DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today provided business updates and outlined anticipated growth drivers for 2026, including progress across its commercial programs and clinical development initiatives. “MannKind closed 2025 on a high note, marked by milestones ...

MannKind Corporation (NASDAQ:MNKD) is one of the best NASDAQ stocks to buy in 2026. On December 23, MannKind Corporation secured FDA approval for the FUROSCIX On-body Infusor to treat pediatric patients weighing 43 kg or more. This expands the treatment’s existing reach beyond adults with chronic heart failure/CHF and chronic kidney disease/CKD, providing a home-based option for managing fluid buildup/edema. Earlier on December 1, MannKind Corporation (NASDAQ:MNKD) announced that the US FDA accepted for ...

This biotech innovator in inhaled therapeutics reported a notable insider sale amid ongoing product development and licensing activity.On Dec. 17, 2025, Michael Castagna, Chief Executive Officer of MannKind Corporation (MNKD +0.00%), executed an exercise and immediate sale of 65,804 common shares for a transaction value of approximately $395,482, according to the SEC Form 4 filing.Transaction summaryMetricValueShares sold (direct)65,804Transaction value~$395,482Post-transaction shares (direct ownership)2,50 ...

Core Viewpoint - MannKind Corporation has announced significant updates regarding the FUROSCIX product line, including the approval of the FUROSCIX On-body Infusor for pediatric patients and the issuance of new patents for the FUROSCIX ReadyFlow Autoinjector, which is currently under FDA review [1][4]. Group 1: Product Approvals - The FDA has approved a supplemental New Drug Application (sNDA) for the FUROSCIX On-body Infusor, expanding its indication to pediatric patients weighing 43 kg or more [2]. - FUROSCIX was previously approved for adults with edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) [2][9]. - The approval fulfills all post-marketing requirements under the Pediatric Research Equity Act [2]. Group 2: Intellectual Property Protection - The U.S. Patent and Trademark Office (USPTO) has issued five new patents for the FUROSCIX ReadyFlow Autoinjector, which cover high-concentration liquid compositions of furosemide and associated treatment methods potentially through 2040 [4]. - These patents enhance MannKind's intellectual property position and will be listed in the FDA's Orange Book if the autoinjector is approved [4][5]. Group 3: Potential Impact of New Products - The FUROSCIX ReadyFlow Autoinjector, if approved, could deliver an IV-equivalent diuretic dose in under 10 seconds, allowing patients to manage fluid buildup episodes at home [6][7]. - This innovation is expected to significantly reduce hospital visits, improve quality of life, and lower healthcare costs for patients, providers, and payers [8].

Drugmaker Cipla has launched Afrezza (insulin human) inhalation powder, the company said, about a year after the product got regulatory approval in India. The company has the exclusive distribution and marketing rights of Afrezza, a rapid-acting orally-inhaled insulin, which offers a needle-free alternative to injectable insulin therapy, it said, without disclosing its pricing. Afrezza from US’ MannKind Corporation dissolves rapidly upon oral inhalation and begins lowering blood glucose within approximately ...

Core Insights - MannKind Corporation (MNKD) reported strong Q3 '25 results, with Non-GAAP EPS of $0.07, exceeding estimates by approximately $0.04 [1] - Revenue for the quarter reached $82.13 million, also surpassing expectations [1] Company Overview - MannKind Corporation is focused on biotechnology, particularly in drug development and therapeutic research [1] - The company aims to innovate through unique mechanisms of action and first-in-class therapies, which could reshape treatment paradigms [1] Analyst Background - The analysis is conducted by a professional with a Master's degree in Cell Biology and extensive experience in drug discovery and biotechnology investment [1] - The analyst emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities [1]

Core Insights - MannKind Corporation (MNKD) reported strong Q3 '25 results, with Non-GAAP EPS of $0.07, exceeding estimates by approximately $0.04 [1] - Revenue for the quarter reached $82.13 million, also surpassing expectations [1] Company Overview - MannKind Corporation is focused on biotechnology, particularly in drug development, leveraging scientific expertise to identify innovative therapies [1] - The company aims to deliver research that combines technical soundness with investment-driven insights, emphasizing the importance of evaluating drug candidates and market opportunities [1]

