INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to <18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Start Date01 Dec 2025

Sponsor / Collaborator

MannKind Corp.

[+1]

NCT06535789

/ RecruitingPhase 2/3IIT

The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes

Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.

Start Date01 May 2025

Sponsor / Collaborator

Jaeb Center For Health Research Foundation, Inc.

[+1]

NCT05904743

/ CompletedPhase 4

INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a pump without automation, and continuous glucose monitoring (CGM) 1:1 to an insulin regimen of insulin degludec plus inhaled insulin (Afrezza) and CGM or continuation of usual care. The primary outcome of the RCT is at 17 weeks. The RCT will be followed by a 13-week extension phase in which participants in both groups will use the degludec-inhaled insulin regimen.

Start Date07 Jul 2023

Sponsor / Collaborator

MannKind Corp.

[+1]

100 Clinical Results associated with Insulin Recombinant Human(MannKind)

100 Translational Medicine associated with Insulin Recombinant Human(MannKind)

100 Patents (Medical) associated with Insulin Recombinant Human(MannKind)

Literatures (Medical) associated with Insulin Recombinant Human(MannKind)

01 Sep 2025·JOURNAL OF DIABETES AND ITS COMPLICATIONS

Technosphere insulin in the treatment of Type 1 diabetes mellitus: A systematic review and meta-analysis

Review

Author: Aragão, José Aderval ; Santos, Vitória Karoline Justino Dos ; Prado, Marcelo Lucas De Lima ; Hespanhol, Larissa Calixto ; Reis, Francisco Prado ; Sant'anna Aragão, Felipe Matheus ; Sant'anna Aragão, Iapunira Catarina ; Da Silva, Gabriela Simões Noel ; De Menezes, Vanessa Lins ; Santos, Vitor Henrique Justino Dos

AIMS:

Conduct a systematic review and meta-analysis comparing Technosphere Insulin and traditional ultra-rapid insulin in T1DM.

METHODS:

Researchers conducted a systematic search on databases to identify randomized controlled trials (RCTs) comparing two insulin regimens-TI and RAI -in patients with type 1 diabetes mellitus (T1DM). The outcomes of interest included changes in HbA1c levels, body weight, and rates of overall and severe hypoglycemia.

RESULTS:

Four RCTs were included. There was no significant difference between groups on change in HbA1c (MD 0.04; 95 % CI -0.19-0.27; p = 0.74; I² = 0 %). In terms of body weight change, the TI group exhibited significantly less (MD -1.05; 95 % CI -1.63 to -0.46; p = 0.0005; I² = 0 %) compared to the RAI group. Adverse events such as overall hypoglycemia (RR -0.97; 95 % CI 0.94-1.01; p = 0.24; I² = 26 %) and severe hypoglycemia (RR 0.63; 95 % CI 0.46-0.87; p = 0.005; I² = 0 %), were significantly more frequent in the RAI group.

CONCLUSIONS:

The use of Technosphere Insulin (TI) in T1DM patients did not show a difference in HbA1c, suggesting that TI may offer advantages in weight stability and a lower incidence of hypoglycemic events compared to rapid-acting insulin (RAI).

01 Mar 2025·Diabetes Technology & Therapeutics

Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes: The INHALE-3 Extension Study

Article

Author: Diner, Jamie ; Calhoun, Peter ; Hirsch, Irl B. ; Bailey, Ryan J. ; Levister, Camilla M. ; Levy, Carol J. ; Jacobson, Christopher ; Beck, Roy W. ; Ruedy, Katrina J. ; Aleppo, Grazia ; Klein, Klara R.

