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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
05/21/201510:30:00James S. Shannon Rejoins MannKind's Board of Directors
05/21/201508:59:02MannKind, Front and Center: The Best Product Doesnât Always E...
05/19/201511:36:02Forget MannKind Stock's Price: Here's What You Need to Focus...
05/17/201510:04:024 Reasons Why MannKind Could Succeed Where Pfizer Failed
05/15/201516:02:03Why MannKind Stock Got New Life Breathed Into It Today
05/15/201515:48:11Why MannKind Stock Got New Life Breathed Into It Today
05/11/201517:30:37Quarterly Report (10-q)
05/08/201515:07:59Amended Statement of Ownership (sc 13g/a)
05/08/201512:01:33Why Shares in MannKind Corp. Are Tumbling
05/08/201506:05:16Current Report Filing (8-k)
05/07/201518:48:29MannKind Corporation Reports 2015 First Quarter Financial Results
05/07/201511:59:02The Best Company for Investing in the Diabetes Market
05/07/201508:17:02Here's Why MannKind Corporation Was Clobbered in April
05/06/201517:00:00MannKind to Present at Bank of America Merrill Lynch 2015 Healthcare...
05/03/201509:19:02In Case You Missed It, This New Study Suggests America Is a Nation...
04/30/201517:00:00MannKind Corporation to Hold 2015 First Quarter Financial Results...
04/29/201509:09:02MannKind's Future: More than Just Afrezza?
04/28/201517:42:57Statement of Changes in Beneficial Ownership (4)
04/27/201512:31:32Current Report Filing (8-k)
04/27/201509:00:00MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R...

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