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Mannkind Corporation - MNKD STOCK NEWS

Welcome to our dedicated page for Mannkind Corporation news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind Corporation stock.

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 Corporation (Nasdaq: MNKD) announced that the FDA issued a complete response to United Therapeutics regarding the New Drug Application (NDA) for Tyvaso DPI to treat pulmonary arterial hypertension and interstitial lung disease. The rejection was due to one open inspection issue at a third-party testing center, with no deficiencies found in MannKind's Connecticut facility. MannKind continues to build pre-launch inventory and plans to support United Therapeutics in securing NDA approval in the future.

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MannKind Corporation (Nasdaq: MNKD) announced the enrollment of its first pediatric patient in the INHALE-1 study, which aims to evaluate the efficacy and safety of Afrezza in children aged 4-17 with type 1 or type 2 diabetes. This multi-center, 26-week randomized trial will compare Afrezza in combination with basal insulin against multiple daily injections. The primary endpoint is the change in HbA1c levels after 26 weeks. Approximately 260 patients are expected to participate across over 30 U.S. sites, marking a significant step towards making Afrezza available for younger patients.

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MannKind Corporation (Nasdaq: MNKD) announced a sale-leaseback transaction with Creative Manufacturing Properties, expected to generate $102.25 million in gross proceeds. This strategic move allows MannKind to unlock capital from its manufacturing facility, supporting growth and development initiatives.

The transaction involves a 20-year lease for a 263,900 sq. ft. manufacturing space in Danbury, where MannKind produces its FDA-approved product, Afrezza. The company plans to utilize the funds to enhance its product pipeline and expand Afrezza's commercial activities.

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MannKind Corporation (Nasdaq: MNKD) announced its participation in the Lytham Partners Fall 2021 Investor Conference on October 5, 2021, at 11:45 am ET. CEO Michael Castagna, PharmD, will represent the company during the event. Interested parties can access a live webcast of the presentation through the Company’s website. MannKind focuses on developing inhaled therapeutic products, including Afrezza®, the only inhaled ultra rapid-acting insulin available in the U.S. The webcast replay will be available for 14 days post-event.

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MannKind Corporation (Nasdaq: MNKD) announced its participation in two upcoming conferences, featuring CEO Michael Castagna, PharmD as a presenter. The events include the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021, and the 2021 Cantor Global Virtual Healthcare Conference on September 27, 2021. Interested individuals can access live webcasts and replays on the company’s website for 14 days post-event. MannKind is known for developing inhaled therapeutic products, including Afrezza, an FDA-approved inhaled insulin available in the U.S. and Brazil.

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MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright 23rd Annual Global Investment Conference, available on demand from September 13, 2021. Interested parties can access the webcast through the Company’s Events & Presentations section on their website, where a replay will be available for 14 days. MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, including Afrezza®, the only inhaled ultra rapid-acting mealtime insulin in the U.S.

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United Therapeutics Corporation (Nasdaq: UTHR) showcased the BREEZE study results for Tyvaso DPI™ at the European Respiratory Society Congress 2021. This next-generation inhalation solution for pulmonary arterial hypertension (PAH) demonstrated significant safety and tolerability, with 96% completion rate in a three-week trial. Key findings included an 11.5-meter increase in six-minute walk distance and enhanced patient satisfaction with the device. The FDA is expected to review Tyvaso DPI's NDA in October 2021, which could enhance therapeutic accessibility for PAH patients.

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MannKind Corporation (MNKD) reported Q2 2021 revenues of $23.3 million, a 54% increase year-over-year, driven by Afrezza net revenue of $10.0 million. The company reported a net loss of $35.5 million, or $0.14 per share, compared to a net loss of $10.3 million in Q2 2020. Gross profit from Afrezza surged 68% to $5.6 million, enhancing gross margin to 56% (or 76% on a non-GAAP basis). Cash equivalents amounted to $201.4 million as of June 30, 2021, bolstered by $230 million in convertible notes issued earlier this year.

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NRx Pharmaceuticals has partnered with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil) for respiratory conditions. Utilizing MannKind's Technosphere® platform, the collaboration aims to create an inhalable delivery system that enhances patient convenience. ZYESAMI™ has shown promising results in clinical trials for COVID-19 patients. NRx has received Fast Track Designation from the FDA and is conducting phase 3 trials for both intravenous and inhaled formulations, funded by the NIH and BARDA.

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MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) to explore a dry powder formulation of ZYESAMI (aviptadil), aimed at treating respiratory failure due to COVID-19. Currently, ZYESAMI's intravenous formulation is in clinical trials with FDA Fast Track Designation. MannKind's CEO emphasized the potential of their Technosphere technology for delivering treatments effectively. The research is set to occur at MannKind's Danbury facility, which has significant production capabilities.

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FAQ

What is the current stock price of Mannkind Corporation (MNKD)?

The current stock price of Mannkind Corporation (MNKD) is $6.85 as of December 20, 2024.

What is the market cap of Mannkind Corporation (MNKD)?

The market cap of Mannkind Corporation (MNKD) is approximately 1.9B.

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

1.87B
270.76M
1.83%
56.64%
15.24%
Biotechnology
Pharmaceutical Preparations
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United States of America
DANBURY