MAP Pharmaceuticals (MAPP) Surges as FDA Accepts NDA Resubmission for LEVADEX

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Shares of MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) are sharply higher Friday following news late Wednesday that the FDA accepted its NDA resubmission for LEVADEX, its inhaled migraine drug for the potential acute treatment of migraine in adults.

The FDA has classified the resubmission as a complete, Class 2 response to the FDA’s March 26, 2012 action letter and has set a goal date of April 15, 2013 under the Prescription Drug User Fee Act.

Analysts at Deustche Bank said that while it took longer than expected, the news will likely be viewed as a positive by the investment community, given recent share weakness reflecting recent investor concerns that the FDA may reject MAP’s resubmission, potentially creating a further delay.

This development is in-line with Deustche Bank’s expectation and positions MAP for a potential mid-2013 launch although they said it’s likely that the third party manufacturing facilities will require a re-inspection prior to final approval.

Shares of MAPP last traded at $15.20, up 18.4 percent.