Background: Postmeal hyperglycemia is difficult to avoid even with automated insulin delivery (AID) due to the delayed effect of subcutaneously administered rapid-acting insulin analogs. Inhaled technosphere insulin (TI, Afrezza®) has a more rapid onset of action with the potential to reduce the postmeal glucose rise. We evaluated the effects of a regimen of TI and degludec over 30 weeks. Methods: In total, 123 adults with type 1 diabetes (T1D) participated in a 17-week multicenter randomized controlled trial comparing a regimen of TI plus insulin degludec versus usual care, which consisted predominantly of AID or multiple daily insulin injections (MDI). Interested participants in the TI-degludec group continued this regimen for an additional 13 weeks, with no scheduled visits prior to a final visit at 30 weeks to approximate real-world care. Results: Of the 62 participants in the TI-degludec group, 58 completed the 17-week visit and 45 continued into the extension phase. Prior to the study, 44% were using AID, 9% a sensor-augmented pump without automation, and 47% MDI. Mean HbA1c was 7.6% ± 1.0% at baseline, 7.6% ± 1.0% at 17 weeks, and 7.4% ± 1.0% at 30 weeks. Mean HbA1c change from 17 weeks to 30 weeks was -0.21% (95% confidence interval -0.33% to -0.09%, P < 0.001). HbA1c was <7.0% in 21% at baseline, 30% at 17 weeks, and 42% at 30 weeks. Mean time in range 70-180 mg/dL was 52% ± 18% at baseline, 53% ± 20% at 17 weeks, and 54% ± 20% at 30 weeks. Mean percent time <54 mg/dL was 0.4% ± 0.6%, 0.4% ± 0.8%, and 0.6% ± 1.0%, respectively. Mean total daily TI dose at 30 weeks was 53 ± 31 U/day, which was about twice the total daily rapid-acting insulin analog dose of 24 ± 12 U/day at baseline prior to switching to TI. Conclusions: HbA1c levels were sustained over 30 weeks using a TI-degludec regimen after switching from AID or MDI. TI should be considered an option for people with T1D.

01 Mar 2025·Diabetes Technology & Therapeutics

A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes

Article

Author: Calhoun, Peter ; Manessis, Anastasios ; Hirsch, Irl B. ; Bailey, Ryan J. ; Church, Mei Mei ; Kudva, Yogish ; Blevins, Thomas ; Rizvi, Shafaq ; Beck, Roy W. ; Ruedy, Katrina J. ; Akturk, Halis K.

Background: Inhaled technosphere insulin (TI, Afrezza®) has a more rapid onset of action than rapid-acting insulin analogs (RAA). Methods: Forty-nine adults with type 1 diabetes (T1D) initiated a regimen of TI plus insulin degludec for 13 weeks after completing 17 weeks in the usual-care control group of a randomized trial. The initial TI dose, based on bioequivalence, was approximately two times the RAA dose being used. The primary outcome was noninferiority for daytime time-in-range (TIR) 70-180 mg/dL at 13 weeks. Results: During the preceding 17-week period (baseline), 41% of the 49 participants were using automated insulin delivery (AID), 6% a predictive-low-glucose-suspend pump, 4% a sensor-augmented pump (SAP), and 49% multiple daily injections (MDI) plus continuous glucose monitoring. Daytime TIR increased from 50% ± 17% at baseline to 55% ± 20% after 13 weeks (mean change 5.1%, 95% confidence interval [CI]: 0.3% to 9.8%, noninferiority P < 0.001, superiority P = 0.04), with an increase of 8.6% compared with baseline MDI/SAP and no change compared with baseline AID. Mean HbA1c change from baseline was -0.23% (95% CI: -0.42% to -0.04%, noninferiority P < 0.001, superiority P = 0.02), with mean change of -0.36% compared with MDI/SAP and 0.0% compared with AID. Participants meeting the HbA1c target of <7.0% increased from 14% to 31% (P = 0.02). Among baseline AID users, overnight TIR decreased by 15.6% when switched to TI-degludec, whereas among baseline MDI/SAP users, overnight TIR increased by 2.0%. Mean time <54 mg/dL was 0.5% ± 0.7% at baseline and 0.7% ± 0.8% after 13 weeks (mean change 0.2%, 95% CI: -0.1% to 0.5%). After 13 weeks, 40% of participants indicated a desire to continue using TI. Conclusions: In adults with T1D, glycemic outcomes were comparable or slightly better with TI-degludec after switching from AID or MDI. TI should be considered as an option for individuals who want an alternative to using an insulin pump or MDI for insulin delivery.

