MannKind's FUROSCIX ReadyFlow Autoinjector Submitted for FDA Review; PDUFA Date Scheduled for July
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Should l Buy MNKD?
Source: NASDAQ.COM
FDA Review Acceptance: MannKind Corp.'s supplemental new drug application for the FUROSCIX ReadyFlow Autoinjector, aimed at treating edema in adults with chronic heart failure or chronic kidney disease, has been accepted by the FDA, with a decision expected by July 26, 2026.
Advantages of ReadyFlow Autoinjector: The ReadyFlow Autoinjector is designed to deliver a dose of furosemide in under 10 seconds, potentially reducing hospital admissions and overall healthcare costs compared to the current On-Body Infusor, which takes about 5 hours.
Positive Study Results: The sNDA submission is backed by positive trial results showing that the ReadyFlow Autoinjector meets FDA bioavailability requirements and provides comparable therapeutic outcomes to intravenous furosemide, with minimal side effects.
Market Performance: MannKind's stock closed at $5.43, reflecting a 1.50% increase, with trading volume significantly higher than average, indicating strong investor interest over the past year.
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Analyst Views on MNKD
Wall Street analysts forecast MNKD stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 5.630
Low
7.50
Averages
9.25
High
11.00
Current: 5.630
Low
7.50
Averages
9.25
High
11.00
About MNKD
MannKind Corporation is a biopharmaceutical company engaged in transforming chronic disease care through patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, it develops and commercializes treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. Its commercial assets include Afrezza, FUROSCIX and V-Go along with Tyvaso DPI. Its commercializing Afrezza (insulin human) Inhalation Powder, an ultra-rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Its orphan lung disease product, Tyvaso DPI (treprostinil) inhalation powder, is used in the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Study Launch: MannKind Corporation announced the enrollment of the first patient in the INHALE-1ST clinical study, which evaluates the use of Afrezza inhalation powder shortly after a type 1 diabetes diagnosis in children, aiming to alleviate the injection burden for families.
- Study Design: The study will assess the safety and efficacy of Afrezza used in combination with once-daily basal insulin in youth aged 10 to 18 newly diagnosed with type 1 diabetes, with approximately 100 patients expected to be recruited over a 13-week period.
- FDA Review Progress: The FDA has accepted a supplemental Biologics License Application for Afrezza in children and adolescents, with a target action date of May 29, 2026, which, if approved, would mark the first needle-free insulin option in over 100 years.
- Market Potential: MannKind CEO Michael Castagna stated that the INHALE-1ST study provides a crucial opportunity for early treatment, potentially improving mealtime glucose management for youth with diabetes, further driving the company's innovation in diabetes care.
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- FDA Approval Update: MannKind Corporation announced that the FDA has approved an update to the Afrezza prescribing information, adding guidance for transitioning patients from multiple daily injections or insulin pump therapy, aimed at providing clearer, evidence-based dosing directions for healthcare providers.
- Clinical Data Support: The update includes a conversion table and dosing recommendations supported by clinical data from the Dose Optimization and INHALE-3 studies, ensuring that healthcare teams can make more precise decisions when initiating Afrezza for patients.
- Market Uniqueness: Afrezza remains the only inhaled mealtime insulin available in the U.S. market, and MannKind is advancing additional clinical initiatives to expand its use across broader patient populations, further solidifying its market position.
- Future Outlook: The FDA has accepted a supplemental Biologics License Application (sBLA) for Afrezza to expand its use to children and adolescents aged 4-17, with a target action date of May 29, 2026, indicating the company's strategic focus on pediatric diabetes treatment.
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- Clinical Study Launch: MannKind Corporation announced the enrollment of the first patient in the INHALE-1ST clinical study, which evaluates the use of Afrezza inhalation powder shortly after a type 1 diabetes diagnosis in children, aiming to alleviate the injection burden for families.
- Study Design: The study will assess the safety and efficacy of Afrezza used in combination with once-daily basal insulin in youth aged 10 to 18 newly diagnosed with type 1 diabetes, with approximately 100 patients expected to be recruited over a 13-week period.
- FDA Review Progress: The FDA has accepted a supplemental Biologics License Application for Afrezza in children and adolescents, with a target action date of May 29, 2026, which, if approved, would mark the first needle-free insulin option in over 100 years.
- Market Potential: MannKind CEO Michael Castagna stated that the INHALE-1ST study provides a crucial opportunity for early treatment, potentially improving mealtime glucose management for youth with diabetes, further driving the company's innovation in diabetes care.
See More
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- Market Size Surge: The global longevity infrastructure is projected to reach $27 trillion by 2030, driving a shift in the healthcare sector towards regenerative medicine, which is expected to grow to $578.59 billion by 2033, indicating substantial investment potential.
