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) April 7, 2014
MannKind Corporation
(Exact name of registrant as specified in its charter)
Delaware | 000-50865 | 13-3607736 |
(State or other jurisdiction of incorporation) |
(Commission File Number) | (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:
[ ] | 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 April 7, 2014, we announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by us in response to the FDA's requests.
A copy of the press release 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 April 7, 2014, updating the status of the New Drug Application 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.
MannKind Corporation
(Registrant) |
||
April 7, 2014
(Date) |
/s/ DAVID THOMSON, PH.D., J.D.
David Thomson, Ph.D., J.D. Corporate Vice President, General Counsel and Secretary |
EXHIBIT 99.1
VALENCIA, Calif., April 7, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.
About AFREZZA®
AFREZZA® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90-150 minutes for injected regular human insulin.
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®, is under review by the FDA. MannKind regularly posts copies of its press releases as well as additional information about MannKind on its website www.mannkindcorp.com. Interested persons can subscribe on the 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: Investors: Matthew J. Pfeffer Chief Financial Officer MannKind Corporation mpfeffer@mannkindcorp.com (661) 775-5300 Media: Laura de Zutter MCS Healthcare Public Relations laurad@mcspr.com (908) 234-9900 Jeff Hoyak MCS Healthcare Public Relations jeffh@mcspr.com (908) 884-6753