News (Medical) associated with Insulin Recombinant Human(MannKind)

05 Nov 2025

·investors.mannkindcorp.com

MannKind Corporation Reports Third Quarter 2025 Financial Results and Provides Business Update

Q3 2025 revenues of $82.1M , +17% v. Q3 2024 YTD 2025 revenues of $237.0M , +14% v. YTD 2024 Completed acquisition of scPharmaceuticals on October 7 , accelerating MannKind’s revenue growth with FUROSCIX® Program updates: sBLA for Afrezza® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule MNKD-201 IPF Phase 2 trial (INFLO) initiated and expect to enroll first patient in Q1 2026 sBLA for Afrezza® in pediatric population accepted for FDA review; PDUFA date of May 29, 2026 FUROSCIX ReadyFlow™ Autoinjector sNDA submitted to the FDA MNKD-101 NTM global Phase 3 trial (ICoN-1) achieved interim enrollment target ahead of schedule MNKD-201 IPF Phase 2 trial (INFLO) initiated and expect to enroll first patient in Q1 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. , Nov. 05, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter of 2025 and provided a business update. “The acquisition of scPharmaceuticals marks a significant expansion of our commercial capabilities and is expected to accelerate growth of our product revenues and build upon our commitment to delivering innovative, patient-centric therapies,” said Michael Castagna , PharmD, Chief Executive Officer of MannKind Corporation . “With the FDA’s acceptance for review of the Afrezza pediatric sBLA, the submission of the FUROSCIX ReadyFlow Autoinjector sNDA, and continued progress in the pipeline programs, we are executing across a diversified portfolio with significant growth opportunities ahead.” Business Update and Upcoming Milestones scPharmaceuticals Acquisition Completed the previously announced acquisition of scPharmaceuticals on October 7, 2025 Expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease FUROSCIX ReadyFlow Autoinjector supplemental New Drug Application (sNDA) filing submitted as planned in Q3 2025; review acceptance decision expected by YE 2025 Expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX (furosemide injection), an innovative therapy for edema due to chronic heart failure and chronic kidney disease Afrezza FDA accepted for review the sBLA for Afrezza® (insulin human) Inhalation Powder in the pediatric population (aged 4 – 17 years) and assigned a PDUFA date of May 29, 2026 Topline results from the full pediatric study including the safety extension to be discussed at the International Society for Pediatric and Adolescent Diabetes meeting, November 5-8, 2025 Application to update labeling regarding initial Afrezza conversion dose under FDA review; decision expected Q1 2026 Afrezza performance Q3 2025 compared to Q3 2024: $18.5 million v. $15.0 million , a 23% increase Inhaled Clofazimine MNKD-101 (nebulized) Phase 3 global clinical trial for the treatment of NTM (ICoN-1) achieved interim enrollment target of 100 patients ahead of schedule; interim analysis (study sample size re-estimation) expected mid-year 2026 MNKD-102 (DPI) advancing program following the completion of initial pre-clinical studies in NTM Nintedanib DPI (MNKD-201) Initiated IPF Phase 2 clinical trial (INFLO) and plan to enroll first patient in Q1 2026 Pre-clinical Formulating a second dry powder investigational molecule under the expanded collaboration with United Therapeutics using MannKind’s proprietary Technosphere® platform Bumetanide DPI pre-clinical study planned Corporate and Financial Appointed Dr. Ajay Ahuja as Chief Medical Officer Cash, cash equivalents and investments as of September 30, 2025 totaled $286.3 million ; In October 2025 , MannKind utilized approximately $133.2 million of available cash, cash equivalents and investments and borrowed an additional $250.0 million in delayed draw term loans to fund the acquisition of scPharmaceuticals and the related debt extinguishment Third Quarter 2025 Financial ResultsRevenues Total revenues increased $12.1 million , or 17% for the third quarter of 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to United Therapeutics Corporation (“UT”) and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand and a lower rate of sales deductions. There was a decrease in net revenue for V-Go® due to lower demand, partially offset by higher price and lower rebates on certain commercial contracts. Operating Expenses and Other Financial Highlights Research and development expenses increased by $1.1 million , or 9%, for the third quarter of 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in the ICoN-1 study for MNKD-101, and the clinical production scale up for MNKD-201. These increases were partially offset by the completion of the INHALE-3 clinical study of Afrezza and the Phase 1 study of MNKD-201 in 2024, as well as lower costs for the INHALE-1 pediatric clinical study of Afrezza, which was closed out in the second quarter of 2025. Selling, general and administrative expenses increased by $5.2 million , or 22%, for the third quarter of 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs, including the deployment of a medical science liaison team and higher Afrezza promotional costs. Additionally, general and administrative expenses included incremental costs associated with the acquisition of scPharmaceuticals which was completed in October 2025 . Gain on foreign currency transaction was $0.1 million for the third quarter 2025 compared to a loss of $2.