MannKind to Participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference
MannKind Corporation announced that CEO Michael Castagna will present a business update at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Thursday, February 26, 2026, at 11:20 a.m. ET. A webcast of the presentation will be available on the company's investor relations website, with recorded versions accessible for about 90 days afterward. MannKind is a biopharmaceutical company focused on chronic disease care for conditions like diabetes and pulmonary hypertension.
MannKind to Participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference
MannKind Corporation announced that CEO Michael Castagna is scheduled to present and provide business updates at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, at 11:20 a.m. ET. A webcast of the presentation will be available on the company's investor relations website, with recorded versions also accessible for approximately 90 days. MannKind is a biopharmaceutical company focused on transforming chronic disease care, particularly in cardiometabolic and orphan lung diseases.
MannKind (MNKD) to Release Earnings on Wednesday
MannKind (NASDAQ: MNKD) is scheduled to release its Q4 2025 earnings before the market opens on Wednesday, February 25th, with analysts forecasting a loss of ($0.01) per share. The biopharmaceutical company, which specializes in inhaled therapeutic products like Afrezza for diabetes, currently has a "Moderate Buy" consensus rating and a target price of $10.06 from Wall Street analysts. Recent insider selling, including by CEO Michael Castagna, totals $1.55 million over the last 90 days, while institutional investors have increased their holdings.
MannKind to Report Fourth Quarter and Full Year 2025 Financial Results on February 26, 2026
MannKind Corporation announced it will release its fourth-quarter and full-year 2025 financial results before market open on Thursday, February 26, 2026. The biopharmaceutical company will also host a webcast at 9:00 a.m. Eastern Time to discuss the results and provide a business update, with a replay available on their investor relations website. MannKind specializes in innovative, patient-centric solutions for cardiometabolic and orphan lung diseases.
MannKind’s Pediatric Afrezza Trial Puts Needle Free Insulin Thesis To Test
MannKind has initiated enrollment for its pivotal INHALE-1ST trial of Afrezza inhaled insulin in pediatric patients, specifically for newly diagnosed type 1 diabetes in children and adolescents. This trial, along with a pending FDA review for pediatric label expansion, could make Afrezza the first needle-free insulin option for young patients in the U.S. Investors are closely watching clinical outcomes and the FDA's decision, which are expected to significantly influence Afrezza's market potential and adoption in youth diabetes care.
MannKind (MNKD) Begins Enrollment for Pediatric Diabetes Study
MannKind Corporation (MNKD) has commenced enrollment for INHALE-1ST, a pivotal clinical trial evaluating its Afrezza Inhalation Powder for early intervention in pediatric type 1 diabetes. Despite strong revenue growth and profitability metrics, as well as solid liquidity, the company faces concerns regarding insider selling and a low Altman Z-Score indicative of financial distress risks. Investors are advised to consider the mixed valuation metrics and sector-specific risks, alongside potential catalysts from clinical trial results.
MannKind enrolls first patient in pediatric inhaled insulin study
MannKind Corporation has enrolled the first patient in its INHALE-1ST clinical study, evaluating Afrezza inhaled insulin for newly diagnosed type 1 diabetes patients aged 10 to under 18 years. The study will assess the safety and efficacy of Afrezza alongside once-daily injected basal insulin, with a target enrollment of about 100 patients. The FDA is also reviewing a supplemental Biologics License Application for Afrezza in pediatric patients, with a decision expected by May 29, 2026.
Inhaled insulin trial aims to cut shots for kids with new type 1 diabetes
MannKind Corporation has announced the enrollment of the first patient in its INHALE-1ST pediatric study for Afrezza, an inhaled insulin. The study aims to evaluate the safety and efficacy of Afrezza combined with once-daily basal insulin in youth aged 10 to less than 18 years recently diagnosed with type 1 diabetes. This clinical trial, involving approximately 100 patients across 10 U.S. sites, seeks to potentially reduce the burden of multiple daily injections for these young patients and has a PDUFA date of May 29, 2026, for a pediatric sBLA.
