ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for discussion Register to chat with like-minded investors on our interactive forums.

MNKD MannKind Corporation

4.3216
-0.0584 (-1.33%)
03 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
MannKind Corporation NASDAQ:MNKD NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.0584 -1.33% 4.3216 4.36 4.48 4.49 4.34 4.45 1,836,337 23:25:37

Current Report Filing (8-k)

02/04/2014 11:02am

Edgar (US Regulatory)


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 1, 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 1, 2014, we announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDA) voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.

Although the EMDA provides recommendations to the FDA, the FDA makes the final decision with respect to approval of a drug. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 15, 2014 for its review of our New Drug Application (NDA) for AFREZZA®.

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 1, 2014, announcing FDA Advisory Committee's recommendation to approve MannKind's Investigational Drug to Treat Diabetes


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 1, 2014
(Date)
  /s/   DAVID THOMSON, PH.D., J.D.
David Thomson, Ph.D., J.D.
Corporate Vice President, General Counsel and Secretary

1 Year MannKind Chart

1 Year MannKind Chart

1 Month MannKind Chart

1 Month MannKind Chart

Your Recent History

Delayed Upgrade Clock