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MannKind Corporation (Nasdaq: MNKD) is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative inhaled therapeutic products for patients with serious unmet medical needs. The company focuses on treating diseases such as diabetes, pulmonary arterial hypertension, and nontuberculous mycobacterial (NTM) lung disease.
Their flagship product, Afrezza, is an ultra-rapid-acting inhaled insulin designed to improve glycemic control in adults with diabetes. This product features a dry powder formulation of human insulin delivered via a small, portable inhaler.
MannKind's latest advancements include the initiation of a Phase 3 trial for Clofazimine Inhalation Suspension aimed at treating refractory NTM lung disease. The trial, named ICoN-1, will evaluate the efficacy and safety of the drug when added to standard therapy. This initiative is a response to the increasing global prevalence of NTM lung infections, which pose significant health risks and complications for patients.
Additionally, MannKind is progressing with a Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). This study will assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers.
The company's technological prowess is underlined by its proprietary Technosphere® dry-powder technology, which facilitates rapid and effective delivery of medicines to the deep lung. This technology, combined with their inhalation devices, is used to develop new treatments that can either act locally in the lungs or enter the systemic circulation, depending on the medical need.
In a strategic partnership, MannKind has in-licensed Pulmatrix's iSPERSE™ technology to enhance their formulation capabilities. This collaboration also includes exchanging MannKind's Cricket® inhaler technology to aid in the development of inhaled treatments for migraine and other neurological diseases.
Financially, MannKind continues to invest in R&D to expand its product pipeline and enhance its technological platforms. The company’s partnerships, such as the recent agreement with Pulmatrix, are also set to strengthen MannKind's market position in the biopharmaceutical landscape.
With a dedicated team and a robust pipeline, MannKind Corporation remains at the forefront of developing effective inhaled therapies, striving to improve patient outcomes and quality of life.
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.
MannKind Corporation (MNKD) reported a 45% increase in total revenues to $22.2 million for Q3 2021, driven by Afrezza net revenue of $9.8 million, up 34% year-over-year. Collaboration revenue also rose 54% to $12.5 million. Gross profit increased 61% to $5.9 million, leading to a gross margin improvement to 61% from 51%. Despite these gains, the net loss was $4.4 million or $0.02 per share, down from $11.3 million in the prior year. Cash equivalents stood at $181.1 million as of September 30, 2021.
MannKind Corporation (Nasdaq: MNKD) announced the completion of a sale-leaseback transaction that generated $102.25 million in non-dilutive gross proceeds on November 8, 2021. This deal involves the sale of 263,900 square feet of manufacturing space in Danbury, Conn., while MannKind retains operational control of its facilities. The company manufactures Afrezza® (inhaled insulin) and Tyvaso DPI™ (inhaled treprostinil) at this location. MannKind also signed a 20-year lease with renewal options, allowing continued operations without the burden of ownership.
MannKind Corporation (Nasdaq: MNKD) is set to present promising findings regarding its Technosphere® Insulin (TI) at the 21st Annual Diabetes Technology Meeting on November 11. This feasibility study highlights that a TI dose—approximately double the standard mealtime subcutaneous injection—significantly reduced postprandial glucose excursions without causing severe hypoglycemia. Specifically, the maximum mean postprandial glucose dropped from 234 to 186 mg/dL, demonstrating a 50 mg/dL improvement at 120 minutes.
MannKind Corporation (Nasdaq:MNKD) will announce its third quarter financial results on November 9, 2021, at 5:00 PM ET. CEO Michael Castagna and CFO Steven B. Binder will discuss the financial performance and corporate updates during a conference call. The call will be available for live listening on the company’s website, with a replay accessible for 14 days. MannKind specializes in developing inhaled therapeutic products, including Afrezza, the only FDA-approved inhaled ultra rapid-acting mealtime insulin in the U.S. More information can be found on their corporate site.
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