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates. Under the Company’s Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. The Company records the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the future purchase commitments. Impairment of available-for-sale investment of $6.4 million for the three months ended September 30, 2025 was a result of the write-off of the Thirona investment. For the third quarter of 2025, the Company reported net income of $8.0 million , or $0.03 earnings per share – basic, compared to net income of $11.6 million , or $0.04 earnings per share – basic, for the same period in 2024, a decrease in net income of $3.6 million . For the third quarter of 2025, the Company reported non-GAAP net income of $22.4 million , or $0.07 earnings per share – basic, compared to non-GAAP net income of $15.4 million , or $0.06 earnings per share – basic, for the same period in 2024, an increase in non-GAAP net income of $7.0 million , or 45%. For a reconciliation of GAAP reported net income and net income per share for basic weighted average shares to these non-GAAP measures, please see Non-GAAP Measures below. Nine Months Ended September 30, 2025 Revenues Total revenues increased $28.3 million , or 14%, for the nine months ended September 30, 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to UT and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand, partially offset by a decrease in net revenue for V-Go® due to lower demand. The decrease in demand for V-Go was partially offset by higher price and lower rebates on certain commercial contracts. Operating Expenses and Other Financial Highlights Research and development expenses increased by $4.0 million , or 12%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in ICoN-1 study, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction in the third quarter of 2024, which bolstered research capabilities and capacity. These increases were partially offset by the completion of the INHALE-3 study, the Phase 1 and toxicology studies for MNKD-201 in 2024 as well as lower costs for the INHALE-1 study, which was closed out in the second quarter of 2025. Selling, general and administrative expenses increased by $15.4 million , or 22%, for the nine months ended September 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expenses as well as deploying a medical science liaison team and Afrezza promotional costs. Additionally, general and administrative expenses included incremental costs associated with the acquisition of scPharmaceuticals, which was completed in October 2025 . These increases were partially offset by a $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated the Company’s acquisition of the product. Loss on foreign currency transactions was $7.8 million for the nine months ended September 30, 2025 , compared to a loss of $0.5 million for the same period in the prior year. These non-cash changes were due to fluctuations in U.S. dollar to Euro exchange rates related to the future purchase commitments. Impairment of available-for-sale investment of $6.4 million for the nine months ended September 30, 2025 was a result of the write-off of the Thirona investment. Impairment of available-for-sale investment for the nine months ended September 30, 2024 was $1.6 million as a result of modification of the Thirona investment. For the nine months ended September 30, 2025 , the Company reported net income of $21.8 million , or $0.07 earnings per share – basic, compared to net income of $20.2 million , or $0.07 earnings per share – basic, for the same period in 2024, an increase in net income of $1.6 million . For the nine months ended September 30, 2025 , the Company reported non-GAAP net income of $58.0 million , or $0.19 earnings per share – basic, compared to non-GAAP net income of $44.8 million , or $0.16 earnings per share – basic, for the same period in 2024, an increase in non-GAAP net income of $13.2 million , or 30%. For a reconciliation of GAAP reported net income and net income per share for basic weighted average shares to these non-GAAP measures, please see Non-GAAP Measures below. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time . The webcast will be accessible via a link on MannKind’s website. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. 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 MannKind's expectations about the potential benefits from the scPharma acquisition, including diversifying and accelerating revenue growth; MannKind’s ongoing clinical trials and preclinical studies, including the Phase 3 clinical trial of MNKD-101 and the timing for patient enrollment for and an interim analysis thereof and the Phase 2 study of MNKD-201 and the expected initiation and patient enrollment timelines thereof, and the expected timing for trial results; the development of a new dry powder inhalation therapy and investigational molecule under the expanded collaboration with United Therapeutics and the planned preclinical studies thereof; the expected timing for regulatory events related to Afrezza and the FUROSCIX ReadyFlow™ Autoinjector; and other statements about future events. 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, risks and uncertainties associated with competition; commercial execution; regulatory changes impacting the pharmaceutical, medical device and healthcare industries; developing product candidates; unforeseen delays that may impact the timing of clinical trials and reporting data; the regulatory review process; manufacturing; intellectual property protection; personnel; and macroeconomic and geopolitical factors. These and other risks are detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its most recently filed Quarterly Report on Form 10- Q. 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. Tyvaso DPI is a trademark of United Therapeutics Corporation. AFREZZA, FUROSCIX, MANNKIND , SCPHARMACEUTICALS and V-GO are registered trademarks and FUROSCIX READYFLOW is a trademark of MannKind Corporation or its subsidiaries. Non-GAAP MeasuresTo supplement MannKind's condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net income and net income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this press release have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.The following table reconciles our financial measures for net income and net income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation: 1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended September 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and nine months ended September 30, 2025 totaled $33.3 million and $94.6 million , respectively, of which $3.3 million and $9.5 million , respectively were remitted to the royalty purchaser.2) Represents transaction fees incurred during the three and nine months ended September 30, 2025 associated with the acquisition of scPharma. Source: MannKind

