Welcome to our dedicated page for Mannkind news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind stock.
MannKind Corporation (Nasdaq: MNKD) generates frequent news across product, clinical, regulatory, and corporate fronts as it advances therapies for cardiometabolic and orphan lung diseases. News coverage for MNKD often centers on its commercial products Afrezza, FUROSCIX, V-Go, and Tyvaso DPI–related collaborations, as well as updates on its inhaled and subcutaneous pipeline.
Investors and healthcare observers following MNKD news can expect announcements on U.S. Food and Drug Administration (FDA) milestones, including supplemental Biologics License Applications and supplemental New Drug Applications. Recent examples include FDA acceptance for review of an sBLA for Afrezza in children and adolescents with type 1 or type 2 diabetes, and acceptance of an sNDA for the FUROSCIX ReadyFlow Autoinjector for edema in adults with chronic heart failure or chronic kidney disease.
MannKind’s news flow also covers clinical trial progress and portfolio decisions in orphan lung diseases. The company has reported on initiation of nintedanib DPI (MNKD-201) studies for idiopathic pulmonary fibrosis, as well as the discontinuation of the Phase 3 ICoN-1 trial of nebulized clofazimine (MNKD-101) for refractory nontuberculous mycobacterial lung disease following a futility analysis. Updates on pre-clinical programs such as bumetanide DPI and MNKD-102 are also featured in its communications.
Corporate and financial news items include quarterly earnings results, revenue breakdowns across royalties, collaborations, and product sales, and strategic transactions. A notable example is MannKind’s acquisition of scPharmaceuticals, which brought FUROSCIX fully into its portfolio and expanded its presence in cardiometabolic care. The company also issues releases about investor conference presentations and community initiatives, such as the Centennial Al Mann Scholarship for students living with diabetes.
This news page aggregates these developments so readers can review regulatory decisions, trial outcomes, business combinations, and financial updates related to MannKind in one place.
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.
MannKind (Nasdaq: MNKD), a company developing inhaled therapeutic products for endocrine and orphan lung diseases, has announced its participation in three upcoming investor conferences. CEO Michael Castagna and CFO Chris Prentiss will present at:
- 2024 Wells Fargo Healthcare Conference in Boston on September 4 at 11:00 a.m. ET
- Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 6 at 7:00 a.m. ET
- H.C. Wainwright 26th Annual Global Investment Conference in New York on September 10 at 9:30 a.m. ET
Live audio webcasts will be available on MannKind's website, with recordings accessible for about 30 days after each conference.
MannKind (Nasdaq: MNKD) has announced significant changes to its Board of Directors. Kent Kresa, who has served on the board since June 2004 and was Chairman from 2016 to 2020, will retire effective September 30, 2024. He will continue as Chairman Emeritus. Steven B. Binder, the company's former Chief Financial Officer, will join the board on the same date.
Binder, who served as CFO from July 2017 to April 2024, is currently Executive Vice President of Special Projects. He will step down from this role when he joins the board. James S. Shannon, current Chairman, praised Kresa's two decades of leadership and expressed enthusiasm for Binder's appointment, citing his financial stewardship and role in diversifying MannKind's revenue streams. The board will maintain nine members following these changes.
MannKind (MNKD) reported strong financial results for Q2 2024, with total revenues of $72M, up 49% year-over-year. The company achieved its ninth consecutive quarter of revenue growth, approaching an annual revenue run rate of over $275 million. Key highlights include:
- Royalties from Tyvaso DPI increased 34% to $25.6M
- Collaborations and services revenue up 132% to $26M
- Afrezza net revenue grew 20% to $16.3M
- YTD 2024 net income of $9M; Non-GAAP net income of $29M
MannKind also made progress on its clinical pipeline, initiating Phase 3 trials for MNKD-101 and Phase 1 trials for MNKD-201. The company remains focused on its diversification strategy, allocating capital towards pipeline development, in-line growth, and debt reduction.
MannKind (Nasdaq: MNKD) has launched an educational website, LearnAboutNTM.com, to raise awareness of nontuberculous mycobacterial (NTM) lung disease. The launch coincides with World NTM Awareness Day on August 4. NTM lung disease is a rare condition caused by naturally occurring bacteria that can lead to serious lung damage in susceptible individuals.
Key points:
- NTM affects nearly 100,000 people in the U.S. and over 150,000 in Japan
- Prevalence is increasing globally, with a 7.5% annual rise in the U.S.
- The disease is more common in women over 65
- MAC (mycobacterium avium complex) accounts for 80% of NTM cases in the U.S.
- 15-20% of NTM patients are refractory to treatment
The website aims to promote early detection and provide resources for patients and caregivers.
MannKind (Nasdaq: MNKD) has announced that it will release its second quarter 2024 financial results on Wednesday, August 7, 2024, before the market opens. The company will issue a press release detailing the quarterly results approximately one hour before hosting a webcast at 9:00 a.m. Eastern Time.
The webcast, accessible to investors, media, and the general public, will feature CEO Michael Castagna and CFO Chris Prentiss. Interested parties can access the webcast through MannKind's website at https://investors.mannkindcorp.com/events-and-presentations. A replay will be available in the same location within 24 hours after the call and remain accessible for about 90 days.
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.
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.
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.