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MannKind Says FDA Review Of Afrezza To Take Four More Weeks

DOW JONES NEWSWIRES MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of its new drug application for its inhaled-insulin product for diabetics will require four additional weeks. The biopharmaceutical company, which has no products on the market currently, had been expecting FDA approval of Afrezza by Wednesday. MannKind has been hoping to succeed where larger drug makers have failed. In the mid-2000s, several companies were seeking to bring an inhaled formulation of insulin to market as an alternative to injections. The FDA initially had sought more information from MannKind in March about how the available data support the clinical utility of Afrezza in the marketplace, though the company at the time still planned a 2011 launch of the product. The FDA accepted its resubmission in July. The company also was dealt a setback in November when a former senior manager accused the drug developer of unlawful practices in its conduct of clinical trials, an accusation the company denies. Shares closed Monday at $7.97 and were inactive premarket. The stock is still down 9% this year, though it has recovered some of its losses since the FDA's action in March. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com

Stock News for Mannkind (MNKD)
DateTimeHeadline
06/12/201615:00:00MannKind Announces Late-Breaking Data Reinforcing Faster Onset...
06/10/201609:00:00MannKind Announces Collaboration with JDRF
05/24/201616:27:18Current Report Filing (8-k)
05/18/201608:02:16Statement of Changes in Beneficial Ownership (4)
05/18/201608:00:42Initial Statement of Beneficial Ownership (3)
05/10/201609:14:46Prospectus Filed Pursuant to Rule 424(b)(5) (424b5)
05/10/201608:40:25Current Report Filing (8-k)
05/09/201618:24:19MannKind Announces Pricing of Registered Direct Public Offering...
05/09/201616:46:04Current Report Filing (8-k)
05/09/201616:42:06Quarterly Report (10-q)
05/09/201616:00:00MannKind Corporation Reports 2016 First Quarter Financial Results
05/05/201617:00:00MannKind Corporation to Present at the Bank of America Merrill...
05/04/201617:33:47Current Report Filing (8-k)
05/04/201617:28:33Prospectus Filed Pursuant to Rule 424(b)(5) (424b5)
05/02/201617:00:00MannKind Corporation to Hold 2016 First Quarter Financial Results...
04/28/201606:01:26Notice of Effectiveness (effect)
04/26/201616:59:34Current Report Filing (8-k)
04/21/201616:24:04Proxy Statement (definitive) (def 14a)
04/19/201613:27:07Analyst Call Rescheduled to April 26, 2016
04/19/201609:00:00MannKind Expands Commercial Capabilities With Two New Hires

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