- Cell Therapy Market Growth: The cell therapy market is anticipated to hit $8.85 billion by 2026, while AI-driven drug discovery platforms are set to accelerate to $24.51 billion, suggesting that institutional investors are positioning for the convergence of cell encapsulation technology and precision metabolic delivery.
- Technological Innovation Breakthrough: Avant Technologies' Cell-in-a-Box® technology addresses the critical issue of transplanted cells being destroyed by the immune system by creating a protective barrier around them, thus eliminating the need for immunosuppressive drugs and enhancing the safety and scalability of diabetes therapies.
- Massive Market Opportunity: With 589 million people globally living with type 1 and insulin-dependent type 2 diabetes, projected to rise to 853 million by 2050, Avant's partnership with SG Austria to develop a bioartificial pancreas aims to restore natural glucose control and meet the demands of this vast market.
See More
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- Market Growth Surge: The global longevity infrastructure market is projected to reach $27 trillion by 2030, driving a shift in the healthcare sector towards regenerative medicine, which is expected to grow to $578.59 billion by 2033, indicating substantial investment potential.
- Cell Therapy Market Expansion: The cell therapy market is anticipated to hit $8.85 billion by 2026, while AI-driven drug discovery platforms are accelerating towards $24.51 billion, suggesting that institutional investors are positioning for the convergence of cell-encapsulation technology and precision metabolic delivery.
- Innovative Technology Application: Avant Technologies showcased its Cell-in-a-Box® technology at the EPITA Symposium, aimed at addressing the issue of transplanted cells being destroyed by the immune system, providing a safe and scalable diabetes treatment solution that could significantly enhance the quality of life for type 1 and insulin-dependent type 2 diabetes patients.
- Significant Market Opportunity: With 589 million people globally living with type 1 and insulin-dependent type 2 diabetes, projected to rise to 853 million by 2050, Avant's partnership with SGAustri to develop a bioartificial pancreas is poised to capture a significant share of this vast market.
See More
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- Massive Market Potential: The global next-gen treatment market is projected to reach $88.85 billion by 2030, driven by a surge in funding for high-tech cures, positioning Avant Technologies at the center of this transformation with significant market opportunities.
- Technological Innovation: Avant's cell encapsulation technology addresses the immune rejection issue in regenerative medicine, allowing genetically modified cells to thrive in the body long-term, significantly reducing the side effects of traditional treatments and enhancing patient quality of life.
- Strategic Partnerships: The collaboration with SGAustria to develop diabetes treatments targets a market projected to reach 853 million patients by 2050, positioning Avant's technology to capture a significant share of this vast market.
- Diversified Market Approach: Avant's second joint venture, Klothonova, focuses on anti-aging and age-related diseases, backed by over 50 peer-reviewed studies, showcasing its strategic advantage across multiple high-value healthcare markets.
See More
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- Massive Market Potential: The global next-gen treatment market is projected to reach $88.85 billion by 2030, driven by a surge in funding for high-tech cures, positioning Avant Technologies at the center of this transformation with significant market opportunities.
- Technological Breakthrough: Avant's cell encapsulation technology addresses a fundamental issue in regenerative medicine by protecting therapeutic cells from immune system attacks, significantly reducing the side effects associated with traditional drugs and enhancing treatment efficacy.
- Strategic Partnership: The collaboration with SGAustria aims to develop treatments for diabetes using genetically modified cells that produce insulin, potentially offering new therapeutic options for the 589 million diabetes patients worldwide, highlighting substantial market potential.
- Diverse Market Applications: Avant's technology is not limited to diabetes but can also be applied to Alzheimer's and cardiovascular diseases, with related markets expected to reach $32.8 billion by 2033, showcasing strong market adaptability and growth potential.
See More
MannKind Receives FDA Approval for Afrezza Label Update
- FDA Approval Update: MannKind Corporation announced that the FDA has approved an update to the Afrezza prescribing information, adding guidance for transitioning patients from multiple daily injections or insulin pump therapy, aimed at providing clearer, evidence-based dosing directions for healthcare providers.
- Clinical Data Support: The update includes a conversion table and dosing recommendations supported by clinical data from the Dose Optimization and INHALE-3 studies, ensuring that healthcare teams can make more precise decisions when initiating Afrezza for patients.
- Market Uniqueness: Afrezza remains the only inhaled mealtime insulin available in the U.S. market, and MannKind is advancing additional clinical initiatives to expand its use across broader patient populations, further solidifying its market position.
- Future Outlook: The FDA has accepted a supplemental Biologics License Application (sBLA) for Afrezza to expand its use to children and adolescents aged 4-17, with a target action date of May 29, 2026, indicating the company's strategic focus on pediatric diabetes treatment.
See More
