got Refusal to File Letter From FDA Regarding NDA for Spn-830 for Continuous Treatment of Motor Fluctuations in Parkinson's Disease.
Supernus Pharmaceuticals - in Refusal to File Letter, FDA Requested Certain Documents & Reports to Be Submitted in Support of Application for Spn-830.
Supernus Pharmaceuticals - Plans to Seek Guidance From FDA, Including a Type a Meeting, to Discuss Contents of Rtf Letter.
Supernus Pharmaceuticals - Reiterates Full Year 2020 Net Product Sales and Research and Development Expenses Guidance.
Revenue is expected to be $145.85 Million
Adjusted EPS is expected to be $0.53

Next Quarter Revenue Guidance is expected to be $133.2 Million
Next Quarter EPS Guidance is expected to be $0.30

More details on our Analysts Page.