Company Description
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company focused on transforming chronic disease care through patient-centric therapies. According to company disclosures, MannKind concentrates on cardiometabolic and orphan lung diseases, developing and commercializing treatments that address serious unmet medical needs in areas such as diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.
Core focus and therapeutic areas
MannKind describes its mission as improving chronic disease management for people living with complex, long-term conditions. Its work spans:
- Diabetes – through inhaled insulin therapy designed to improve glycemic control in adults with diabetes mellitus.
- Pulmonary hypertension – via collaborations that generate royalty and collaboration revenues tied to dry powder inhaled therapies.
- Heart failure and chronic kidney disease – with therapies for edema (congestion, fluid overload, or hypervolemia) in adult and pediatric patients meeting specified criteria.
- Orphan lung diseases – including development programs for conditions such as nontuberculous mycobacterial (NTM) lung disease and idiopathic pulmonary fibrosis (IPF).
Commercial products and revenue drivers
Based on recent press releases and SEC filings, MannKind’s commercial and revenue-generating activities include:
- Afrezza (insulin human) Inhalation Powder – a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. It is delivered as a dry powder formulation of human insulin from a small portable inhaler and is recognized in the American Diabetes Association’s Standards of Care.
- FUROSCIX (furosemide injection), 80 mg/10 mL for subcutaneous use – indicated for the treatment of edema (congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease, including nephrotic syndrome. A supplemental approval expanded the indication to pediatric patients weighing at least 43 kg.
- FUROSCIX On-body Infusor – an FDA-approved on-body infusor presentation of FUROSCIX for adult patients with chronic heart failure and chronic kidney disease, with post-marketing pediatric expansion as described in company communications.
- V-Go – referenced in MannKind’s financial results as a commercial product contributing to revenues.
- Tyvaso DPI–related revenues – MannKind reports royalties and collaboration revenues related to Tyvaso DPI, reflecting its role in supplying product and technology under a license and collaboration agreement with United Therapeutics.
In its third quarter 2025 financial update, MannKind highlighted multiple revenue lines: Afrezza, FUROSCIX, V-Go and Tyvaso DPI–related royalties, as well as collaborations and services revenue from partners such as United Therapeutics and Amphastar.
Drug–device combinations and Technosphere platform
MannKind emphasizes its deep expertise in drug–device combinations, aiming to deliver therapies that fit into daily life. The company’s proprietary Technosphere platform underpins several inhaled products and pipeline candidates. Under an amended global license and collaboration agreement with United Therapeutics, MannKind formulates investigational molecules using Technosphere and manufactures clinical trial materials, while United Therapeutics conducts preclinical and clinical development.
Pipeline and development programs
Recent MannKind communications outline a diversified pipeline across inhaled and injectable modalities:
- Afrezza pediatric sBLA – the U.S. FDA has accepted a supplemental Biologics License Application seeking approval of Afrezza in children and adolescents aged 4–17 years with type 1 or type 2 diabetes, with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.
- Afrezza label update – an FDA review is underway for a label update related to initial dose conversion when switching from subcutaneous rapid-acting insulin to Afrezza.
- FUROSCIX ReadyFlow Autoinjector (SCP-111) – a supplemental New Drug Application (sNDA) has been accepted for review by the FDA for an autoinjector designed to deliver subcutaneous furosemide injection 80 mg/mL in under 10 seconds as an investigational alternative to the FUROSCIX On-body Infusor for adult patients with chronic heart failure or chronic kidney disease.
- Nintedanib DPI (MNKD-201) – a dry powder inhalation formulation in clinical development for idiopathic pulmonary fibrosis, with a Phase 2 trial (INFLO) initiated and patients enrolling into studies described as INFLO-1 and INFLO-2.
- Clofazimine programs – MNKD-101, a nebulized clofazimine inhalation suspension for refractory NTM lung disease, was evaluated in the Phase 3 ICoN-1 trial. Following a futility assessment showing no sputum culture conversions among the first 46 participants, MannKind discontinued this trial. The company reports that MNKD-102, a dry powder inhalation formulation of clofazimine, remains under consideration for future clinical advancement and is progressing toward Phase 1 development.
- Bumetanide DPI (MNKD-701) – a dry powder inhalation program in pre-clinical development.
- Additional Technosphere-based product with United Therapeutics – under a first amendment to the global license and collaboration agreement, MannKind will formulate an additional investigational molecule using Technosphere and supply clinical trial materials, with eligibility for development milestones and royalties on potential future net sales.
Acquisition of scPharmaceuticals and cardiometabolic expansion
In October 2025, MannKind completed the acquisition of scPharmaceuticals Inc., which became a wholly owned subsidiary following a tender offer and subsequent merger described in the company’s Form 8-K filings. The acquisition brings FUROSCIX fully into MannKind’s commercial portfolio and is described by the company as diversifying and accelerating revenue growth in cardiometabolic care. MannKind notes that combining its endocrinology-focused infrastructure with scPharmaceuticals’ cardiovascular capabilities enhances its presence in chronic heart failure and chronic kidney disease–related fluid overload.
Collaborations and revenue mix
MannKind’s reported revenue streams include:
- Royalties – primarily from increased net sales of Tyvaso DPI under the United Therapeutics collaboration.
- Collaborations and services – including product sold to United Therapeutics and co-promotion activities with Amphastar.
- Commercial product sales – Afrezza, V-Go, and, following the scPharmaceuticals acquisition, FUROSCIX.
SEC filings describe how changes in royalties, collaboration revenue, and product sales affect total revenues over time, while also detailing research and development and selling, general and administrative expenses associated with clinical programs and commercial expansion.
Research, development, and clinical strategy
MannKind’s R&D activities, as outlined in its financial updates and 8-K filings, include:
- Clinical production scale-up for inhaled pipeline assets such as MNKD-201.
- Global registrational and Phase 2 trials in orphan lung diseases, including NTM lung disease and idiopathic pulmonary fibrosis.
- Pre-clinical work on additional dry powder inhalation therapies, including bumetanide DPI and MNKD-102.
The company also reports adjustments to its clinical portfolio, such as discontinuing the nebulized clofazimine ICoN-1 trial based on a futility determination, while using the findings to inform future development of the dry powder formulation.
Corporate profile and stock information
MannKind Corporation is incorporated in Delaware and its common stock trades on The Nasdaq Stock Market LLC under the ticker symbol MNKD, as disclosed in multiple Form 8-K filings. The company reports principal executive offices in Danbury, Connecticut, and references operations and corporate activities in locations including Danbury, Connecticut; Westlake Village, California; and Burlington, Massachusetts in its press releases.
Founder's legacy and patient-centered initiatives
MannKind traces its origins to the vision of founder Alfred E. Mann, whose work in medical devices and diabetes care helped lead to the development of Afrezza. In 2025, the company announced the Centennial Al Mann Scholarship, a program developed with Alfred E. Mann Charities and The Diabetes Link to support young adults living with diabetes who are pursuing higher education in life sciences. This initiative reflects MannKind’s stated commitment to both medical innovation and community support within the diabetes population.
Position within the pharmaceutical preparation manufacturing sector
Within the pharmaceutical preparation manufacturing industry, MannKind is characterized by its focus on inhaled and subcutaneous drug–device combinations for chronic cardiometabolic and orphan lung conditions. Its business model, as described in public disclosures, combines proprietary formulation technology, internal commercial capabilities for select products, and strategic collaborations with larger partners for certain inhaled therapies. For investors and observers, MNKD represents exposure to a portfolio that spans approved products, late-stage regulatory submissions, and earlier-stage inhaled pipeline programs targeting serious chronic diseases.