Phase 1Phase 3Financial StatementPhase 2Acquisition

13 Oct 2025

·investors.mannkindcorp.com

MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes

If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy sBLA submission based on data from the Phase 3 INHALE-1 study PDUFA target action date of May 29, 2026 WESTLAKE VILLAGE, Calif. and DANBURY, Conn. , Oct. 13, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026 . “Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system,” said Dr. Kevin Kaiserman , M.D., Senior Vice President, Therapeutic Area Head, Endocrine Diseases at MannKind Corporation . “Inhaled insulin has been available to adults for over a decade, and we are excited about the potential of adding this treatment choice for the pediatric population.” The sBLA is based on results from the Phase 3 INHALE-1 study in children and adolescents between the ages of 4-17 who are living with either type 1 or type 2 diabetes. The 26-week open-label, randomized clinical trial evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) with basal insulin. Six-month topline results from INHALE-1 were reported in December 2024 . The submission also included safety data from the study’s 26-week extension phase in which all remaining MDI patients switched to Afrezza. Full results will be shared at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November. Afrezza was first approved by the FDA for adults (age 18+) in June 2014 and is also approved in India and Brazil . It is recognized as part of the American Diabetes Association’s Standards of Care. About AfrezzaAfrezza (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. Important Safety InformationWARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in Afrezza-treated patients with asthma and 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 StatementsThis press release contains forward-looking statements that involve risks and uncertainties, such as statements about a potential regulatory action date, the planned presentation of scientific data and the potential expanded patient population of Afrezza. 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 issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining the expanded indication as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of 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 . Source: MannKind

Phase 3Drug ApprovalNDAClinical Result

07 Oct 2025

·investors.mannkindcorp.com

MannKind Completes Acquisition of scPharmaceuticals, Accelerating Revenue Growth in Cardiometabolic Care