Core Viewpoint - MannKind Corporation has announced that the FDA has accepted the supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow™ Autoinjector, which aims to provide a subcutaneous furosemide injection in under 10 seconds for patients with chronic heart failure (CHF) or chronic kidney disease (CKD) [1][2] Group 1: Product Development and Approval - The FUROSCIX ReadyFlow Autoinjector is designed to deliver treatment in under 10 seconds, potentially transforming the management of fluid buildup in adults with CHF or CKD, thereby reducing hospital admissions and overall healthcare costs [2][8] - The sNDA has a Prescription Drug User Fee Act (PDUFA) target action date set for July 26, 2026 [1][8] - If approved, the ReadyFlow Autoinjector would allow patients to manage fluid buildup episodes at home, contrasting with the existing FUROSCIX On-body Infusor, which requires a five-hour administration time [2][8] Group 2: Clinical Study Results - Positive study results from August 2024 support the sNDA, showing that furosemide via the ReadyFlow Autoinjector achieved a bioavailability of 107.3% within the 90% confidence interval limit of 80 to 125 percent [3] - Participants using the ReadyFlow Autoinjector exhibited similar urine output and urinary excretion metrics compared to intravenous furosemide, indicating comparable efficacy [3] - The study involved 21 healthy volunteers aged 45 to 80 and utilized a randomized, two-way crossover design [4]

Core Viewpoint - Truist Securities has initiated coverage on MannKind (NASDAQ: MNKD) with a Buy rating and a price target of $9 [1] Group 1: Commercial and Development Programs - MannKind's execution in both commercial and development programs is viewed positively by Truist [2] - The valuation outlook is primarily driven by Tyvaso DPI royalty revenue, with projected growth in idiopathic pulmonary fibrosis (IPF) and pulmonary hypertension associated with interstitial lung disease (PPF) [2] - Truist estimates peak revenue of approximately $300 million for the Tyvaso franchise by 2030 [2] Group 2: Additional Growth Opportunities - Additional upside is anticipated from Afrezza in diabetes, with potential expansion into pediatric use next year [3] - Furoscix, acquired through the purchase of scPharma, is also expected to contribute to growth [3] - MannKind's orphan-lung pipeline offers further diversification and long-term growth opportunities [3]

Summary of MannKind Conference Call Company Overview - **Company**: MannKind Corporation (NasdaqGM: MNKD) - **Date**: November 19, 2025 - **Focus**: Development and commercialization of innovative therapies for diabetes and other serious conditions Key Points Industry and Market Opportunities - **Furoscix**: An on-body infuser for furosemide targeting heart failure patients, representing a market opportunity exceeding $10 billion in the U.S. and G7 countries [1][2] - **Fluid Edema Episodes**: Approximately 2.1 million episodes in the U.S., with 80% of costs attributed to hospitalizations due to inability to administer IV Lasix at home [2] - **Readmission Penalties**: New penalties for physicians based on managing heart failure patients effectively, potentially impacting their compensation by 15%-20% [2] Financial Performance - **Furoscix Revenue**: Generated $19.3 million in Q3, with a year-over-year growth of 93% [3] - **Doses Dispensed**: Over 61,000 doses dispensed, with 27,000 in Q3 alone [3] Product Development and Sales Strategy - **Sales Force Expansion**: Increased from a small team to 80 representatives, enhancing market penetration [3][4] - **Nephrology Indication**: 15% of Q3 sales attributed to nephrology, expected to grow further [4] - **Market Engagement**: Targeting 5,000 to 7,000 cardiologists and nephrologists to increase product awareness and adoption [5] Technological Innovations - **FDKP Technology**: Aimed at providing an IV-like experience for bumetanide, enhancing bioavailability and patient compliance [7][8] - **Auto Injector Development**: Designed to simplify administration for patients, reducing the hassle associated with on-body infusers [6] Competitive Landscape - **Tyvaso DPI**: Marketed by United Therapeutics, reported $59 million in Q3 revenue, up 15% year-over-year [9] - **Collaboration with United Therapeutics**: Ongoing partnerships to enhance product offerings and market reach [10][25] Future Trials and Research - **Phase One Trials**: Initiating trials for new formulations, including a nebulized version of clofazimine and a dry powder inhalation for IPF [11][12] - **Pediatric Market Focus**: Exploring opportunities in the pediatric diabetes market, with potential for significant revenue growth [16][17] Revenue Projections - **Pro Forma Revenues**: Expected to exceed $100 million in Q3, driven by product growth and collaborations [24] - **Market Potential**: Every 100,000 patients represents approximately $350 million in revenue, indicating a large unmet need in the market [25] Strategic Vision - **Long-term Growth**: Emphasis on building a diversified pipeline and inline revenue, with a focus on innovative therapies for diabetes and cardiometabolic conditions [26] Additional Insights - **Gestational Diabetes Opportunity**: Physicians have expressed interest in Afrezza for gestational diabetes, highlighting its safety and efficacy [22][23] - **AI Integration**: Future plans to incorporate AI for real-time insulin control and patient management [21] This summary encapsulates the key insights and strategic directions discussed during the MannKind conference call, highlighting the company's focus on innovative therapies and market expansion opportunities.