Supernus Pharma Pops 25% on Tentative FDA Approval
Shares of Supernus Pharmaceuticals (NASDAQ: SUPN) are seeing increased strength during Friday's trading session after the company received tentative approval from the U.S. Food and Drug Administration.
Supernus Pharmaceuticals announced that it received a tentative approval letter from the FDA for Trokendi XR, a once-daily extended release formulation of topiramate.
The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. Our initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
Friday, shares of Supernus Pharmaceuticals were trading up 23 percent at $11.90 per share.
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