DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), today announced Chief Executive Officer Michael Castagna, PharmD is scheduled to present and share business updates during the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Thursday, February 26, 2026, at 11:20 a.m. ET A link to the webcast of the presentation will be available on MannKind Corporation’s website at: https://investors.mannkindcorp.com/events-and-presentations. R ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 18, 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 announced that it will release its fourth quarter and full year 2025 financial results before the market opens on Thursday, February 26, 2026. MannKind will host a webcast beginning at 9:00 a.m. Eastern Time to review the f ...

Core Viewpoint - MannKind Corporation has initiated the INHALE-1 clinical study to evaluate the safety and efficacy of Afrezza inhaled insulin in youth aged 10 to under 18 years recently diagnosed with type 1 diabetes, aiming to reduce the burden of insulin injections for pediatric patients and their families [1][2]. Group 1: Study Details - The INHALE-1 study will assess Afrezza used in combination with subcutaneously injected basal insulin once daily, focusing on clinical outcomes and participant satisfaction [2]. - The study will enroll approximately 100 patients across about 10 clinical sites in the United States, with the first patient enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado [3]. - Participants will be followed for 13 weeks during the main phase, with an optional extension phase for up to 26 weeks [4]. Group 2: Primary Endpoint and Objectives - The primary endpoint is the percentage of participants with a Continuous Glucose Meter (CGM) measuring time in range (TIR) of 70-180 mg/dL at least 70% during the 14 days prior to the 13-week visit [4]. - The study aims to evaluate whether replacing most insulin injections with inhalations can ease the adjustment to managing type 1 diabetes for children and their families [2]. Group 3: Regulatory Status - The FDA is currently reviewing a supplemental Biologics License Application (sBLA) for Afrezza in children and adolescents with type 1 or type 2 diabetes, with a target action date of May 29, 2026 [5]. - If approved, Afrezza would be the first needle-free insulin option for pediatric patients in over a century [5]. Group 4: Company Overview - MannKind Corporation is focused on transforming chronic disease care through innovative solutions, particularly in cardiometabolic and orphan lung diseases [9][10]. - The company aims to develop treatments that address serious unmet medical needs, including diabetes and related conditions [9].

Core Viewpoint - MannKind Corporation is misclassified as a volatile biotech, while it is actually an increasingly diversified, revenue-driven pharmaceutical company [1] Group 1: Company Overview - MannKind Corporation is positioned as a diversified pharmaceutical company rather than a volatile biotech [1] - The company has a focus on innovative biotechnology, emphasizing unique mechanisms of action and first-in-class therapies [1] Group 2: Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The analyst has been active in the investing space for five years, with a focus on biotech equity analysis [1] Group 3: Research Approach - The research approach combines scientific expertise with financial and market analysis to evaluate drug candidates and their market opportunities [1] - The analysis emphasizes the importance of understanding the science behind drug candidates, competitive landscape, clinical trial design, and financial fundamentals [1]

Core Insights - MannKind Corporation is being misclassified as a volatile biotech company, while it is actually an increasingly diversified, revenue-driven pharmaceutical company [1] Company Analysis - The company has a strong foundation in scientific research, with a focus on drug development and innovative biotechnology [1] - MannKind aims to identify and develop unique therapies that can reshape treatment paradigms, emphasizing novel mechanisms of action and first-in-class therapies [1] Market Perspective - The biotech sector presents opportunities for significant returns due to breakthrough science, but it also requires careful scrutiny of the underlying science and market dynamics [1] - The analysis will cover companies at various stages of development, from early clinical pipelines to commercial-stage biotechs, highlighting the importance of evaluating clinical trial design and competitive landscape [1]

Core Viewpoint - MannKind Corporation announced the FDA's approval of an updated prescribing information for Afrezza, which includes revised recommendations for starting mealtime dosages when transitioning patients from subcutaneous insulin to inhaled insulin [1][2]. Group 1: FDA Approval and Label Update - The updated label aims to provide clearer guidance for healthcare providers on starting doses when switching patients to Afrezza from subcutaneous insulin [2]. - The label update is supported by modeling data and results from the Dose Optimization study and the INHALE-3 trial, which showed improved postprandial glucose outcomes with the new dosing recommendations [2][4]. Group 2: Recommended Dosing Information - The revised dosing recommendations include specific conversions from injected mealtime insulin to Afrezza, such as: - Up to 3 units of subcutaneous insulin corresponds to 4 units of Afrezza - 4 to 5 units corresponds to 8 units - 6 to 7 units corresponds to 12 units [5][4]. Group 3: Product Overview - Afrezza is the only ultra-rapid acting inhaled insulin approved by the FDA for improving glycemic control in adults with diabetes mellitus, utilizing MannKind's Technosphere technology for rapid absorption [6]. - The product is administered at the beginning of meals using a portable inhaler, mimicking the body's natural insulin response [6]. Group 4: Safety Information - Afrezza is contraindicated in patients with chronic lung diseases such as asthma or COPD due to the risk of acute bronchospasm [7][12]. - The most common adverse reactions associated with Afrezza include hypoglycemia, cough, and throat irritation [18].