DANBURY, Conn. and BURLINGTON, Mass. , Oct. 07, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) successfully completed the previously announced acquisition of scPharmaceuticals Inc. The acquisition of scPharmaceuticals is expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX® (furosemide injection)- an innovative therapy for edema due to chronic heart failure and chronic kidney disease. The transaction will strengthen MannKind’s commercial and medical capabilities by integrating scPharmaceuticals’ experienced team into its existing infrastructure. MannKind is positioned as a diversified, growth-focused biopharmaceutical company with its commercial assets—Afrezza®, FUROSCIX® and V-Go® -- along with Tyvaso DPI®-related revenues, contributing to an annualized run rate of over $370 million based on Q2 2025 results. Additionally, the FUROSCIX ReadyFlow™ Autoinjector supplemental New Drug Application (sNDA) filing was submitted as planned in Q3 2025. “With the close of the acquisition, MannKind now has multiple revenue lines with strong growth potential, a deepening presence in cardiometabolic care, and a commercial infrastructure ready to support the next phase of growth,” said Michael Castagna , PharmD, Chief Executive Officer of MannKind Corporation . “This milestone accelerates our strategy to build a patient-centric company that delivers innovative therapies for chronic disease.” The strategic fit between the two organizations creates meaningful growth opportunities, combining MannKind’s endocrinology expertise and infrastructure with scPharmaceuticals’ deep cardiovascular capabilities. MannKind is positioned to expand FUROSCIX’s reach with nephrologists and cardiologists and to continue its success in chronic heart failure treatment. The potential for long-term value creation is further supported by MannKind’s late-stage pipeline, including Inhaled Clofazimine for the treatment of nontuberculous mycobacterial lung disease and nintedanib DPI for the treatment of idiopathic pulmonary fibrosis. Transaction DetailsThe acquisition was structured as a tender offer to acquire all of the outstanding shares of scPharmaceuticals common stock at a price of $5.35 per share in cash plus one non-tradable contingent value right (CVR) per share to receive certain milestone payments of up to an aggregate of $1.00 per CVR in cash, for total consideration of up to $6.35 per share in cash. The non-tradable CVR is payable upon achieving certain regulatory and net sales milestones. The tender offer expired at one minute following 11:59 p.m., Eastern Time , on October 6, 2025 . The depositary for the tender offer advised MannKind and scPharmaceuticals that scPharmaceuticals stockholders holding approximately 73.47% of the outstanding shares of scPharmaceuticals common stock had tendered their shares, satisfying the minimum condition to consummate the tender offer. In addition, notices of guaranteed delivery were delivered for shares representing approximately 10.91% of the outstanding shares of scPharmaceuticals common stock. All of the conditions of the tender offer having been satisfied, MannKind accepted for payment all such tendered shares, and following a statutory merger under Section 251(h) of the Delaware General Corporation Law on October 7, 2025 , scPharmaceuticals became a wholly owned subsidiary of MannKind . All remaining shares of scPharmaceuticals common stock that were not tendered in the tender offer were converted into the right to receive the same per share consideration as shares that were tendered in the tender offer, as described above. With the completion of the transaction, shares of scPharmaceuticals’ common stock, which traded on the Nasdaq under the symbol “SCPH,” will cease trading as of today and will no longer be listed on the Nasdaq. 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. INDICATION FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. IMPORTANT SAFETY INFORMATION FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment. Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms. The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain. Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use ( https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf) Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will”, “goal” and similar expressions. These forward-looking statements include, without limitation, statements related to the expected benefits from the acquisition of FUROSCIX, including diversifying and accelerating revenue growth, MannKind’s strategy to build a patient-centric company that delivers innovative therapies for chronic disease, and strengthening MannKind’s organization and revenue base; MannKind’s growth potential and the growth opportunities created by the acquisition of FUROSCIX; the potential for long-term value creation; the annualized revenue run rate implied by Q2 2025 results; MannKind’s late-stage pipeline including MNKD-101 and MNKD-201 and the ongoing and planned clinical trials and timing thereof; and other statements that are not historical facts. These forward-looking statements are based on MannKind’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that MannKind will not be able to retain the employees of scPharmaceuticals given the at-will nature of their employment; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; the possibility that if MannKind does not achieve the expected benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of MannKind’s shares could decline; historical revenue growth rates may not be achieved in future periods for various reasons, including competition, execution, and adverse regulatory and reimbursement changes; and other risks related to MannKind’s business detailed from time-to-time under the caption “Risk Factors” and elsewhere in MannKind’s SEC filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent quarterly and current reports filed with the SEC . MannKind undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in expectations, except as required by law. FUROSCIX is a registered trademark of scPharmaceuticals Inc., a subsidiary of MannKind Corporation . AFREZZA, V-Go, and MANNKIND are registered trademarks of MannKind Corporation . TYVASO DPI is a registered trademark of United Therapeutics Corporation. Source: MannKind

Acquisition

100 Deals associated with Insulin Recombinant Human(MannKind)

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KEGG	Wiki	ATC	Drug Bank
-	Insulin Recombinant Human(MannKind)	A10AF01 A10AD01 A10AC01	DB00030

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	United States	MannKind Corp.	27 Jun 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes, Gestational	Phase 3	United States	MannKind Corp.	01 May 2025
Glucose Intolerance	Phase 3	United States	MannKind Corp.	01 May 2025
Moderate chronic obstructive pulmonary disease	Phase 3	United States	MannKind Corp.	01 Mar 2009
Moderate chronic obstructive pulmonary disease	Phase 3	Russia	MannKind Corp.	01 Mar 2009
Moderate chronic obstructive pulmonary disease	Phase 3	Ukraine	MannKind Corp.	01 Mar 2009
Asthma	Phase 3	United States	MannKind Corp.	01 Jun 2006
Asthma	Phase 3	Argentina	MannKind Corp.	01 Jun 2006
Asthma	Phase 3	Brazil	MannKind Corp.	01 Jun 2006
Asthma	Phase 3	Canada	MannKind Corp.	01 Jun 2006
Asthma	Phase 3	Czechia	MannKind Corp.	01 Jun 2006

