MannKind Announces First Patient Enrolled in INHALE-1ST Pediatric Study Evaluating Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes (T1D)

Rhea-AI Summary

MannKind (NASDAQ: MNKD) announced first patient enrollment in INHALE-1ST, a single-arm U.S. study evaluating initiation of Afrezza inhaled insulin with once-daily basal insulin in youth aged 10 to <18 years newly diagnosed with type 1 diabetes.

About 100 patients across ~10 sites will be followed 13 weeks (plus optional extension to 26 weeks); primary endpoint is ≥70% time-in-range (70–180 mg/dL) by CGM. An Afrezza pediatric sBLA is under FDA review with a PDUFA date of May 29, 2026.

Positive

• First patient enrolled in INHALE-1ST evaluating Afrezza in pediatric T1D
• Planned ~100-patient, multicenter study across about 10 U.S. sites
• Primary endpoint targets clinically relevant CGM time-in-range (TIR ≥70%)
• sBLA for pediatric Afrezza accepted with PDUFA date May 29, 2026

Negative

• Study is single-arm, limiting randomized comparative evidence
• Afrezza contraindicated in chronic lung disease due to acute bronchospasm risk
• Not recommended for patients who smoke or recently stopped smoking
• FDA pediatric approval remains uncertain until PDUFA decision on May 29, 2026

Key Figures

Patient age range: 10 to <18 years Clinical sites: about 10 sites Planned enrollment: approximately 100 patients +5 more

8 metrics

Patient age range 10 to <18 years INHALE-1ST pediatric Afrezza study population

Clinical sites about 10 sites INHALE-1ST study locations across the United States

Planned enrollment approximately 100 patients Target enrollment for INHALE-1ST pediatric trial

Main phase duration 13 weeks Primary treatment period in INHALE-1ST single-arm study

Extension phase duration up to 26 weeks Optional extension using Afrezza plus basal insulin

Primary endpoint TIR threshold ≥70% TIR Time in range 70–180 mg/dL over 14 days before week-13 visit

PDUFA date May 29, 2026 Afrezza pediatric sBLA FDA target action date

Insulin therapy history 100+ years Period without a needle-free insulin option for pediatric patients

Market Reality Check

Price: $5.78 Vol: Volume 3,011,654 vs 20-da...

normal vol

$5.78 Last Close

Volume Volume 3,011,654 vs 20-day average 4,141,233 (relative volume 0.73x) ahead of this news. normal

Technical Shares at $5.78 are trading above the 200-day MA of $4.89, and about 11.21% below the 52-week high of $6.51.

Peers on Argus

MNKD gained 4.9% with multiple biotech peers also up (e.g., SRPT +5.17%, ARDX +2...

MNKD gained 4.9% with multiple biotech peers also up (e.g., SRPT +5.17%, ARDX +2.38%, VCEL +1.4%), suggesting broader positive sector tone alongside this company-specific pediatric Afrezza update.

Historical Context

5 past events · Latest: Jan 26 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 26	Afrezza label update	Positive	+2.2%	FDA approved updated Afrezza label with starting dose conversion guidance.
Jan 08	Business outlook	Positive	+2.7%	Outlined 2026 growth drivers including record Q4 revenue and multiple PDUFA dates.
Dec 23	FUROSCIX updates	Positive	-1.0%	Reported FUROSCIX pediatric approval and new patents but shares fell modestly.
Dec 01	ReadyFlow sNDA	Positive	+1.5%	FDA accepted sNDA for FUROSCIX ReadyFlow with July 26, 2026 PDUFA date.
Nov 11	Conference appearance	Neutral	+0.0%	Jefferies conference presentation announcement with no immediate price reaction.

Pattern Detected

Recent regulatory and pipeline updates have generally seen positive price alignment, with one divergence on favorable FUROSCIX news.

Recent Company History

Over the last few months, MannKind reported several regulatory and clinical milestones. On Nov 5, 2025, Q3 2025 results showed total revenue of $82.13M and positive net income, followed by an 8-K on the same date for its earnings press release. Subsequent filings covered the scPharmaceuticals merger and FUROSCIX ReadyFlow sNDA with a July 26, 2026 PDUFA date. On Jan 26, 2026, the FDA approved an updated Afrezza label. Today’s INHALE-1ST pediatric enrollment builds on this Afrezza-focused regulatory and clinical momentum.

Market Pulse Summary

This announcement details first-patient enrollment in the INHALE-1ST pediatric Afrezza study and hig...

