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MannKind Corporation - MNKD STOCK NEWS

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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.

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MannKind (Nasdaq: MNKD) announced positive results from its INHALE-3 Phase 4 clinical trial, comparing inhaled insulin Afrezza with usual care for adults with Type 1 Diabetes (T1D). The 17-week study, presented at the American Diabetes Association's 84th Scientific Sessions, met its primary efficacy endpoint, showing non-inferior HbA1c levels with inhaled insulin. Key findings include 30% of the Afrezza group achieving HbA1c <7% versus 17% in the usual care group, and 24% reaching >70% Time-in-Range (TIR) with no increased hypoglycemia. Over 50% expressed interest in continuing Afrezza. The study supports inhaled insulin as a viable T1D treatment option.

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MannKind will present the 17-week endpoint results of the INHALE-3 study at the ADA's 84th Scientific Sessions on June 22, 2024. The study compares Afrezza, an inhaled insulin, with multiple daily injections and insulin pumps in adults with Type 1 diabetes. The presentation, featuring Dr. Irl B. Hirsh and moderated by Dr. Roy W. Beck, will include various insights into the efficacy, safety, and quality of life outcomes of Afrezza. This event marks the largest post-market clinical trial for Afrezza in the past decade. Full results will be available later this year.

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MannKind (Nasdaq: MNKD) announced a non-cash transaction with Pulmatrix, obtaining a license for Pulmatrix's iSPERSE™ technology and an upgraded Boston-area R&D facility. In exchange, Pulmatrix will receive MannKind's Cricket® inhaler for DHE delivery. The iSPERSE technology will be used for clofazimine, NTM, and insulin, and for certain endocrine and lung diseases. This move aims to strengthen MannKind's capacity for formulation and asset development, leveraging both companies' technological advancements. The transaction is expected to finalize in July 2024.

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Pulmatrix announced a series of transactions with MannKind involving a cross-license agreement and transfer of laboratory assets. Pulmatrix's iSPERSE™ technology will be licensed to MannKind, while Pulmatrix gains access to MannKind's Cricket® inhalation device for its PUR3100 formulation, aimed at treating acute migraine. Additionally, MannKind will assume Pulmatrix's lease for its Bedford, Mass. R&D facility, extending Pulmatrix's cash runway into 2026. The agreement, expected to close in July 2024, also includes a master service arrangement for MannKind to provide future dry powder drug formulation services to Pulmatrix.

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MannKind reported strong financial results for the first quarter of 2024, with total revenues reaching $66 million, marking a 63% increase from the previous year. The company also achieved a net income of $11 million, with $304 million in cash and investments as of March 31, 2024. MannKind received Fast Track designation and IND clearance for MNKD-101, showcasing progress in their clinical development. Moreover, the company highlighted revenue growth, margin improvements, and advancements in their product pipeline, positioning them for a successful year ahead.

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MannKind (MNKD) has received Fast Track designation from the FDA for Clofazimine Inhalation Suspension for the treatment of NTM lung disease. This designation aims to speed up the review process for important medicines addressing unmet medical needs. The company is optimistic about the ICoN-1 study and the potential benefits for patients with NTM. The drug has also received orphan drug and QIDP designations, potentially providing up to 12 years of market exclusivity.

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MannKind (Nasdaq: MNKD) will host a conference call to discuss its 2024 first quarter financial results on May 8, 2024. Interested parties can listen live on the Company's website.

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MannKind (Nasdaq: MNKD) has announced the initiation of a Phase 1 study for nintedanib DPI (MNKD-201) targeting pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). This study will assess safety, tolerability, and pharmacokinetics in healthy volunteers, with enrollment expected to commence in June 2024. The company aims to provide potential treatment options for patients with serious lung diseases, following their ongoing Phase 3 study of Clofazimine Inhalation Suspension for nontuberculous mycobacterial (NTM) lung diseases.

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MannKind has received clearance from the U.S. FDA to start a Phase 3 study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease. The IND clearance enables the company to initiate a Phase 3 trial to evaluate the efficacy and safety of Clofazimine Inhalation Suspension in treating refractory NTM lung disease caused by Mycobacterium Avium Complex (MAC). This study, identified as ICoN-1, is set to begin by the end of the second quarter of 2024 in the U.S. and later in the second half of 2024 internationally. NTM lung disease is becoming increasingly prevalent worldwide, with significant impact on patients' lives and rising annual growth rates.

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MannKind (MNKD) has repaid its credit and security agreement with MidCap Financial Trust and convertible note issued to Mann Group in full, reducing total debt by approximately $41.8 million. The repayment includes $31.6 million to MidCap Financial Trust and exchange for 1.5 million shares of common stock and $8.9 million to Mann Group CEO Michael Castagna highlighted the elimination of expensive debt and undervaluation of the stock.
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FAQ

What is MannKind Corporation's primary focus?

MannKind Corporation primarily focuses on the development and commercialization of innovative inhaled therapeutic products for diseases such as diabetes, pulmonary arterial hypertension, and nontuberculous mycobacterial (NTM) lung disease.

What is Afrezza?

Afrezza is MannKind's ultra-rapid-acting inhaled insulin used to improve glycemic control in adults with diabetes. It consists of a dry powder formulation of human insulin delivered via a small, portable inhaler.

What recent advancements has MannKind made?

MannKind recently announced the initiation of a Phase 3 trial for Clofazimine Inhalation Suspension for NTM lung disease and a Phase 1 study for nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases.

What is Technosphere<sup>®</sup> technology?

Technosphere® technology is MannKind's proprietary dry-powder inhalation platform that provides rapid and effective delivery of medicines to the deep lung for local or systemic effects.

What is the significance of the iSPERSE<sup>™</sup> technology partnership?

The in-licensing of Pulmatrix's iSPERSE technology allows MannKind to enhance its formulation capabilities for developing effective inhaled therapies, particularly for diseases requiring higher drug payloads.

What diseases does MannKind target with its products?

MannKind targets endocrine diseases such as diabetes and various orphan lung diseases including NTM lung disease, pulmonary fibrosis, and pulmonary arterial hypertension.

Where can I find more information about MannKind Corporation?

More information about MannKind Corporation can be found on their website, mannkindcorp.com, and their social media channels on LinkedIn, Facebook, X, and Instagram.

Is MNKD-101 approved for use?

No, MNKD-101 is an investigational product and is not approved for any use in any country at this time.

What is the significance of the ICoN-1 trial?

The ICoN-1 trial is a Phase 3 study evaluating the efficacy and safety of Clofazimine Inhalation Suspension for treating refractory NTM lung disease. It aims to address a rising global health concern and improve treatment options for this serious condition.

How does MannKind's partnership with Pulmatrix benefit its R&D capabilities?

The partnership with Pulmatrix includes acquiring Pulmatrix’s R&D facility, allowing MannKind to expand its presence in the Boston area and continue advancing its orphan lung disease programs with enhanced capabilities.

MannKind Corporation

Nasdaq:MNKD

MNKD Rankings

MNKD Stock Data

1.59B
272.32M
2.04%
50.28%
13.13%
Pharmaceutical Preparation Manufacturing
Manufacturing
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United States of America
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