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Why Supernus Pharmaceuticals Is Up 24 Percent Monday (SUPN)

Test tubes and other recipients in chemistry labShares of Surpernus Pharmaceuticals (NASDAQ: SUPN) are up 24 percent Monday morning after the company announced final FDA approval for Trokendi XR, a drug for the treatment of epilepsy. The company expects the product to be in pharmacies within the next couple of weeks.

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“We are very excited about the approval of Trokendi XR and its upcoming launch. This is excellent news for Supernus, its shareholders, and patients with epilepsy. We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients,” said Jack Khattar, Chief Executive Officer, President and Director of Supernus.

Interestingly, this is official news but it’s not unexpected. Thanks to BioRunUp for posting this reminder:



The press release, date June 10, 2013, announces that the FDA tentatively approved Trokendi XR. At the time, the company said this:

“As expected and as previously communicated, most recently during our May 13, 2013 quarterly earnings call, since this approval was granted before the June 22, 2013 date of expiration of the Topamax(R) data exclusivity, this approval came in the form of a tentative approval. We will now submit the “Request for Final Approval” letter to the FDA based on which we expect to receive Final Approval and then launch our product, as anticipated, in the third quarter of 2013,” said Jack Khattar, Chief Executive Officer, President and Director of Supernus.”


Company Profile:

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The Company has one marketed product for epilepsy, Oxtellar XR(TM) (extended-release oxcarbazepine), and one approved product for epilepsy, Trokendi XR(TM) (extended-release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

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Disclosure: At the time of this writing, the author had no position in the company mentioned.

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