MannKind Corporation Enrolls First Patient in INHALE-1ST Clinical Study for Pediatric Type 1 Diabetes Using Afrezza Inhalation Powder
MannKind Corporation announced the enrollment of the first patient in its INHALE-1ST clinical study, which evaluates the use of Afrezza Inhalation Powder for pediatric patients newly diagnosed with type 1 diabetes. The study, led by the Jaeb Center for Health Research, will assess the safety and efficacy of Afrezza alongside subcutaneous basal insulin in youth aged 10 to less than 18 years, aiming to improve mealtime glucose management and satisfaction. This milestone comes as the FDA reviews a supplemental Biologics License Application for Afrezza’s pediatric use, with a target action date of May 29, 2026, potentially offering the first needle-free insulin option for children in over a century.
MannKind Announces First Patient Enrolled in INHALE-1ST Pediatric Study Evaluating Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes (T1D)
MannKind Corporation has announced the enrollment of the first patient in its INHALE-1ST pediatric study, which will evaluate the safety and efficacy of Afrezza (insulin human) Inhalation Powder for youth aged 10 to less than 18 years newly diagnosed with Type 1 Diabetes. The study aims to determine if inhaled insulin can reduce the burden of daily injections and improve mealtime glucose management. This follows the FDA's acceptance of a sBLA for Afrezza in pediatric patients, with a target action date of May 29, 2026.
MannKind Corp Is Suddenly Everywhere – But Is MNKD Actually Worth Your Money?
MannKind Corp (MNKD) is gaining traction on social media, sparking investor interest in its inhaled insulin product, Afrezza, and its lung-delivered drug platform. The article explores whether this biotech underdog is a legitimate investment opportunity or just another hype cycle, emphasizing its volatility and the speculative nature of investing in biotech. It advises potential investors to consider the inherent risks and position sizing carefully.
A Look At MannKind (MNKD) Valuation As Afrezza Secures FDA Label Update On Dosing And Conversion
MannKind Corporation (MNKD) received an FDA label update for its inhaled insulin product, Afrezza, clarifying dosing and conversion for diabetes patients. While the stock's short-term momentum is positive, its long-term performance has seen a decline. The article explores different valuation perspectives, with one narrative suggesting the stock is undervalued at $9.61 per share, while another view points to a high P/E ratio compared to the industry average, indicating potential valuation risk.
MannKind stock gets Buy rating reaffirmation from Truist at $9 target
Truist Securities reaffirmed a Buy rating and a $9.00 price target for MannKind (NASDAQ:MNKD) due to an FDA-approved update to the Afrezza label, which revises starting mealtime doses for patients switching from subcutaneous insulin. This label update is seen as an "incremental positive" supporting continued market uptake and diversification. Despite a high P/E ratio, MannKind shows strong revenue growth, positive financial health, and several approaching catalysts including pediatric expansion decisions and upcoming earnings reports.
HC Wainwright & Co. Reiterates 'Buy' Rating for MNKD with $11 Target
HC Wainwright & Co. has reiterated its 'Buy' rating for MannKind (MNKD) with an unchanged price target of $11.00 USD, reflecting continued confidence in the company's future. This decision follows a period of varied analyst outlooks for MannKind, a biopharmaceutical company focused on inhaled therapeutic products like Afrezza for diabetes. The average one-year price target from nine analysts is $9.61, implying a 73.96% upside from the current price, with a consensus "Outperform" recommendation.
MNKD Stock Gets A Pre-Market Boost From FDA Label Revision For Afrezza
MannKind Corp (MNKD) shares surged over 7% in pre-market trading after the FDA approved an updated label for its Afrezza inhaled insulin. The revised label provides clearer starting-dose guidance for adult patients switching from other insulin therapies. This update is supported by clinical trial results showing improved glucose control, and the company also has a supplemental FDA application pending for Afrezza's use in pediatric patients.
MannKind stock rises after FDA approves updated Afrezza label
MannKind Corporation's stock rose 3.5% after the FDA approved an updated label for its Afrezza insulin inhalation powder. The update provides clearer starting dose guidelines for healthcare providers transitioning patients from subcutaneous mealtime insulin to Afrezza. This change is expected to support healthcare providers in converting patients to the inhaled insulin product.
FDA Approves Label Update for MannKind's (MNKD) Afrezza Insulin
MannKind Corporation (MNKD) has received FDA approval for an updated label for its inhaled insulin product, Afrezza. This update includes new recommendations and a dosage conversion table for patients transitioning from subcutaneous insulin to Afrezza, based on data from the Dose Optimization study and the INHALE-3 trial. While the company shows strong revenue growth and profitability, potential investors should consider warning signs such as a negative Altman Z-Score and significant insider selling.
