MannKind Corporation reports developments across its biopharmaceutical business in cardiometabolic and orphan lung diseases. Company updates center on commercial products such as Afrezza, an inhaled insulin for diabetes, and Furoscix, a furosemide injection for fluid overload in heart failure and chronic kidney disease, as well as financial results, product demand, launch infrastructure and capital-structure actions.
MannKind news also covers dry powder inhalation programs and drug-device combinations, including work using its Technosphere platform. Recurring topics include Afrezza clinical and real-world data, Furoscix device and regulatory updates, Nintedanib DPI for idiopathic pulmonary fibrosis, ralinepag DPI collaboration activity with United Therapeutics, and other pipeline decisions affecting inhaled therapies.
MannKind will present the 17-week endpoint results of the INHALE-3 study at the ADA's 84th Scientific Sessions on June 22, 2024. The study compares Afrezza, an inhaled insulin, with multiple daily injections and insulin pumps in adults with Type 1 diabetes. The presentation, featuring Dr. Irl B. Hirsh and moderated by Dr. Roy W. Beck, will include various insights into the efficacy, safety, and quality of life outcomes of Afrezza. This event marks the largest post-market clinical trial for Afrezza in the past decade. Full results will be available later this year.
MannKind (Nasdaq: MNKD) announced a non-cash transaction with Pulmatrix, obtaining a license for Pulmatrix's iSPERSE™ technology and an upgraded Boston-area R&D facility. In exchange, Pulmatrix will receive MannKind's Cricket® inhaler for DHE delivery. The iSPERSE technology will be used for clofazimine, NTM, and insulin, and for certain endocrine and lung diseases. This move aims to strengthen MannKind's capacity for formulation and asset development, leveraging both companies' technological advancements. The transaction is expected to finalize in July 2024.
Pulmatrix announced a series of transactions with MannKind involving a cross-license agreement and transfer of laboratory assets. Pulmatrix's iSPERSE™ technology will be licensed to MannKind, while Pulmatrix gains access to MannKind's Cricket® inhalation device for its PUR3100 formulation, aimed at treating acute migraine. Additionally, MannKind will assume Pulmatrix's lease for its Bedford, Mass. R&D facility, extending Pulmatrix's cash runway into 2026. The agreement, expected to close in July 2024, also includes a master service arrangement for MannKind to provide future dry powder drug formulation services to Pulmatrix.
MannKind reported strong financial results for the first quarter of 2024, with total revenues reaching $66 million, marking a 63% increase from the previous year. The company also achieved a net income of $11 million, with $304 million in cash and investments as of March 31, 2024. MannKind received Fast Track designation and IND clearance for MNKD-101, showcasing progress in their clinical development. Moreover, the company highlighted revenue growth, margin improvements, and advancements in their product pipeline, positioning them for a successful year ahead.
MannKind (MNKD) has received Fast Track designation from the FDA for Clofazimine Inhalation Suspension for the treatment of NTM lung disease. This designation aims to speed up the review process for important medicines addressing unmet medical needs. The company is optimistic about the ICoN-1 study and the potential benefits for patients with NTM. The drug has also received orphan drug and QIDP designations, potentially providing up to 12 years of market exclusivity.
MannKind (Nasdaq: MNKD) will host a conference call to discuss its 2024 first quarter financial results on May 8, 2024. Interested parties can listen live on the Company's website.
MannKind (Nasdaq: MNKD) has announced the initiation of a Phase 1 study for nintedanib DPI (MNKD-201) targeting pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). This study will assess safety, tolerability, and pharmacokinetics in healthy volunteers, with enrollment expected to commence in June 2024. The company aims to provide potential treatment options for patients with serious lung diseases, following their ongoing Phase 3 study of Clofazimine Inhalation Suspension for nontuberculous mycobacterial (NTM) lung diseases.
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