MannKind Corporation

MNKD

Held by 4 specialist biotech funds

High Convergence

4 funds opened new positions. Next phase3 readout (Inhaled Technosphere Insulin): Jul 2025. Short interest: 9.0% of float.

BiotechnologyCEO: Michael E. CastagnaIPO: 2004Website ↗

MannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes. It also promotes Thyquidity to adult and pediatric endocrinologists, and other healthcare providers for the treatment of hypothyroidism. The company has a license and collaboration agreement with United Therapeutics Corporation. It also has an agreement with NRx Pharmaceuticals to develop a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human vasoactive intestinal peptide to help protect cells against inflammatory conditions. MannKind Corporation was incorporated in 1991 and is headquartered in Westlake Village, California.

Catalysts

Phase 2Q1 2003MKC1106-MTMelanoma (Skin)NCT00033228

Primary: The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.Enrollment:19/19Sites: 5TREATMENT

Phase 2PositiveQ2 2004Technosphere InsulinType 2 Diabetes MellitusNCT00511719

Primary: Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin (crossover approx every 2 weeks for up to 10 weeks)Enrollment:13/13RANDOMIZED, TREATMENT

Phase 2PositiveQ2 2004Technosphere/InsulinDiabetes Mellitus, Type 2NCT00419302

Primary: Glycemic response to a meal challengeEnrollment:Target 16Sites: 1RANDOMIZED, TREATMENT

Phase 2Q4 2004Technosphere InsulinType 2 Diabetes MellitusNCT00511602

Primary: HbA1c change from baseline (week 2) to end of treatment (week 12) (12 weeks)Enrollment:123/123RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2005Technosphere InsulinType 2 Diabetes MellitusNCT00511732

Primary: HbA1c change from baseline (week 6) to end of treatment (week 17) (measured from week 6 (baseline) to week 17)Enrollment:227/227RANDOMIZED, DOUBLE, TREATMENT

Phase 2PositiveQ4 2005Technosphere InsulinDiabetes Mellitus, Type 1NCT00539396

Primary: Change in blood glucose following a standard meal (0-300 minutes)Enrollment:Target 110RANDOMIZED, TREATMENT

Phase 3PositiveQ3 2006Technosphere InsulinDiabetes Type 2NCT00539890

Primary: Mean change in HbA1c from baseline to treatment week 24 (24 weeks)0Sites: 33RANDOMIZED, TREATMENT

Phase 2Q3 2006Technosphere Insulin Inhalation PowderDiabetes Type 2NCT00934414

Primary: To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability (15 to 52 days)Enrollment:24/24Sites: 1NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ4 2007Technosphere InsulinDiabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, AsthmaNCT00332826

Primary: The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment periodEnrollment:3/3Sites: 78RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2008Technosphere InsulinDiabetes Mellitus, Type 2NCT00332488

Primary: Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue (Baseline to Week 12)Enrollment:547/547Sites: 120RANDOMIZED, TREATMENT

Phase 2PositiveQ2 2008Technosphere® Insulin Inhalation Powder and MedTone™ InhalerType 2 Diabetes MellitusNCT00754624

Primary: Annual Rate of Change in FEV1 From Baseline to End of Study (Baseline to 48 months)Enrollment:229/229Sites: 40NON_RANDOMIZED, TREATMENT

Phase 3PositiveQ3 2008Technosphere InsulinDiabetes, Type INCT00308308

Primary: Compare the Mean Change From Baseline to Week 52 in HbA1c (Baseline to Week 52)Enrollment:589/589Sites: 129RANDOMIZED, TREATMENT

Phase 3PositiveQ3 2008Technosphere® Insulin Inhalation PowderDiabetes Type 2NCT00309244

Primary: Change From Baseline in HbA1c to Week 52 (Baseline to Week 52)Enrollment:677/677Sites: 151RANDOMIZED, PREVENTION

Phase 3PositiveQ3 2008Technosphere® Insulin Inhalation PowderDiabetes, Type 1, Diabetes, Type 2NCT00308737

Primary: Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care (Baseline to Month 24)Enrollment:2,053/2,053Sites: 176RANDOMIZED, TREATMENT

Phase 2PositiveQ4 2008Technosphere® Insulin Inhalation PowderDiabetes Mellitus: Type 1NCT00662857

Primary: Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360 (0 to 360 minutes post-dose)Enrollment:29/29Sites: 2RANDOMIZED, TREATMENT

Phase 2PositiveQ1 2009Technosphere InsulinDiabetes Mellitus, Type 2NCT00570687

Primary: Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge (0-480 minutes)Enrollment:30/30Sites: 1RANDOMIZED, TREATMENT

Phase 3NegativeQ4 2009Technosphere InsulinDiabetes, Type 1NCT00700622

Primary: Change From Baseline in HbA1c to Week 16 (Baseline to Week 16)Enrollment:130/130Sites: 22RANDOMIZED, TREATMENT

Phase 2NegativeQ1 2011TI Inhalation Powder and Humalog (Amendment 1)Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1NCT00747006

Primary: Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects) (0 to 240 minutes)Enrollment:18/18Sites: 1RANDOMIZED, TREATMENT

Phase 3NegativeQ3 2011Technosphere® Insulin Inhalation PowderType 2 DiabetesNCT01196104

Primary: Change in HbA1c (%) From Baseline to Week 16 (Baseline to Week 16)Enrollment:39/39Sites: 29RANDOMIZED, TREATMENT

Phase 2NegativeQ3 2011MKC1106-MTStage III Melanoma, Stage IV MelanomaNCT01026051

Primary: To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria) (12 Months)Enrollment:5/5Sites: 4NA, TREATMENT

Phase 3Q2 2013Technosphere® Insulin with MedTone C InhalerType 1 Diabetes MellitusNCT01445951

Primary: Change From Baseline to Week 24 in HbA1c (Baseline to Week 24)Enrollment:518/518Sites: 90RANDOMIZED, TREATMENT

Phase 3PositiveQ2 2013Technosphere® InsulinType 2 DiabetesNCT01451398

Primary: Change From Baseline to Week 24 in HbA1c (Baseline to Week 24)Enrollment:353/353Sites: 76RANDOMIZED, DOUBLE, TREATMENT

Phase 3NegativeQ4 2014Technosphere® InsulinType 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Moderate Chronic Obstructive Pulmonary DiseaseNCT00642616

Primary: Change in Post-bronchodilator FEV1 From Baseline to Week 52 (52 Weeks)Enrollment:34/34Sites: 21RANDOMIZED, TREATMENT

Phase 2Q1 2020AfrezzaType 1 Diabetes MellitusNCT02527265

Primary: Insulin Maximum Observed Concentration (Cmax) (250 minutes post-dose)Enrollment:30/30Sites: 13NA, TREATMENT

Phase 3Q4 2024AfrezzaDiabetes Mellitus, Type 1, Diabetes Mellitus, Type 2NCT04974528

Phase 3Q3 2025Inhaled Technosphere InsulinDiabetes, Gestational, Pregnancy Complications, Glucose Metabolism DisordersNCT06535789

Phase 3NegativeQ4 2025Clofazimine Inhalation SuspensionMAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, NontuberculousNCT06418711

Phase 2Q1 2027Technosphere InsulinType 1 Diabetes MellitusNCT07224321

Phase 2Q1 2028Nintedanib Dry Powder InhalationIdiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)NCT07679893

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