New Afrezza dosing guide for adults shifting from insulin shots or pumps
MannKind Corporation (Nasdaq: MNKD) announced that the FDA has approved an updated Afrezza prescribing information. This update provides clear guidance and a conversion table for adult patients switching to inhaled Afrezza from subcutaneous mealtime insulin injections or insulin pump boluses. The change aims to support healthcare providers in appropriate initiation of therapy and was based on modeling and in vivo data showing improved postprandial glucose outcomes.
FDA approves updated dosing guidelines for MannKind’s inhaled insulin
The FDA has approved updated prescribing information for MannKind Corporation's (NASDAQ:MNKD) inhaled insulin product, Afrezza. The revised guidelines include new recommendations and a conversion table for transitioning patients from subcutaneous mealtime insulin to Afrezza, aiming to provide clearer dosing guidance for healthcare providers. This update is based on modeling data and clinical trials showing improved glucose outcomes with the new conversion doses.
MannKind Announces FDA Approval of Updated Afrezza Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy
MannKind Corporation announced that the FDA has approved an updated label for Afrezza (insulin human) Inhalation Powder, providing clearer starting dose guidance for patients switching from subcutaneous mealtime insulin regimens. This update is based on clinical trial data, including the Dose Optimization study and INHALE-3 trial, which showed improved postprandial glucose outcomes. The revised recommendations aim to support healthcare providers in making appropriate and safe transitions for adult patients initiating Afrezza therapy.
MannKind’s Volatile Week: Can MNKD Justify The Recent Rebound In Its Stock?
MannKind's stock has experienced significant volatility, with a recent rebound following an initial decline, prompting investors to question if it's a bargain or a value trap. Despite a respectable one-year gain, the stock's path has been turbulent, reflecting a biotech battleground sensitive to each headline. Wall Street analysts maintain a nuanced, cautiously constructive outlook, suggesting MannKind is a selectively interesting idea for risk-tolerant investors awaiting pipeline validation.
MannKind (MNKD) Maps 2026 FDA Catalysts for Afrezza and FUROSCIX ReadyFlow Autoinjector Narrative
MannKind Corporation has outlined key FDA catalysts for 2026, including label updates for Afrezza’s adult dosing, a potential pediatric approval for Afrezza by May 29, 2026, and a decision on the FUROSCIX ReadyFlow Autoinjector by July 26, 2026. These regulatory milestones are crucial for expanding MannKind’s market reach and transitioning it into a broader cardiometabolic platform. Investors are weighing these opportunities against the company's high valuation, debt levels, and the potential impact of any regulatory setbacks.
Assessing MannKind (MNKD) Valuation After Recent Revenue And Profit Results
MannKind (MNKD) has reported annual revenue of US$313.787 million and net income of US$29.233 million, bringing its valuation into focus. While the company's share price shows tentative momentum, its value metrics are low. Simply Wall St's narrative fair value assessment suggests MannKind is undervalued at US$9.61 compared to its current price of US$5.49, assuming significant future growth in revenue and profit margins, although its high P/E ratio compared to the industry average indicates the market is already pricing in a lot of future earnings progress.
MannKind Corporation (MNKD) Reveals 2026 Growth Drivers
MannKind Corporation (NASDAQ: MNKD) announced its 2026 growth drivers, following a strong fiscal 2025 with record fourth-quarter revenue. The company anticipates significant regulatory milestones, including an FDA decision on Afrezza label updates in January, a potential approval for needle-free insulin for pediatrics in May, and a PDUFA date for the FUROSCIX ReadyFlow Autoinjector in July. Wall Street analysts from Truist Financial and H.C. Wainwright have reiterated "Buy" ratings on the stock.
MannKind Corporation (MNKD) Reveals 2026 Growth Drivers
MannKind Corporation (MNKD) closed fiscal 2025 with record fourth-quarter revenue exceeding $100 million and expects significant regulatory milestones in 2026. These include FDA label updates for Afrezza aimed at simplifying pediatric dosing for diabetes patients, and a PDUFA date for the FUROSCIX ReadyFlow Autoinjector. Wall Street analysts from Truist Financial and H.C. Wainwright have reiterated Buy ratings on the stock.
MannKind (NASDAQ:MNKD) Shares Down 6.4% - Here's What Happened
MannKind (NASDAQ:MNKD) shares fell 6.4% during Friday's trading, closing at $5.225 amid higher-than-average volume. The decline occurred despite the company maintaining a "Buy" consensus rating and a target price of $10.06 from analysts, though some recently trimmed their price targets. Insider selling, totaling approximately $1.64 million over the last 90 days, including sales by CEO Michael Castagna, also preceded the stock drop.
