Welcome to our dedicated page for Mannkind news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind stock.
MannKind Corporation (Nasdaq: MNKD) generates frequent news across product, clinical, regulatory, and corporate fronts as it advances therapies for cardiometabolic and orphan lung diseases. News coverage for MNKD often centers on its commercial products Afrezza, FUROSCIX, V-Go, and Tyvaso DPI–related collaborations, as well as updates on its inhaled and subcutaneous pipeline.
Investors and healthcare observers following MNKD news can expect announcements on U.S. Food and Drug Administration (FDA) milestones, including supplemental Biologics License Applications and supplemental New Drug Applications. Recent examples include FDA acceptance for review of an sBLA for Afrezza in children and adolescents with type 1 or type 2 diabetes, and acceptance of an sNDA for the FUROSCIX ReadyFlow Autoinjector for edema in adults with chronic heart failure or chronic kidney disease.
MannKind’s news flow also covers clinical trial progress and portfolio decisions in orphan lung diseases. The company has reported on initiation of nintedanib DPI (MNKD-201) studies for idiopathic pulmonary fibrosis, as well as the discontinuation of the Phase 3 ICoN-1 trial of nebulized clofazimine (MNKD-101) for refractory nontuberculous mycobacterial lung disease following a futility analysis. Updates on pre-clinical programs such as bumetanide DPI and MNKD-102 are also featured in its communications.
Corporate and financial news items include quarterly earnings results, revenue breakdowns across royalties, collaborations, and product sales, and strategic transactions. A notable example is MannKind’s acquisition of scPharmaceuticals, which brought FUROSCIX fully into its portfolio and expanded its presence in cardiometabolic care. The company also issues releases about investor conference presentations and community initiatives, such as the Centennial Al Mann Scholarship for students living with diabetes.
This news page aggregates these developments so readers can review regulatory decisions, trial outcomes, business combinations, and financial updates related to MannKind in one place.
MannKind Corporation (Nasdaq: MNKD) is set to release its 2021 fourth quarter and full year financial results on February 24, 2022, at 5:00 p.m. Eastern Time. The call will feature CEO Michael Castagna and CFO Steven Binder, discussing key financial outcomes and corporate updates. MannKind focuses on inhaled therapeutic products, notably the FDA-approved Afrezza®, an ultra rapid-acting mealtime insulin available nationwide in the U.S. and Brazil through partner Biomm SA.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in a Fireside Chat at the SVB Leerink 2022 Global Healthcare Conference on February 17, 2022, at 1:00 PM (ET). Interested parties can access the webcast through the Company’s website. MannKind is known for developing inhaled therapeutic products, including Afrezza®, an FDA-approved inhaled insulin that is available in the U.S. and Brazil. The webcast will be available for 14 days post-event.
MannKind Corporation (Nasdaq: MNKD) has announced that its CEO, Michael Castagna, PharmD, will present at the H.C. Wainwright Bioconnect Conference. The presentation will be available on demand starting January 10, 2022. Interested individuals can find the webcast link in the Events & Presentations section of the company’s website, where it will remain accessible for 14 days post-event.
The company specializes in inhaled therapeutic products for endocrine and orphan lung diseases, with its flagship product being Afrezza, the only inhaled ultra rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced the purchase of an additional convertible note from Thirona Bio, enhancing their collaboration initiated in June 2021 focused on FBM5712, a TGF-β inhibitor for pulmonary fibrosis. MannKind is advancing its inhaled formulation, MNKD-501, into a nonclinical PD study, with results expected in Q2 2022. CEO Michael Castagna has joined Thirona's board. Positive early signals from initial studies indicate potential efficacy, which could lead to further development and commercialization rights for treating fibrotic lung diseases.
MannKind Corporation (Nasdaq: MNKD) will participate in the Lytham Partners Winter 2021 Investor Conference from December 13-16, 2021. CEO Michael Castagna will host a webcasted Fireside Chat on December 13 at 11:00 AM ET to discuss the company's vision for 2022. Additionally, Castagna and CFO Steven B. Binder will hold 1x1 virtual investor meetings. The Fireside Chat will be available on the company's website and archived for replay. MannKind focuses on inhaled therapeutic products for endocrine and orphan lung diseases, with its lead product, Afrezza, being the only inhaled ultra-rapid acting insulin available in the U.S.
MannKind Corporation (MNKD) reported a 45% increase in total revenues to $22.2 million for Q3 2021, driven by Afrezza net revenue of $9.8 million, up 34% year-over-year. Collaboration revenue also rose 54% to $12.5 million. Gross profit increased 61% to $5.9 million, leading to a gross margin improvement to 61% from 51%. Despite these gains, the net loss was $4.4 million or $0.02 per share, down from $11.3 million in the prior year. Cash equivalents stood at $181.1 million as of September 30, 2021.
MannKind Corporation (Nasdaq: MNKD) announced the completion of a sale-leaseback transaction that generated $102.25 million in non-dilutive gross proceeds on November 8, 2021. This deal involves the sale of 263,900 square feet of manufacturing space in Danbury, Conn., while MannKind retains operational control of its facilities. The company manufactures Afrezza® (inhaled insulin) and Tyvaso DPI™ (inhaled treprostinil) at this location. MannKind also signed a 20-year lease with renewal options, allowing continued operations without the burden of ownership.
MannKind Corporation (Nasdaq: MNKD) is set to present promising findings regarding its Technosphere® Insulin (TI) at the 21st Annual Diabetes Technology Meeting on November 11. This feasibility study highlights that a TI dose—approximately double the standard mealtime subcutaneous injection—significantly reduced postprandial glucose excursions without causing severe hypoglycemia. Specifically, the maximum mean postprandial glucose dropped from 234 to 186 mg/dL, demonstrating a 50 mg/dL improvement at 120 minutes.
MannKind Corporation (Nasdaq:MNKD) will announce its third quarter financial results on November 9, 2021, at 5:00 PM ET. CEO Michael Castagna and CFO Steven B. Binder will discuss the financial performance and corporate updates during a conference call. The call will be available for live listening on the company’s website, with a replay accessible for 14 days. MannKind specializes in developing inhaled therapeutic products, including Afrezza, the only FDA-approved inhaled ultra rapid-acting mealtime insulin in the U.S. More information can be found on their corporate site.
MannKind Corporation (Nasdaq: MNKD) announced that the FDA issued a complete response to United Therapeutics regarding the New Drug Application (NDA) for Tyvaso DPI to treat pulmonary arterial hypertension and interstitial lung disease. The rejection was due to one open inspection issue at a third-party testing center, with no deficiencies found in MannKind's Connecticut facility. MannKind continues to build pre-launch inventory and plans to support United Therapeutics in securing NDA approval in the future.