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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 (MNKD) has announced significant debt restructuring through exchange agreements with certain holders of its 2.50% Convertible Senior Notes due 2026. The company will exchange approximately $193.7 million of Notes for 26,749,559 shares of common stock and make a cash payment of $89.2 million to the holders.
This transaction reduces MannKind's total outstanding debt by 84%, decreasing from $230 million to approximately $36.3 million. The exchange will save approximately 10.4 million shares of potential dilution and reduce annual interest expense by $4.9 million to $0.9 million. Following the exchange, MannKind's cash balance will exceed $180 million with approximately 302.5 million shares outstanding.
MannKind (MNKD) announced six-month results from its Phase 3 INHALE-1 study of Afrezza (inhaled insulin) in children and adolescents aged 4-17 years. The 26-week trial involved 230 subjects randomized to either Afrezza or multiple daily injections (MDI) of rapid-acting insulin.
The modified intent-to-treat (mITT) analysis, excluding one non-adherent patient, demonstrated non-inferiority of Afrezza to MDI with a between-group difference of 0.370% in HbA1c change, meeting the primary endpoint's threshold of 0.4%. No significant differences in lung function or safety parameters were observed between groups. The company plans to meet with FDA regarding a potential supplemental new drug application (sNDA) submission in first half of 2025.
MannKind (MNKD) announced that India's Central Drugs Standard Control Organisation (CDSCO) has approved Afrezza (insulin human) Inhalation Powder for adults. This approval follows existing approvals in the United States and Brazil. The company expects to ship the product to their partner Cipla by the end of 2025.
This milestone is particularly significant as India has the second-highest burden of diabetes worldwide, with over 74 million people affected. The partnership between MannKind and Cipla, established in May 2018, involves Cipla handling regulatory approvals, marketing, and sales in India, while MannKind is responsible for product supply.
According to the International Diabetes Federation, diabetes affects 537 million adults globally, with projections reaching 643 million by 2030 and 783 million by 2045.
MannKind (MNKD) reported strong financial results for Q3 2024, with total revenues reaching $70 million, up 37% from Q3 2023. Year-to-date revenues reached $209 million, a 49% increase from the previous year. The growth was primarily driven by Tyvaso DPI revenues, with royalties increasing 34% to $27.1 million. Afrezza net revenue grew 12% to $15 million. The company achieved a net income of $20 million year-to-date and reported significant progress in clinical trials, including MNKD-101 Phase 3 expansion and successful completion of MNKD-201 Phase 1.
MannKind (Nasdaq: MNKD) has announced its participation in the 2024 UBS Healthcare Conference in Rancho Palos Verdes, California. CEO Michael Castagna and CFO Chris Prentiss will participate in a fireside chat on Tuesday, November 12, at 10:15 a.m. Pacific Time. The company, which specializes in developing inhaled therapeutic products for endocrine and orphan lung diseases, will provide company updates during the session. The presentation will be accessible via live audio webcast on MannKind's website, with a recorded version available for approximately 30 days after the event.
MannKind (MNKD) announced successful completion of Phase 1 trial for nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases. The trial met its primary objective, demonstrating safety and tolerability in healthy volunteers. Key highlights include absence of typical adverse events associated with oral nintedanib, particularly GI and neurologic events. Only mild, transient adverse events were noted - cough and FEV-1 drop, which fully recovered. The study included single and multiple-ascending doses in adults over 40 years. The company plans to meet with FDA in first half of 2025 to discuss late-stage development.
MannKind (Nasdaq: MNKD) has scheduled its third quarter 2024 financial results release for Thursday, November 7, 2024, after market close. The company will host a webcast at 4:30 p.m. Eastern Time to discuss quarterly results and provide a business update. CEO Michael Castagna and CFO Chris Prentiss will lead the conference call. The webcast will be available on MannKind's investor relations website, with a replay accessible for approximately 90 days.
MannKind (Nasdaq: MNKD) announced positive 30-week results from its Phase 4 INHALE-3 study for Afrezza®, an inhaled insulin for type 1 diabetes. The study showed that more adults achieved target A1c levels (<7%) when switching to or remaining on Afrezza plus basal insulin, compared to usual care (multiple daily injections or insulin pumps).
Key findings include:
- 100% increase in subjects achieving A1c <7% at 30 weeks in the Afrezza-treated group from baseline
- More than double the subjects achieved A1c <7% at week 30 after switching from usual care to Afrezza at week 17
The company plans to present detailed results at upcoming conferences, including ATTD in March and additional events in 2025.
MannKind (Nasdaq: MNKD) has received clearance from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 clinical trial (ICoN-1) of Clofazimine Inhalation Suspension for treating nontuberculous mycobacterial (NTM) lung disease. The global study is now cleared in four countries: U.S., Japan, South Korea, and Australia, with Taiwan expected in Q4 2024. The first U.S. patient has been randomized.
The ICoN-1 study aims to enroll approximately 230 eligible participants across more than 100 sites globally, ensuring at least 180 participants are evaluable for efficacy. Dr. Kozo Morimoto, lead principal investigator for ICoN-1 in Japan, emphasized the importance of developing potential therapies for the rising number of NTM lung infections in Japan and globally.
MannKind (Nasdaq: MNKD), a company specializing in inhaled therapeutic products for endocrine and orphan lung diseases, will participate in the 2024 Cantor Fitzgerald Global Healthcare Conference in New York. Chief Financial Officer Chris Prentiss and Dr. Wasim Fares, Therapeutic Area Head for Orphan Lung Diseases, will present during a fireside chat on Wednesday, September 18 at 1:20 p.m. Eastern Time.
The presentation will be accessible via a live audio webcast on MannKind's website, with a recorded version available for approximately 30 days after the event. This conference provides an opportunity for MannKind to share updates on their innovative therapeutic products and connect with healthcare industry professionals.
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