Assessing MannKind (MNKD) Valuation As Regulatory Catalysts And Pipeline Updates Draw Investor Attention
MannKind (MNKD) is drawing investor attention due to upcoming FDA decisions for Afrezza and FUROSCIX ReadyFlow, alongside pipeline updates. The company's stock price, currently at US$6.01, is considered undervalued by some analysts who project a fair value of US$9.61, while a model-based fair value suggests US$23.02, despite a high P/E ratio. Investors are evaluating whether the market has fully priced in MannKind's future growth linked to its diabetes and lung disease franchises.
Evaluating MannKind (MNKD) Valuation After Recent Share Price Swings And Long Term Return Profile
This article evaluates MannKind (MNKD)'s valuation after recent share price fluctuations, highlighting that it is currently considered undervalued with a narrative fair value of $9.61 against a closing price of $5.61. The analysis points to the potential for growth driven by Afrezza's performance and pipeline developments, while also cautioning investors about the company's high P/E ratio compared to industry averages and the associated risks. It encourages investors to conduct their own research and provides tools for personalized analysis.
Deltec Asset Management LLC Takes $3.89 Million Position in MannKind Corporation $MNKD
Deltec Asset Management LLC has acquired a new position of 723,500 shares, valued at $3.89 million, in MannKind Corporation (NASDAQ:MNKD) during the third quarter. Institutional investors now own nearly half of the biopharmaceutical company, while analysts rate MNKD as a "Moderate Buy" with a consensus price target of $10.06 despite some recent reductions by Wells Fargo and RBC. The company recently beat quarterly EPS estimates and saw an insider sell-off totaling $1.64 million over the last 90 days.
How 2026 FDA Decisions on Afrezza and FUROSCIX At MannKind (MNKD) Have Changed Its Investment Story
MannKind Corporation's investment story is evolving due to anticipated 2026 FDA decisions on its products, Afrezza and FUROSCIX. These regulatory milestones, including an Afrezza label update and a supplemental NDA for the FUROSCIX ReadyFlow Autoinjector, are expected to significantly influence how investors assess the company's product mix and long-term revenue profile. The article highlights that reliance on a limited core portfolio amidst these upcoming decisions presents a key risk for investors.
MannKind Corporation (NASDAQ:MNKD) Receives Average Rating of "Moderate Buy" from Brokerages
MannKind Corporation (NASDAQ:MNKD) has received an average "Moderate Buy" rating from ten brokerages, with an average 12-month price target of $10.06. Key analyst actions include Royal Bank of Canada decreasing its price target to $7.50, Wall Street Zen upgrading to "buy," and Wells Fargo & Company lowering its target to $8.00. The company recently beat quarterly earnings expectations and has seen significant insider selling totaling $1.64 million over the past 90 days.
Mannkind’s chief people officer sells $297k in stock
Stuart A. Tross, MannKind Corp's Chief People & Workplace Officer, sold 47,006 shares of company stock for $297,547 on January 8, 2026. This transaction was part of a pre-established trading plan, leaving him with 985,007 shares. The sale follows MannKind's positive financial news, including record revenue and potential FDA approvals for its products.
MannKind Corp stock hits 52-week high at 6.33 USD By Investing.com
MannKind Corp (MNKD) achieved a 52-week high of $6.33 USD, with its stock currently at $6.34, reflecting a significant 61.6% surge over the last six months, though its 1-year return shows a-5.19% decline. The biopharmaceutical company has a market capitalization of $1.9 billion and a P/E ratio of 60.73, indicating profitability. Analysts maintain a "Strong Buy" consensus with price targets ranging from $7.50 to $12.00, supported by recent positive news including record quarterly revenue, FDA approvals for FUROSCIX, and increased price targets from Leerink Partners and Truist Securities.
MannKind Rallies On Optimism Of Two Imminent Product Launches: Analyst Sees ‘Multiple Headwinds’ For Stock In 2026
MannKind Corporation is seeing renewed investor optimism and a 2% rally in its shares due to the anticipation of two high-potential product launches in 2026. CEO Michael Castagna believes these launches, including an inhalable insulin for pediatric diabetes and a FUROSCIX autoinjector, will be significant catalysts for long-term value creation. H.C. Wainwright reiterated a 'Buy' rating with an $11 price target, noting that the market may be underestimating the potential tailwinds for the company.
