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About MannKind Corporation (NASDAQ: MNKD)
MannKind Corporation is a leading biopharmaceutical company specializing in the development and commercialization of innovative inhaled therapeutic products. With a mission to address serious unmet medical needs, MannKind focuses on two primary therapeutic areas: endocrine diseases, such as diabetes, and orphan lung diseases, including pulmonary arterial hypertension, pulmonary fibrosis, and nontuberculous mycobacterial (NTM) lung disease.
Core Business Areas
MannKind’s business model revolves around leveraging its proprietary Technosphere® dry-powder technology to deliver drugs via inhalation. This unique platform allows for rapid and effective drug delivery to the deep lungs, providing both systemic and localized therapeutic effects. The company generates revenue through a combination of commercial product sales, royalty agreements, and strategic collaborations.
Product Portfolio
- Afrezza®: A rapid-acting inhaled insulin for adults with diabetes, offering a convenient alternative to injectable insulin. It is approved in the U.S., Brazil, and recently India, where it is marketed through a partnership with Cipla Ltd.
- Tyvaso DPI®: MannKind manufactures this inhaled therapy for pulmonary arterial hypertension under a collaboration with United Therapeutics, contributing significantly to its royalty revenue.
- MNKD-101 (Clofazimine Inhalation Suspension): Currently in Phase 3 trials, this investigational therapy targets refractory NTM lung disease.
- MNKD-201 (Nintedanib DPI): An inhaled therapy for idiopathic pulmonary fibrosis, designed to reduce systemic side effects associated with oral formulations.
Proprietary Technologies
MannKind’s groundbreaking Technosphere® platform enables the creation of dry-powder formulations for inhalation, providing deep lung penetration and rapid onset of action. This technology is complemented by its proprietary inhalation devices, such as the Cricket® inhaler, which enhance patient convenience and adherence.
Market Segments and Competitive Positioning
MannKind operates in highly specialized markets, addressing both chronic and rare diseases. Its focus on inhaled therapies differentiates it from competitors offering traditional oral or injectable treatments. The company’s products cater to diverse patient populations, from adults with diabetes to individuals suffering from rare pulmonary conditions. Strategic partnerships, such as its collaboration with Cipla in India and licensing agreements with Pulmatrix, further strengthen its market presence.
Strategic Initiatives and Clinical Achievements
MannKind is actively advancing its clinical pipeline, with notable milestones including:
- Positive results from the Phase 4 INHALE-3 study, demonstrating the efficacy of Afrezza in improving glycemic control in type 1 diabetes.
- Phase 3 trials for MNKD-101 targeting NTM lung disease, with regulatory clearances in multiple countries.
- Completion of Phase 1 trials for MNKD-201, showing promise as a safer alternative for pulmonary fibrosis treatment.
Commitment to Innovation
With a passionate team and a robust pipeline, MannKind remains committed to revolutionizing drug delivery and improving patient outcomes. Its focus on inhaled therapeutics not only addresses unmet medical needs but also enhances the quality of life for patients worldwide.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in the Lytham Partners Spring 2022 Investor Conference taking place virtually from April 4-7, 2022. The company's presentation will be available on April 4 at 11:00 am ET and can be accessed on their website, with an archived version for later viewing. Management will also be available for one-on-one meetings during the event. MannKind focuses on developing inhaled therapies, including the FDA-approved Afrezza® inhalation powder, which is the first ultra-rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced that Chief Scientific Officer Thomas Hofmann will participate in the Cantor Virtual Rare Orphan Disease Summit on March 29, 2022, at 8:00 AM PT. The company specializes in developing inhaled therapeutic products for endocrine and orphan lung diseases, notably Afrezza (insulin human) Inhalation Powder, the only FDA-approved inhaled ultra-rapid-acting mealtime insulin available in the U.S. by prescription.
MannKind Corporation (Nasdaq: MNKD) will participate in the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 4:00 pm (ET). CEO Michael Castagna will deliver a virtual presentation accessible via the company’s website. MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, notably commercializing Afrezza® (insulin human) Inhalation Powder, the only inhaled ultra-rapid-acting mealtime insulin in the U.S. The webcast will be available for 14 days post-event.
MannKind Corporation (Nasdaq: MNKD) reported total revenues of $75.4 million for 2021, marking a 16% increase from 2020. Fourth quarter net revenue from Afrezza reached $11.3 million, up 13% year-over-year. Cash and investments stood at $260.7 million as of December 31, 2021. However, the company faced challenges, including a net loss of $80.9 million for the year and a significant increase in SG&A and R&D expenses. The review deadline for Tyvaso DPI has been extended to May 2022, impacting future revenue potential.
MannKind Corporation (Nasdaq: MNKD) announced that the FDA issued an information request to United Therapeutics regarding the New Drug Application for Tyvaso DPI. This request pertains to additional information on the pulmonary safety of the product, linked to a Citizen Petition. The FDA now considers the response a major amendment, extending the review deadline to May 2022. MannKind will discuss its 2021 financial results and updates in a conference call on February 24, 2022. Tyvaso DPI remains investigational and is not approved for any use.
MannKind Corporation (Nasdaq: MNKD) is set to release its 2021 fourth quarter and full year financial results on February 24, 2022, at 5:00 p.m. Eastern Time. The call will feature CEO Michael Castagna and CFO Steven Binder, discussing key financial outcomes and corporate updates. MannKind focuses on inhaled therapeutic products, notably the FDA-approved Afrezza®, an ultra rapid-acting mealtime insulin available nationwide in the U.S. and Brazil through partner Biomm SA.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in a Fireside Chat at the SVB Leerink 2022 Global Healthcare Conference on February 17, 2022, at 1:00 PM (ET). Interested parties can access the webcast through the Company’s website. MannKind is known for developing inhaled therapeutic products, including Afrezza®, an FDA-approved inhaled insulin that is available in the U.S. and Brazil. The webcast will be available for 14 days post-event.
MannKind Corporation (Nasdaq: MNKD) has announced that its CEO, Michael Castagna, PharmD, will present at the H.C. Wainwright Bioconnect Conference. The presentation will be available on demand starting January 10, 2022. Interested individuals can find the webcast link in the Events & Presentations section of the company’s website, where it will remain accessible for 14 days post-event.
The company specializes in inhaled therapeutic products for endocrine and orphan lung diseases, with its flagship product being Afrezza, the only inhaled ultra rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced the purchase of an additional convertible note from Thirona Bio, enhancing their collaboration initiated in June 2021 focused on FBM5712, a TGF-β inhibitor for pulmonary fibrosis. MannKind is advancing its inhaled formulation, MNKD-501, into a nonclinical PD study, with results expected in Q2 2022. CEO Michael Castagna has joined Thirona's board. Positive early signals from initial studies indicate potential efficacy, which could lead to further development and commercialization rights for treating fibrotic lung diseases.
MannKind Corporation (Nasdaq: MNKD) will participate in the Lytham Partners Winter 2021 Investor Conference from December 13-16, 2021. CEO Michael Castagna will host a webcasted Fireside Chat on December 13 at 11:00 AM ET to discuss the company's vision for 2022. Additionally, Castagna and CFO Steven B. Binder will hold 1x1 virtual investor meetings. The Fireside Chat will be available on the company's website and archived for replay. MannKind focuses on inhaled therapeutic products for endocrine and orphan lung diseases, with its lead product, Afrezza, being the only inhaled ultra-rapid acting insulin available in the U.S.
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