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 (Nasdaq: MNKD), specializing in inhaled therapeutic products for endocrine and orphan lung diseases, has announced its participation in three major investor conferences during Q1 2025. The company's leadership, including CEO Michael Castagna and CFO Chris Prentiss, will present at:
- Oppenheimer 35th Annual Healthcare Life Sciences Conference (virtual) - February 11, 11:20 a.m. ET
- Leerink Partners 2025 Global Healthcare Conference in Miami - March 11, 8:40 a.m. ET
- Barclays 27th Annual Global Healthcare Conference in Miami - March 12, 1:30 p.m. ET
Live audio webcasts will be accessible through MannKind's investor relations website, with recordings available for approximately 90 days post-conference.
MannKind (MNKD) has appointed Dominic Marasco, RPh, as President of its Endocrine Business Unit, effective January 6, 2025. Marasco, who brings over 25 years of experience in biopharma and biotech sectors, will report to CEO Michael Castagna.
Marasco's most recent role was Executive President and Chief Commercial Officer at Envision Pharma Group, where he led technology and AI business units. His prior experience includes leadership positions at BioAgilytix Labs, Syneos Health, Amgen, Sandoz Biopharmaceuticals, and Eli Lilly. He holds a degree from the Philadelphia College of Pharmacy and completed Harvard Business School's Advanced Management Program.
The appointment aims to leverage Marasco's global experience to build upon Afrezza's positive clinical trial results and drive strategic growth in the company's endocrine business.
MannKind (MNKD) has announced significant debt restructuring through exchange agreements with certain holders of its 2.50% Convertible Senior Notes due 2026. The company will exchange approximately $193.7 million of Notes for 26,749,559 shares of common stock and make a cash payment of $89.2 million to the holders.
This transaction reduces MannKind's total outstanding debt by 84%, decreasing from $230 million to approximately $36.3 million. The exchange will save approximately 10.4 million shares of potential dilution and reduce annual interest expense by $4.9 million to $0.9 million. Following the exchange, MannKind's cash balance will exceed $180 million with approximately 302.5 million shares outstanding.
MannKind (MNKD) announced six-month results from its Phase 3 INHALE-1 study of Afrezza (inhaled insulin) in children and adolescents aged 4-17 years. The 26-week trial involved 230 subjects randomized to either Afrezza or multiple daily injections (MDI) of rapid-acting insulin.
The modified intent-to-treat (mITT) analysis, excluding one non-adherent patient, demonstrated non-inferiority of Afrezza to MDI with a between-group difference of 0.370% in HbA1c change, meeting the primary endpoint's threshold of 0.4%. No significant differences in lung function or safety parameters were observed between groups. The company plans to meet with FDA regarding a potential supplemental new drug application (sNDA) submission in first half of 2025.
MannKind (MNKD) announced that India's Central Drugs Standard Control Organisation (CDSCO) has approved Afrezza (insulin human) Inhalation Powder for adults. This approval follows existing approvals in the United States and Brazil. The company expects to ship the product to their partner Cipla by the end of 2025.
This milestone is particularly significant as India has the second-highest burden of diabetes worldwide, with over 74 million people affected. The partnership between MannKind and Cipla, established in May 2018, involves Cipla handling regulatory approvals, marketing, and sales in India, while MannKind is responsible for product supply.
According to the International Diabetes Federation, diabetes affects 537 million adults globally, with projections reaching 643 million by 2030 and 783 million by 2045.
MannKind (MNKD) reported strong financial results for Q3 2024, with total revenues reaching $70 million, up 37% from Q3 2023. Year-to-date revenues reached $209 million, a 49% increase from the previous year. The growth was primarily driven by Tyvaso DPI revenues, with royalties increasing 34% to $27.1 million. Afrezza net revenue grew 12% to $15 million. The company achieved a net income of $20 million year-to-date and reported significant progress in clinical trials, including MNKD-101 Phase 3 expansion and successful completion of MNKD-201 Phase 1.
MannKind (Nasdaq: MNKD) has announced its participation in the 2024 UBS Healthcare Conference in Rancho Palos Verdes, California. CEO Michael Castagna and CFO Chris Prentiss will participate in a fireside chat on Tuesday, November 12, at 10:15 a.m. Pacific Time. The company, which specializes in developing inhaled therapeutic products for endocrine and orphan lung diseases, will provide company updates during the session. The presentation will be accessible via live audio webcast on MannKind's website, with a recorded version available for approximately 30 days after the event.
MannKind (MNKD) announced successful completion of Phase 1 trial for nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases. The trial met its primary objective, demonstrating safety and tolerability in healthy volunteers. Key highlights include absence of typical adverse events associated with oral nintedanib, particularly GI and neurologic events. Only mild, transient adverse events were noted - cough and FEV-1 drop, which fully recovered. The study included single and multiple-ascending doses in adults over 40 years. The company plans to meet with FDA in first half of 2025 to discuss late-stage development.
MannKind (Nasdaq: MNKD) has scheduled its third quarter 2024 financial results release for Thursday, November 7, 2024, after market close. The company will host a webcast at 4:30 p.m. Eastern Time to discuss quarterly results and provide a business update. CEO Michael Castagna and CFO Chris Prentiss will lead the conference call. The webcast will be available on MannKind's investor relations website, with a replay accessible for approximately 90 days.
MannKind (Nasdaq: MNKD) announced positive 30-week results from its Phase 4 INHALE-3 study for Afrezza®, an inhaled insulin for type 1 diabetes. The study showed that more adults achieved target A1c levels (<7%) when switching to or remaining on Afrezza plus basal insulin, compared to usual care (multiple daily injections or insulin pumps).
Key findings include:
- 100% increase in subjects achieving A1c <7% at 30 weeks in the Afrezza-treated group from baseline
- More than double the subjects achieved A1c <7% at week 30 after switching from usual care to Afrezza at week 17
The company plans to present detailed results at upcoming conferences, including ATTD in March and additional events in 2025.