MannKind Corp stock hits 52-week high at 6.33 USD By Investing.com
MannKind Corp stock has reached a 52-week high of $6.33 USD, now trading at $6.34, with a market capitalization of $1.9 billion. Despite a 61.6% surge in the past six months, the stock shows a 1-year decline of 5.19%. Analysts maintain a Strong Buy consensus with price targets indicating potential upside, driven by recent positive news including record Q4 revenue, FDA approvals for FUROSCIX, and raised price targets from Leerink Partners and Truist Securities.
MannKind Corp stock hits 52-week high at 6.33 USD
MannKind Corp's stock has reached a 52-week high of $6.33, with its current price at $6.34, reflecting a significant 61.6% surge over the last six months. Despite a yearly decline of 5.19%, analysts maintain a "Strong Buy" consensus with price targets between $7.50 and $12.00, indicating potential future growth. Recent positive developments include record Q4 revenue, FDA approvals for its FUROSCIX infusor, and a raised price target from Leerink Partners.
MannKind Provides Business Updates and 2026 Growth Drivers
MannKind Corporation has provided business updates and outlined key growth drivers for 2026, building on a strong close to 2025 with record net revenue. The company anticipates significant catalysts this year, including FDA decisions on Afrezza label updates and its approval for pediatric use, as well as the review of the FUROSCIX ReadyFlow Autoinjector. MannKind is also advancing its pipeline and collaborating with United Therapeutics on new dry powder investigational molecules, positioning itself for long-term value creation.
MannKind Provides Business Updates and 2026 Growth Drivers
MannKind Corporation provided business updates and outlined key growth catalysts for 2026, building on a strong close to 2025 with record revenue. The company anticipates significant regulatory decisions for Afrezza, including a label update and potential approval for pediatric use, as well as an FDA decision for the FUROSCIX ReadyFlow Autoinjector. Additionally, MannKind is advancing its pipeline with new clinical studies and collaborations with United Therapeutics, positioning 2026 as a pivotal year for value creation.
Voya Investment Management LLC Sells 480,182 Shares of MannKind Corporation $MNKD
Voya Investment Management LLC significantly reduced its stake in MannKind Corporation (NASDAQ:MNKD) by 89.7% in Q3, selling 480,182 shares and retaining 54,871 shares. Despite this, MannKind has seen various other institutional investors adjust their positions, and 49.55% of the stock is currently owned by institutional investors and hedge funds. The biopharmaceutical company recently exceeded quarterly earnings estimates and holds a "Moderate Buy" consensus rating from analysts with an average price target of $10.06.
MannKind Corp Is Suddenly Everywhere – Is MNKD the Next Sleeper Stock You’ll Regret Ignoring?
MannKind Corp (MNKD), a biotech company focusing on inhaled insulin, is gaining traction among traders and investors, sparking debate on whether it's a legitimate opportunity or just hype. While it offers high-risk, high-reward potential due to its unique drug delivery technology and underdog status against big pharma, investors are advised to conduct thorough research and have a clear trading plan given its volatility. The article advises caution for casual investors, suggesting it's more suited for risk-tolerant traders willing to closely monitor news and market movements.
MannKind Corporation (MNKD) Secures FDA Approval for FUROSCIX Pediatric Use, Expanding Reach In Heart, Kidney Disease Care
MannKind Corporation (MNKD) recently secured FDA approval for pediatric use of its FUROSCIX On-body Infusor for patients weighing 43 kg or more, expanding its reach beyond adults with chronic heart failure and kidney disease. Additionally, the FDA is reviewing a Supplemental NDA for the FUROSCIX ReadyFlow Autoinjector, which promises a faster, home-based treatment option, with a PDUFA target action date of July 26, 2026. These developments aim to improve managing fluid buildup and potentially reduce hospital admissions for these patient populations.
MannKind Corporation (MNKD) Secures FDA Approval for FUROSCIX Pediatric Use, Expanding Reach In Heart, Kidney Disease Care
MannKind Corporation (NASDAQ: MNKD) recently secured FDA approval for its FUROSCIX On-body Infusor for pediatric use in patients weighing 43 kg or more, expanding its application for managing fluid buildup in heart and kidney disease. This approval broadens an existing treatment previously available for adults. Additionally, the company is awaiting FDA review for a new FUROSCIX ReadyFlow Autoinjector, which promises a much faster medication delivery time compared to the current infusor.
