DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Oct. 31, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), announced today that its third quarter 2024 financial results will be released after market close on Thursday, November 7, 2024. MannKind will host a webcast beginning at 4:30 p.m. Eastern Time to discuss the quarterly results and provide a business update. Participating in the conference call from MannKind will be Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer C ...

Core Viewpoint - MannKind Corporation has initiated its Phase 3 clinical trial, ICoN-1, for Clofazimine Inhalation Suspension targeting nontuberculous mycobacterial lung disease, with regulatory approvals in multiple countries [1][2][5]. Group 1: Clinical Trial Details - The ICoN-1 study is a multinational, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Clofazimine Inhalation Suspension in adults with refractory NTM lung disease caused by mycobacterium avium complex (MAC) [4]. - Approximately 230 eligible participants will be enrolled across more than 100 sites globally, with a target of at least 180 evaluable participants for efficacy [3]. - The primary endpoint is sputum culture conversion from baseline to the end of Month 6, with a co-primary endpoint in the U.S. focusing on quality of life changes during the same period [4]. Group 2: Regulatory and Patent Information - The U.S. FDA granted Fast Track designation for Clofazimine Inhalation Suspension, which is also recognized as an orphan drug and a qualified infectious disease product (QIDP), potentially providing up to 12 years of market exclusivity [5]. - A patent covering compositions of Clofazimine and methods for treating lung infections has been granted, with expiration set for June 8, 2039 [6]. Group 3: NTM Disease Context - Nontuberculous mycobacterial (NTM) lung infection is a rare but growing global health concern, with an estimated prevalence of over 100,000 cases in the U.S. and over 150,000 in Japan as of 2022 [8]. - The prevalence of NTM is increasing globally, with claims-based studies in the U.S. suggesting an annual rise of 7.5% [8]. - The most common type of NTM lung disease is caused by MAC, accounting for about 80% of cases in the U.S., particularly affecting women over 65 [8].

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? MannKind (MNKD) , which belongs to the Zacks Medical - Biomedical and Genetics industry, could be a great candidate to consider.This biopharmaceutical company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 275%.For the last reported quarter, M ...

MannKind (MNKD) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, MNKD broke through the 20-day moving average, which suggests a short-term bullish trend.A well-liked tool among traders, the 20-day simple moving average offers a look back at a stock's price over a 20-day period. This is very beneficial to short-term traders, as it smooths out short-term price trends and gives more trend reversal signals than longer-term moving averages.Simila ...

I specialize in biotech and healthcare investment analysis, integrating clinical expertise with a solid foundation in business strategy. My approach leverages detailed risk-return charts and DCF analyses to clearly communicate the investment potential and associated risks. I advocate for a barbell portfolio strategy, with 90% allocated to secure assets such as Treasuries and broad-market ETFs, and 10% to high-alpha stocks. This balanced approach ensures that all recommendations are made within a context of ...

Core Insights - MannKind Corporation announced positive 30-week results from the Phase 4 INHALE-3 study, showing that more patients with type 1 diabetes achieved target A1c levels when using Afrezza compared to usual care [1][3] Study Overview - The INHALE-3 study is a randomized controlled trial that included a 17-week phase followed by a 13-week extension, conducted across 19 U.S. sites with 141 enrolled patients [3][4] - Participants were adults with type 1 diabetes using multiple daily injections, automated insulin delivery systems, or pumps without automation, assigned to either continue standard care or switch to Afrezza [3][4] Key Findings - The extension phase showed a 100% increase in the number of subjects achieving A1c levels below 7% at 30 weeks in the Afrezza-treated group compared to baseline [1] - The study met its primary efficacy endpoint at 17 weeks, demonstrating non-inferiority in HbA1c change between the Afrezza group and the usual care group [4] - In the extension phase, 45 subjects from the inhaled insulin group and 49 from the usual care group transitioned to Afrezza, with 43 and 42 completing the study respectively [4] Future Outlook - MannKind Corporation plans to present more detailed results from the 30-week study at the ATTD conference in March 2025 [3]

Clearance to proceed also received from health authorities in South Korea and Australia, with Taiwan expected in 4Q 2024First U.S. patient randomized DANBURY, Conn., Sept. 18, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PM ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Chief Financial Officer Chris Prentiss and Dr. Wasim Fares Therapeutic Area Head, Orphan Lung Diseases, will share updates during a fireside chat at the 2024 Cantor Fitzgerald Global Healthcare Conference i ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during fireside chats at three upcoming investor conferences: 2024 Wells Fargo Healthcare Confe ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Kent Kresa has decided to retire from MannKind’s Board of Directors effective September 30, 2024. In addition, the Board of Directors has appointed Steven B. Binder to the Board, also effective September 30, ...