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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) will announce its Q2 2021 financial results on August 11, 2021, at 5 PM ET. The conference call will feature insights from CEO Michael Castagna and CFO Steven B. Binder. Investors can access the call and the subsequent replay on MannKind's website. MannKind focuses on inhaled therapeutic products, notably the FDA-approved Afrezza, the only inhaled ultra-rapid-acting insulin available in the U.S. and Brazil. The company was founded in 1991 and is based in Westlake Village, California.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference on August 10, 2021, at 12:30 PM (ET). This event is exclusive to BTIG clients. MannKind focuses on developing and marketing inhaled therapies for patients with endocrine and orphan lung diseases. Its leading product is Afrezza®, the only inhaled ultra-rapid-acting mealtime insulin available in the U.S. for prescription.
MannKind Corporation (Nasdaq: MNKD) is partnering with U.S. professional racing driver Conor Daly, who has Type 1 diabetes, to engage local youth during the Music City Grand Prix week. Scheduled for August 4, 2021, Daly will share his diabetes journey and racing tips while racing go-karts with participants. Known for his resilience, Daly was diagnosed at 14 yet has competed successfully in over 70 Indy car races. This initiative aims to inspire youth and raise awareness of living with diabetes, emphasizing that it should not limit one's aspirations.
MannKind Corporation (Nasdaq: MNKD) announced a positive policy change by the Centers for Medicare and Medicaid Services (CMS) effective July 18, 2021. This change to the Local Coverage Determination (LCD) L33822 allows Medicare patients with diabetes to use both Afrezza® and Continuous Glucose Monitors (CGMs) simultaneously. Previously, patients had to choose between the two, which resulted in Medicare denials. MannKind's CEO emphasized the importance of patient convenience, while experts anticipate broader access for Afrezza users, enhancing diabetes management options.
MannKind Corporation (Nasdaq: MNKD) presented two posters at the American Diabetes Association's virtual 81st Scientific Sessions from June 25-29, focusing on its inhaled insulin, Afrezza®. Poster 923-P details a Phase 2 clinical study demonstrating the pharmacokinetics and safety of Afrezza in pediatric patients with type 1 diabetes, showing no severe hypoglycemic events. Poster 722-P presents findings from a Levin study indicating that Afrezza helps reduce hyperglycemia in patients with uncontrolled type 2 diabetes, improving daytime time-in-range by 83.5%. MannKind is set to initiate a Phase 3 study in fall 2021.
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™. This inhaled treatment addresses pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is set to conclude by October 2021, with no identified review issues thus far. This marks the second FDA review for a product developed using MannKind's Technosphere® technology, following the approved Afrezza®.
MannKind Corporation (Nasdaq: MNKD) announces the FDA's acceptance of the NDA for Tyvaso DPI™, intended for pulmonary arterial hypertension treatment. The priority review is expected to complete by October 2021, with no identified review issues so far. This advancement follows the company's collaboration with United Therapeutics to develop Tyvaso DPI, using MannKind’s Technosphere® technology. Additionally, MannKind is expanding its manufacturing facility in Connecticut, planning to hire over 100 employees to support the pre-launch inventory of Tyvaso DPI.
United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™ to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is expected to conclude by October 2021, with no identified review issues so far. Tyvaso DPI is a next-generation dry powder formulation, promising improved administration methods compared to traditional nebulization. The NDA includes data from the BREEZE study, which demonstrated the safety and tolerability of Tyvaso DPI.
MannKind Corporation (Nasdaq: MNKD) has partnered with Thirona Bio, Inc. for the development of FBM5712, a small molecule inhibitor targeting TGF-β for pulmonary fibrosis treatment. MannKind will conduct formulation and preclinical studies on this compound, which has potential applications for various fibrotic diseases. As part of the agreement, MannKind purchased a convertible note to support Thirona's financing. This collaboration aligns with MannKind's goal of launching new products annually from 2025 to 2030, amplifying its pipeline in pulmonary and dermatological conditions.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the Lytham Partners Summer 2021 Investor Conference on June 14, 2021, at 11:45 AM (ET). Attendees can access the webcast link on the Company's website, where a replay will be available for 14 days post-presentation. MannKind specializes in developing inhaled therapeutic products, including its FDA-approved product, Afrezza®, an inhaled ultra-rapid-acting mealtime insulin, available in the U.S. and Brazil.
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