Core Insights - MannKind Corporation (NASDAQ:MNKD) is identified as a stock with high potential under $10, with significant growth drivers anticipated for 2026 [1] Financial Performance - The company closed fiscal 2025 with record fourth quarter revenue exceeding $100 million, indicating strong financial performance [2] Regulatory Milestones - The FDA is expected to provide updates on the Afrezza label on January 23, which aims to simplify dosing for patients transitioning from injectable rapid-acting insulin, potentially increasing adoption among adults with diabetes [2] - A supplemental Biologics License Application (sBLA) for Afrezza has a PDUFA target date of May 29, 2026, which, if approved, would introduce the first needle-free insulin for pediatric patients [3] - The FDA is also anticipating a supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow Autoinjector, with a PDUFA date of July 26, 2026, which would enable the delivery of an 80 mg/ml IV-equivalent diuretic dose in under 10 seconds if approved [3] Analyst Ratings - Wall Street analysts are optimistic about the stock, with Gregory Renza from Truist Financial reiterating a Buy rating on January 13, and Brandon Folkes from H.C. Wainwright also maintaining a Buy rating with a price target of $11 on January 9 [4] Company Overview - MannKind Corporation is a biopharmaceutical company focused on developing and commercializing innovative therapeutic devices and products for serious unmet medical needs in endocrine and orphan lung diseases. Its product pipeline includes Afrezza, Pediatric Afrezza, V-Go, Tyvaso DPI, MNKD-101, MNKD-201, MNKD-301, and MNKD-501 [5]

Core Viewpoint - MannKind (MNKD) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on an upward trend in earnings estimates, which significantly influences stock prices [1][2]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [3][5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [3]. Business Improvement Indicators - The upgrade in MannKind's rating suggests an improvement in the company's underlying business, which is expected to be reflected in higher stock prices as investors respond positively to this trend [4][9]. Earnings Estimate Revisions for MannKind - MannKind is projected to earn $0.08 per share for the fiscal year ending December 2025, with no year-over-year change; however, the Zacks Consensus Estimate has increased by 21.4% over the past three months, indicating a positive revision trend [7]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988, highlighting the effectiveness of this rating system [6][8]. - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating that MannKind's upgrade places it among the best candidates for potential market-beating returns [9].

Core Insights - MannKind Corporation is focused on transforming chronic disease care through innovative solutions for cardiometabolic and orphan lung diseases, with significant growth anticipated in 2026 [1][3] Business Updates - MannKind closed 2025 with a record-setting fourth quarter, surpassing $100 million in net revenue, and completed the acquisition of scPharmaceuticals [2] - The company is preparing for two high-potential product launches in 2026, which are expected to drive long-term value creation [2] Major Catalysts for 2026 - Afrezza (insulin human) Inhalation Powder is a key product with an FDA decision on a label update anticipated by January 23, 2026, which would update the initial dose for mealtime insulin [5] - The FDA has accepted for review the supplemental Biologics License Application for Afrezza in children and adolescents, with a target action date of May 29, 2026, potentially making it the first needle-free insulin option for pediatric patients in over a century [5] - FUROSCIX ReadyFlow Autoinjector has also been accepted for review by the FDA, with a target action date of July 26, 2026, which would deliver an IV-equivalent diuretic dose in under 10 seconds if approved [5] - Nintedanib DPI (MNKD-201) has enrolled its first patient in a Phase 1b study, with further developments expected in 2026 [5] - The company is advancing pre-clinical development for Bumetanide DPI (MNKD-701) and formulating a second dry powder investigational molecule under collaboration with United Therapeutics [5]

Core Insights - MannKind Corporation has received FDA approval for the FUROSCIX On-body Infusor for pediatric patients, expanding its treatment options for chronic heart failure and chronic kidney disease [1][3] - The company also announced that the FDA accepted a Supplemental NDA for the FUROSCIX ReadyFlow Autoinjector, with a target action date set for July 26, 2026 [2] - The ReadyFlow Autoinjector is designed to deliver a subcutaneous dose of furosemide in under 10 seconds, significantly faster than the On-body Infusor, which takes 5 hours [3] Company Overview - MannKind Corporation is a biopharmaceutical company focused on developing and commercializing therapeutic products for endocrine and orphan lung diseases in the US [4]