Analysis

This announcement details first-patient enrollment in the INHALE-1ST pediatric Afrezza study and highlights an upcoming Afrezza pediatric PDUFA date of May 29, 2026. It follows recent FDA actions on Afrezza labeling and progress for FUROSCIX ReadyFlow. Investors may watch enrollment pace, 13-week time-in-range outcomes, and the optional 26-week extension, alongside regulatory milestones across the portfolio, to gauge how pediatric use could complement MannKind’s existing adult diabetes and cardiorenal franchises.

Key Terms

type 1 diabetes, pdufa

2 terms

type 1 diabetes medical

"youth aged 10 to <18 years recently diagnosed with type 1 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.

pdufa regulatory

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

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

AI-generated analysis. Not financial advice.

Study to assess safety, efficacy and treatment experience of starting inhaled insulin in youth aged 10 to <18 years recently diagnosed with T1D

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 09, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced that the first patient has been enrolled in INHALE-1^ST, a clinical study evaluating the initiation of Afrezza^® (insulin human) Inhalation Powder shortly after a type 1 diabetes diagnosis in pediatric patients.

“We are excited to kick off the INHALE-1^ST study and begin enrolling patients,” said Roy W. Beck, M.D., Ph.D., Medical Director of the Jaeb Center for Health Research, which is leading the study. “Having lived through one of my children developing type 1 diabetes, I know first-hand how overwhelming it is to find out that your child has been diagnosed with diabetes and has to start giving injections of insulin multiple times a day. The study will help evaluate whether replacing most of the injections with inhalations of insulin may lessen that burden for children and their families as they adjust to managing a lifelong disease.”

INHALE-1^ST is designed to assess the safety and efficacy of Afrezza used in combination with subcutaneously injected basal insulin once-daily in youth aged 10 to <18 years newly diagnosed with type 1 diabetes. The study will examine clinical outcomes as well as participant and caregiver satisfaction with use of Afrezza for management of mealtime glucose early in the course of treatment.

The first patient was enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado, one of about 10 clinical sites participating in the study of approximately 100 patients across the United States.

“Many of the innovations that transformed diabetes care—such as continuous glucose monitors (CGMs) and insulin pumps—proved their full value and impact once they became available to pediatric patients,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With nearly a decade of safety and real-world adult experience behind Afrezza, INHALE-1^ST gives us an important opportunity to assess use earlier in the treatment journey for youth at the time of diagnosis so patients can potentially improve management of their mealtime glucose.”

The 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 (CGM)-who measured time in range (TIR) 70-180 mg/dL ≥70% during 14 days prior to the 13-week visit. More information on the INHALE-1^ST study is available at: ClinicalTrials.gov (NCT07224321).

Afrezza Pediatric Indication: FDA Review in Progress
In October 2025, the FDA accepted for review a supplemental Biologics License Application (sBLA) for Afrezza^® Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy.

INDICATION AND IMPORTANT SAFETY INFORMATION WITH WARNINGS

Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

• Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
• Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
• Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV₁) to identify potential lung disease in all patients.
  
  

Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.

Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety.

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the potential for inhaled insulin to lessen the burden of adjusting to a chronic disease. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s 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, the risk that continued testing of a drug may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.

MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com

FAQ

What is the goal of MannKind's INHALE-1ST study for Afrezza (MNKD)?

The study aims to assess safety, efficacy and treatment experience of starting inhaled Afrezza in newly diagnosed youth. According to MannKind, the trial will measure CGM time-in-range and participant/caregiver satisfaction over a 13-week main phase with optional extension to 26 weeks.

How many patients and sites are planned for the INHALE-1ST pediatric trial (MNKD)?

INHALE-1ST plans approximately 100 participants across about 10 U.S. clinical sites. According to MannKind, the first patient was enrolled at the Barbara Davis Center and additional sites will enroll youth aged 10 to under 18 years.

What is the primary endpoint and duration of the INHALE-1ST study for Afrezza (MNKD)?

Primary endpoint is percent of participants with CGM time-in-range 70–180 mg/dL ≥70% during 14 days before week 13. According to MannKind, the main phase lasts 13 weeks with an optional extension up to 26 weeks.

When will the FDA decide on Afrezza's pediatric indication (MNKD)?

The FDA has a PDUFA target action date of May 29, 2026, for Afrezza's pediatric sBLA. According to MannKind, this review could determine whether Afrezza becomes an approved needle-free insulin option for children and adolescents.

What safety limitations should investors note about Afrezza (MNKD) in pediatric use?

Afrezza carries a bronchospasm risk and is contraindicated in chronic lung disease patients. According to MannKind, spirometry is required before use and Afrezza is not recommended for current or recent smokers; common adverse reactions include hypoglycemia and cough.