false 0000899460 0000899460 2022-01-18 2022-01-18


Washington, D.C. 20549



Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported):  January 18, 2022  

MannKind Corporation
(Exact Name of Registrant as Specified in Charter)





(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(I.R.S. Employer Identification Number)


1 Casper Street, Danbury, Connecticut 06810

(Address of Principal Executive Offices) (Zip Code)

(818) 661-5000
(Registrant's telephone number, including area code)

(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. of Form 8-K):


  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))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:


Title of each class





Name of each exchange on which registered

Common Stock, par value $0.01 per share




The Nasdaq Stock Market LLC




Item 8.01. Other Events.

On October 18, 2021, United Therapeutics Corporation (“UT”) issued a press release disclosing that it had received a Complete Response from the U.S. Food and Drug Administration (the “FDA”) concerning UT’s new drug application (“NDA”) for Tyvaso DPI™.  On December 27, 2021, UT disclosed that it had resubmitted the NDA to the FDA. On January 18, 2022, UT disclosed that the FDA has acknowledged acceptance of the NDA for review as a class 1 response with a user fee goal date in February 2022.

TYVASO DPI is a trademark of United Therapeutics Corporation.


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









Date: January 18, 2022



/s/ David Thomson, Ph.D., J.D.




David Thomson, Ph.D., J.D.




Corporate Vice President, General Counsel and Secretary