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FDA clears MannKind (NASDAQ: MNKD) Afrezza use in children 6 and older

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

MannKind Corporation reported that the U.S. Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. This expands Afrezza’s use beyond adults into the pediatric diabetes population.

The FDA also stated that the supplemental biologics license application for this pediatric indication has fulfilled the last remaining postmarketing requirement for Afrezza from its original June 27, 2014 approval. This means all originally required follow-up obligations for Afrezza have now been completed.

Positive

  • FDA pediatric approval for Afrezza extends use to children and adolescents aged 6 and older with type 1 and type 2 diabetes, opening access to a new treatment population.
  • Postmarketing requirements completed as the FDA indicated the pediatric supplemental biologics license application fulfills the last remaining obligation from Afrezza’s original June 27, 2014 approval.

Negative

  • None.

Insights

FDA pediatric approval broadens Afrezza’s reach and completes its original postmarketing obligations.

The FDA approval of Afrezza for children and adolescents aged 6 and older with type 1 and type 2 diabetes gives MannKind access to the pediatric insulin market. The company highlights that more than 350,000 U.S. children and adolescents live with diabetes, indicating a sizable potential patient pool.

The FDA’s statement that the supplemental biologics license application fulfills the last remaining postmarketing requirement from the June 27, 2014 approval removes a key regulatory follow-up obligation. Future disclosures in company filings may provide more detail on uptake in the pediatric segment and any related commercial impact.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Pediatric age range 6 years and older Children and adolescents eligible for Afrezza use
U.S. pediatric diabetes population More than 350,000 children and adolescents United States children and adolescents living with diabetes
Original Afrezza approval date June 27, 2014 Date of original FDA approval referenced in filing
Afrezza medical
"FDA approved Afrezza (insulin human) Inhalation Powder for use in children and adolescents"
supplemental biologics license application regulatory
"The FDA also stated that the supplemental biologics license application for the pediatric indication has fulfilled"
A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.
postmarketing requirement regulatory
"has fulfilled the last remaining postmarketing requirement for Afrezza as set forth in the original June 27, 2014 approval"
type 1 diabetes medical
"children and adolescents aged 6 and older living with type 1 and type 2 diabetes"
An autoimmune condition in which the pancreas stops producing insulin, a hormone that lets the body use sugar for energy; without insulin people must manage blood sugar with injections, pumps, or other therapies. For investors, it matters because the lifelong need for medicines, devices, and monitoring creates steady demand, influences healthcare spending and reimbursement decisions, and drives clinical trials and regulatory activity in the diabetes treatment market.
type 2 diabetes medical
"children and adolescents aged 6 and older living with type 1 and type 2 diabetes"
Type 2 diabetes is a chronic condition where the body struggles to control blood sugar levels because it becomes less responsive to insulin, a hormone that helps regulate sugar in the blood. It matters to investors because it can lead to increased healthcare costs, affect workforce productivity, and influence the performance of companies in the healthcare and pharmaceutical sectors. Managing or preventing the condition has significant implications for public health and economic stability.
pediatric indication medical
"the supplemental biologics license application for the pediatric indication has fulfilled the last remaining postmarketing requirement"
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Understanding 8-K Material Events →
false000089946000008994602026-05-292026-05-29

 

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): May 29, 2026

 

 

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.)

 

 

 

 

 

1 Casper Street

 

Danbury, Connecticut

 

06810

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (818) 661-5000

 

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))

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


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.01 per share

 

MNKD

 

The Nasdaq Stock Market LLC

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

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. ☐

 

Item 8.01 Other Events.

On May 29, 2026, we announced that the U.S. Food and Drug Administration (FDA) approved Afrezza®(insulin human) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. In the United States, more than 350,000 children and adolescents are living with diabetes, the majority of whom have type 1 diabetes and require lifelong insulin therapy.

The FDA also stated that the supplemental biologics license application for the pediatric indication has fulfilled the last remaining postmarketing requirement for Afrezza as set forth in the original June 27, 2014 approval letter.

SIGNATURES

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: June 2, 2026

By:

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

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

Executive Vice President, General Counsel and Secretary

 

Source: View Original Filing on SEC EDGAR

FAQ

What did the FDA approve for MannKind (MNKD) in this 8-K?

The FDA approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 and older with type 1 and type 2 diabetes. This extends Afrezza beyond adult use and formally adds a pediatric indication to its label in the United States.

Which patients are now eligible to use Afrezza according to MannKind (MNKD)?

Afrezza is now approved for children and adolescents aged 6 and older living with type 1 or type 2 diabetes. These younger patients join adults as eligible users of the inhaled insulin therapy, broadening the overall population who can receive this treatment option.

How many U.S. children could be affected by MannKind’s Afrezza pediatric approval?

MannKind notes that more than 350,000 children and adolescents in the United States are living with diabetes. Most have type 1 diabetes and require lifelong insulin therapy, so pediatric Afrezza approval targets a substantial potential treatment population.

What regulatory milestone did MannKind (MNKD) complete with this Afrezza filing?

The FDA stated that the supplemental biologics license application for Afrezza’s pediatric indication fulfills the last remaining postmarketing requirement. This requirement stemmed from Afrezza’s original June 27, 2014 approval, meaning all initial follow-up obligations are now satisfied.

What SEC form did MannKind use to report the Afrezza pediatric approval?

MannKind used a Form 8-K under Item 8.01, which covers other events. This form allows a company to inform investors about significant developments such as FDA approvals that may be important to understanding its business and future prospects.

Filing Exhibits & Attachments

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