UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 30, 2013
MannKind
Corporation
(Exact
name of registrant as specified in its charter)
|
Delaware |
000-50865 |
13-3607736 |
|
(State or other jurisdiction of incorporation or organization) |
(Commission |
(IRS Employer Identification No.) |
|
28903 North Avenue Paine Valencia, California |
91355 |
|
(Address of principal executive offices) |
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (661) 775-5300
N/A
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
| Item 8.01 | Other Events. |
On October 30, 2013, we announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.
On October 30, 2013, we issued a press release announcing the FDA's acknowledgement of the resubmission of the NDA for AFREZZA, a copy of which is attached as Exhibit 99.1 to this current report.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits. The following exhibits are filed herewith:
| 99.1 | Press Release of MannKind Corporation dated October 30, 2013, announcing FDA’s acknowledgement of MannKind’s resubmission of the NDA for AFREZZA. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MANNKIND CORPORATION |
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By: |
/s/ David Thomson, Ph.D., J.D. |
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Name: David Thomson, Ph.D., J.D. |
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Title: Corporate Vice President, |
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General Counsel and Secretary |
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Dated: |
October 30, 2013 |
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Exhibit 99.1
MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA
VALENCIA, Calif.--(BUSINESS WIRE)--October 30, 2013--MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
CONTACT:
Company Contact:
MannKind Corporation
Matthew Pfeffer
Chief
Financial Officer
661 775-5300
mpfeffer@mannkindcorp.com
or
Media
Inquiries:
MCS Healthcare Public Relations
Laura De Zutter or Jeff
Hoyak
800 477-9626
jeffh@mcspr.com
laurad@mcspr.com