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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
03/20/201708:44:35Statement of Changes in Beneficial Ownership (4)
03/20/201708:43:07Initial Statement of Beneficial Ownership (3)
03/17/201716:34:47Current Report Filing (8-k)
03/16/201717:03:06Annual Report (10-k)
03/16/201716:17:17Current Report Filing (8-k)
03/16/201716:01:00MannKind Corporation Reports 2016 Fourth Quarter and Full Year...
03/08/201709:00:00MannKind Corporation and Charles Mattocks Announce “REVERSED”-America’s First...
03/07/201709:00:00MannKind Corporation Announces Upcoming Events
03/02/201708:02:12Current Report Filing (8-k)
02/23/201716:55:52Current Report Filing (8-k)
02/21/201709:00:00MannKind Receives $16.7 Million From Sale of Valencia Property 
02/13/201708:32:04Proxy Statement (definitive) (def 14a)
02/01/201716:58:14Proxy Statement - Notice of Shareholders Meeting (preliminary...
02/01/201709:30:48Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:29:47Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:29:19Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:28:40Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:28:13Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:27:32Annual Statement of Changes in Beneficial Ownership (5)
02/01/201709:00:00MannKind Announces Launch of New Titration Pack and Field Force...

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