MannKind Corporation 's ( MNKD ) loss of 14 cents per share in the first quarter of 2014 was wider than the Zacks Consensus Estimate by a penny but narrower than the year-ago loss by a penny.
MannKind did not generate any revenue in the first quarter of 2014, as in the year-ago quarter.Quarter in Detail
Research and development (R&D) expenses remained flat at $26.2 million in the reported quarter. MannKind is primarily focusing on the development of its lead pipeline candidate, Afrezza, which is currently under review in the U.S. Afrezza, an inhaled insulin, is being developed for the treatment of type I and type II diabetes.
General and administrative expenses increased approximately 51.7% in the reported quarter to $15.2 million. The increase was primarily attributable to higher non-cash stock-based compensation expenses and consulting and legal fees.Afrezza Update
A final decision from the FDA on the approval of Afrezza is expected by Jul 15, 2014. MannKind is currently working closely with the U.S. regulatory body regarding the review of the diabetes candidate.
Last month, MannKind's shares skyrocketed 73.9% after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of the approval of Afrezza. The panel voted 13-1 recommending the approval of Afrezza to improve glycemic control in adults with type I diabetes. The panel unanimously recommended (14-0) the approval of Afrezza in the U.S to improve glycemic control in adults with type II diabetes.
However, the FDA had stated in its briefing document prior to the panel vote that although the candidate demonstrated statistically superior HbA1c reduction compared to placebo, it failed to demonstrate a higher HbA1c reduction compared to Novo Nordisk
's ( NVO
) NovoLog in type I diabetes patients. Moreover, the FDA was concerned with the observed safety findings on Afrezza including pulmonary safety, lung cancer risk and disease specific safety issues.
We note that Afrezza has been through a rough patch in the past. The FDA had previously issued two complete response letters for Afrezza. We expect investor focus to remain on the approval of Afrezza. Marketing approval of Afrezza will come as a huge boost for the company.
MannKind, a biopharma stock, presently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the same sector include Alexion Pharmaceuticals, Inc.
) and Ariad Pharmaceuticals Inc.
). Both stocks hold a Zacks Rank #2 (Buy).
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