Even though MannKind (NASDAQ:MNKD) has lost US$61m market cap in last 7 days, shareholders are still up 80% over 5 years
MannKind (NASDAQ:MNKD) shareholders have seen an 80% return over five years, outperforming the market despite a recent US$61 million market cap drop. The company's shift from loss to profitability has driven this long-term growth. However, in the last year, the stock declined 11%, suggesting potential challenges or a buying opportunity.
Even though MannKind (NASDAQ:MNKD) has lost US$61m market cap in last 7 days, shareholders are still up 80% over 5 years
MannKind (NASDAQ:MNKD) shareholders have seen an 80% return over the past five years, outperforming the broader market despite a recent US$61 million market cap loss. The company has moved from a loss to profitability during this period, which is generally viewed positively by investors. While the stock saw an 11% decline in the last year, its long-term growth and improved fundamentals suggest a potential buying opportunity for investors.
180 Wealth Advisors LLC Increases Stock Position in MannKind Corporation $MNKD
180 Wealth Advisors LLC significantly increased its stake in MannKind Corporation (NASDAQ:MNKD) by 11.2% in the third quarter, making it their sixth-largest holding. This comes as MannKind reported stronger-than-expected quarterly earnings and revenue, with multiple analysts maintaining or upgrading their ratings and price targets. Despite insider stock sales, institutional investors own nearly half of the company's stock, reflecting continued confidence.
How Pediatric FUROSCIX Expansion And New Patents At MannKind (MNKD) Has Changed Its Investment Story
MannKind Corporation recently received FDA approval to expand the use of FUROSCIX on-body Infusor for pediatric patients and secured five new patents for the FUROSCIX ReadyFlow Autoinjector, extending protection through 2040. These developments significantly boost MannKind's clinical and competitive standing for its FUROSCIX platform. The company's investment narrative now focuses on how FUROSCIX, alongside the upcoming FDA review of the ReadyFlow Autoinjector, can drive future growth and reduce reliance on a narrow product portfolio, with forecasts suggesting a substantial upside to its current price.
MannKind stock slips despite FDA clearing pediatric use of heart failure drug — what’s spooking investors?
MannKind's stock experienced a decline despite the FDA clearing its heart failure drug, Tyvaso DPI, for pediatric use, expanding its potential market. While the FDA approval signifies growth potential, investors might be concerned by the perceived weakness in the recent sales of the drug, even though overall growth is still positive. The market reaction suggests that some investors may have anticipated even stronger sales or are focusing on short-term performance rather than long-term growth.
MannKind (MNKD) wins FDA pediatric nod, 5 FUROSCIX patents
MannKind Corporation announced FDA approval for its FUROSCIX On-body Infusor for pediatric patients weighing 43 kg or more, fulfilling Pediatric Research Equity Act requirements. Additionally, the company secured five new U.S. patents for the investigational FUROSCIX ReadyFlow Autoinjector, which is currently under FDA review with a PDUFA date of July 26, 2026, and aims to deliver an IV-equivalent diuretic dose in under 10 seconds. These developments reinforce MannKind's intellectual property and expand treatment options for fluid buildup in specific patient populations.
MannKind Corporation Announces FDA Approval of FUROSCIX® for Pediatric Use and Patent Issuance for FUROSCIX ReadyFlow™ Autoinjector
MannKind Corporation announced FDA approval for FUROSCIX® On-body Infusor for pediatric patients weighing 43 kg or more, expanding its use from adults to treat edema associated with chronic heart failure and chronic kidney disease. Concurrently, the U.S. Patent and Trademark Office issued five new patents for the FUROSCIX ReadyFlow™ Autoinjector, which is under FDA review with a target action date of July 26, 2026. This autoinjector aims to provide rapid, IV-equivalent diuretic doses at home, enhancing patient convenience and potentially reducing hospital visits.
MannKind Stock Slips Despite FDA Clearing Pediatric Use Of Heart Failure Drug — What’s Spooking Investors?
MannKind Corp (MNKD) shares fell despite the FDA approving expanded pediatric use for its Furoscix drug and the company receiving five new patents for its ReadyFlow autoinjector. Investors expressed concerns over the limited commercial impact of the pediatric approval and questioned the timing of the announcement during thin holiday trading. The company's stock has declined 0.9% so far in 2025.
