FDA drops MannKind (NASDAQ: MNKD) Afrezza pulmonary malignancy trial demand

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

MannKind Corporation reports a key regulatory change and a pediatric clinical update for its inhaled insulin Afrezza. The FDA has released the company from a postmarketing requirement to run a five-year, randomized trial in 8,000-10,000 adults with type 2 diabetes to assess pulmonary malignancy risk versus standard care. The only remaining postmarketing requirement for Afrezza is a study of efficacy and safety in pediatric patients.

The FDA is reviewing a supplemental Biologics License Application for Afrezza use in children and adolescents aged 4-17 with a PDUFA target action date of May 29, 2026. MannKind is also enrolling the INHALE-1st study in youth aged 10-17 with newly diagnosed type 1 diabetes, following up to 100 participants across 10 sites for 13 weeks, with an optional 26-week extension, and expects data in late 2027.

Positive

FDA lifts major postmarketing trial requirement: The agency released MannKind from a five-year, randomized trial in 8,000-10,000 adults with type 2 diabetes to assess Afrezza’s pulmonary malignancy risk versus standard care, significantly reducing long-term clinical and cost obligations tied to Afrezza.

Negative

None.

Insights

FDA’s release from a large Afrezza safety trial removes a major obligation.

The FDA has lifted a five-year, 8,000-10,000 patient postmarketing trial requirement comparing Afrezza’s pulmonary malignancy risk to standard care. This substantially reduces Afrezza’s long-term clinical and financial burden while leaving only a pediatric postmarketing study obligation.

The agency continues to review a pediatric Afrezza label expansion for ages 4-17, with a PDUFA target action date of May 29, 2026. MannKind is also running the INHALE-1st pediatric type 1 diabetes trial, targeting up to 100 participants, with data expected in late 2027. Future regulatory decisions on the pediatric label and study outcomes will shape Afrezza’s potential reach in younger patients.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Released postmarketing trial size: 8,000-10,000 patients Postmarketing trial duration: five-year trial Pediatric sBLA age range: 4-17 years +5 more

8 metrics

Released postmarketing trial size 8,000-10,000 patients Adult type 2 diabetes pulmonary malignancy risk trial requirement lifted by FDA

Postmarketing trial duration five-year trial Length of Afrezza pulmonary malignancy postmarketing study no longer required

Pediatric sBLA age range 4-17 years Afrezza supplemental BLA in children and adolescents with diabetes

PDUFA target date May 29, 2026 FDA action date for pediatric Afrezza supplemental BLA

INHALE-1st enrollment target up to 100 participants Youth aged 10-17 with newly diagnosed type 1 diabetes

INHALE-1st clinical sites 10 clinical sites Trial of Afrezza plus basal insulin in youth

Main study duration 13 weeks INHALE-1st main phase follow-up

Extension phase duration up to 26 weeks Optional extension for participants continuing Afrezza plus basal insulin

Key Terms

Biologics License Application, postmarketing requirement, PDUFA target action date, continuous glucose meter, +1 more

5 terms

Biologics License Application regulatory

"In connection with the approval of the Biologics License Application (“BLA”) for Afrezza in June 2014"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

postmarketing requirement regulatory

"the FDA required us to conduct a five-year, randomized, controlled trial... On May 27, 2026, the FDA informed us that we were released from this postmarketing requirement"

PDUFA target action date regulatory

"with a PDUFA target action date of May 29, 2026"

The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.

continuous glucose meter medical

"The primary endpoint is the percentage of participants with a continuous glucose meter who measured time in range"

time in range medical

"time in range of 70-180 mg/dL ≥70% during 14 days prior to the 13-week visit"

Understanding 8-K Material Events →

05/28/2026 - 08:37 AM

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 27, 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.

Regulatory Update

In connection with the approval of the Biologics License Application (“BLA”) for Afrezza in June 2014, the U.S. Food and Drug Administration (“FDA”) required us to conduct a five-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the risk of pulmonary malignancy observed with Afrezza to that observed in a standard of care control group.

On May 27, 2026, the FDA informed us that we were released from this postmarketing requirement.

The only remaining postmarketing requirement for Afrezza is an assessment of its efficacy and safety in pediatric patients. In October 2025, the FDA accepted for review a supplemental BLA for Afrezza in children and adolescents between the ages of 4-17 who are living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026.

Clinical Update

INHALE-1st: An additional eight sites have been activated to enroll participants into INHALE-1st, a study to evaluate the efficacy and safety of Afrezza plus basal insulin for youth aged 10-17 with newly-diagnosed type 1 diabetes. Up to 100 participants are expected to be enrolled in this study across 10 clinical sites. This single-arm, multi-center, clinical study will follow participants for 13 weeks during the main phase followed by an optional extension phase for participants continuing to use Afrezza in combination with basal insulin for up to 26 weeks. The primary endpoint is the percentage of participants with a continuous glucose meter who measured time in range of 70-180 mg/dL ≥70% during 14 days prior to the 13-week visit. Data from this study is expected to be available in late 2027.

Forward-Looking Statements

Statements in this report that are not statements of historical fact are forward-looking statements. Words such as “plans,” “expects,” “intend,” “will,” “anticipate,” “potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding the future development of Afrezza; expectations regarding our ongoing and planned clinical trials, including the expected number of patients to be enrolled and clinical sites for and timing for data readouts for INHALE-1st, and the expected PDUFA target action date for Afrezza in children and adolescents. These forward-looking statements are based upon our current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trial enrollment and progression, and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; and other risks detailed in our filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 6, 2026. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this report.

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: May 28, 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 key FDA decision did MannKind (MNKD) announce about Afrezza?

The FDA released MannKind from a five-year, randomized postmarketing trial in 8,000-10,000 adults with type 2 diabetes to compare Afrezza’s pulmonary malignancy risk to standard care. This leaves only a pediatric postmarketing requirement for Afrezza.

What postmarketing requirements remain for Afrezza according to MannKind’s update?

The only remaining postmarketing requirement for Afrezza is a study assessing its efficacy and safety in pediatric patients. The large adult pulmonary malignancy risk trial in 8,000-10,000 type 2 diabetes patients is no longer required by the FDA.

What is the status of MannKind’s pediatric Afrezza filing with the FDA?

The FDA accepted a supplemental Biologics License Application for Afrezza in children and adolescents aged 4-17 with type 1 or type 2 diabetes. The filing carries a PDUFA target action date of May 29, 2026, guiding the expected timing of the FDA’s decision.

What is the design of MannKind’s INHALE-1st study in youth with type 1 diabetes?

INHALE-1st is a single-arm, multicenter trial of Afrezza plus basal insulin in youth aged 10-17 with newly diagnosed type 1 diabetes. It plans to enroll up to 100 participants across 10 sites for a 13-week main phase with an optional 26-week extension.

What is the primary endpoint in MannKind’s INHALE-1st Afrezza trial?

The primary endpoint is the percentage of participants with continuous glucose monitoring who achieve at least 70% time in range (70-180 mg/dL) during the 14 days before the 13-week visit. This endpoint focuses on day-to-day glucose control in youth using Afrezza plus basal insulin.

When does MannKind expect data from the INHALE-1st Afrezza study?

MannKind expects data from the INHALE-1st study to be available in late 2027. The trial follows youth with newly diagnosed type 1 diabetes for 13 weeks in the main phase, with an optional 26-week extension for those continuing Afrezza plus basal insulin.

Filing Exhibits & Attachments

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