SUPN - Supernus gains on resubmission of marketing application for ADHD therapy

Following a ~4.4% gain yesterday, Supernus Pharmaceuticals ([[SUPN]] +2.1%) is back in the positive territory today after it announced the resubmission of the New Drug Application (“NDA”) for SPN-812 in the treatment of ADHD in pediatric patients.In November, the company disclosed the receipt of a complete response letter from the FDA for the experimental therapy in which the regulator mainly cited Supernus’ in-house laboratory for analytical testing.With the facility now moved to a new location, the company has addressed the regulatory concerns in the resubmission.Meanwhile, depending on the FDA decision, the company plans to submit a supplemental NDA in H2 2021 for SPN-812 in adults.In January, Supernus announced a Phase 3 trial for SPN-812 in adults with ADHD met the primary endpoint.

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Supernus gains on resubmission of marketing application for ADHD therapy