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2025	Phase 3	Diabetes Mellitus, Type 2	216	Technosphere insulin (TI)	kxxcjmuqih(wruqvlydvd): Difference = -0.417 (95.0% CI, -0.74 to -0.09), P-Value = 0.0124 View more	Positive	20 Jun 2025
				Placebo
NCT04974528 (INHALE-1, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	230	Afrezza	noquzqfjzs(arzucrtive) = clxweukdjv bplglcfnaw (eskyutbwza )	Non-inferior	16 Dec 2024
				Multiple Daily Injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin	noquzqfjzs(arzucrtive) = cahenntojb bplglcfnaw (eskyutbwza )
NCT05904743 (Pubmed) Manual	Phase 4	Diabetes Mellitus, Type 1	123	Inhaled Technosphere insulin (TI)Technosphere insulin (TI) plus insulin degludec	wyphaxztnc(vbssurmyfo) = sehgleozzh gzzuvjseww (jegormjcbe, 1.06) View more	Positive	06 Dec 2024
				Inhaled Insulin (Usual Care (UC))	wyphaxztnc(vbssurmyfo) = aqkpykdtzf gzzuvjseww (jegormjcbe, 0.77) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	pqdnaxqllw(figaktpcib) = mucjmffwhv pojyluxsjx (egduxfavkg, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	pqdnaxqllw(figaktpcib) = sqqlkfiffp pojyluxsjx (egduxfavkg, 0.29) View more
NCT03324776 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	20	Afrezza Inhalant Product	nhpawkokcz(ydxoldtwfb) = dzhssrhelo vqvvljxomd (lbqgkgafxm, 0.247) View more	-	26 Jun 2024
NCT05904743 (INHALE-3, Company_Website) Manual	Phase 4	Diabetes Mellitus, Type 1	123	AfrezzaAfrezza (insulin human) Inhalation Powder	hixyireqkw(omziaxffbo) = vwmyuakuyx kdjxhggzge (khpddolvlm ) Met View more	Similar	22 Jun 2024
				Usual care (MDI, AID, or pump without automation)	hixyireqkw(omziaxffbo) = aaczihfnfm kdjxhggzge (khpddolvlm ) Met View more
NCT04849845 (DOS, CTgov)	Phase 4	Diabetes Mellitus, Type 1 \| Diabetes Mellitus, Type 2	20	insulin (Afrezza Dose 1)	henztjsklh(dtmxjaufro) = tcboeynkpa gufxtljkmn (hnarujlwja, 3.3) View more	-	18 Sep 2023
				insulin (Afrezza Dose 2)	henztjsklh(dtmxjaufro) = jfvwtnpfav gufxtljkmn (hnarujlwja, 2.5) View more
NCT02527265 (Pubmed \| Diabetes Ther)	Phase 2	Diabetes Mellitus, Type 1	27	Technosphere Insulin	czrqbtwxks(rzleazrhha) = ncfaloceks ocyclyccwb (rtycblogjy ) View more	-	18 Jan 2023
NCT03143816 (STAT \| not provided, CTgov)	Phase 4	Diabetes Mellitus, Type 1	60	insulin aspart (Insulin Aspart ( Novolog) -Control Arm)	pgvayytmez(snrpesjdyw) = cxoglsdwbm iqfbunqfwu (fhnrojxetu, 1.8) View more	-	22 Feb 2022
				Technosphere insulin (Technosphere Insulin (TI, Afrezza) -Treatment Arm)	pgvayytmez(snrpesjdyw) = fxmadsedfo iqfbunqfwu (fhnrojxetu, 2.2) View more
NCT02527265 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	30	insulin+Afrezza (Technosphere Insulin) (Afrezza Cohort 1 (Ages 13-17))	rljcxcwrcb(bbxcazcsoq) = zuysdbhkqs xrtovxbplk (xvjilshogw, 5.77) View more	-	06 Apr 2021
				insulin+Afrezza (Technosphere Insulin) (Afrezza Cohort 2 (Ages 8-12))	rljcxcwrcb(bbxcazcsoq) = tqgvtsdjsy xrtovxbplk (xvjilshogw, 31.4) View more

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