MAP Pharma Falls as Much as 35% on CRL

Shares of MAP Pharmaceuticals MAPP are seeing much weakness during Tuesday's pre-market trading session after the company received a complete response letter from the FDA yesterday after the close on its LEVADEX drug. In the Complete Response letter, the FDA requested that MAP Pharma addressed issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA. The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The Company continues to pursue approval of LEVADEX for the acute treatment of migraine in adults. MAP Pharmaceuticals plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter. Shares fell as much as 35% in early pre-market trade on Tuesday. However, Canaccord Genuity published a research report on MAP Pharmaceuticals commenting and defending the company's current cash balance. In the report, Canaccord writes, "The issues relating to CMC will likely be the primary focus, with the complete review of the inhaler usability information that was requested late to continue. Management will likely have a better understanding post meeting with FDA. Cash balance is large and should be enough to carry through approval – per the Q3 filing (10-K not yet filed), MAPP had $112 million in cash ($3.50 per share) with another $75 million in potential milestones from Allergan linked to launch and labelling." Currently, shares of MAP Pharma are trading about 19% lower at $13.82 per share.