MannKind(MNKD)

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MannKind(MNKD) - 2024 Q3 - Quarterly Report
2024-11-07 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . | --- | --- | |----------------------------------------------------------------------------------------|------------------------------------------| | | | | | | ...
MannKind(MNKD) - 2024 Q3 - Quarterly Results
2024-11-07 21:05
EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2024 THIRD QUARTER FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Conference Call to Begin Today at 4:30 p.m. (ET) • 3Q 2024 Total revenues of $70M; +37% vs. 3Q 2023 • YTD 2024 Total revenues of $209M; +49% vs. YTD 2023 • YTD 2024 Net income of $20 million; Non-GAAP net income of $45 million • Orphan lung disease studies proceeding as planned o MNKD-101 Phase 3 clinical trial expands globally o MNKD-201 Phase 1 successfully completed; Plan to meet with FDA ...
MannKind to Present at 2024 UBS Healthcare Conference
GlobeNewswire News Room· 2024-11-05 21:15
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 05, 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 a fireside chat at the 2024 UBS Healthcare Conference in Rancho Palos Verdes, Calif. The ...
MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases
GlobeNewswire News Room· 2024-11-04 11:05
Core Insights - MannKind Corporation has successfully completed its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) [1][2] - The study demonstrated that nintedanib DPI was safe and well tolerated, with no typical adverse events associated with oral nintedanib reported [2][3] - The company plans to meet with the FDA in the first half of 2025 to discuss the Phase 1 trial results and the proposed late-stage development program for MNKD-201 [1][2] Study Results - Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers, with no gastrointestinal or neurologic adverse events reported [2][3] - Mild and transient adverse events included cough and a drop in FEV-1, which were not dose-dependent and did not show a pattern of recurrence [2][3] - The Phase 1 study was a single-site, randomized, placebo-controlled trial involving 40 healthy adult participants, focusing on safety, tolerability, and pharmacokinetics [2][3] Implications for Treatment - The findings support the advancement of nintedanib DPI as a potential treatment for patients with IPF, a disease with limited treatment options [2][3] - The delivery of a dry powder formulation directly to the lungs may reduce common adverse effects associated with oral nintedanib [3] - Preclinical chronic toxicology studies did not show adverse findings, further supporting the development of nintedanib DPI [3] Industry Context - Over 250,000 Americans are currently living with pulmonary fibrosis, with 50,000 new cases diagnosed each year [4] - IPF is one of the most common forms of pulmonary fibrosis, predominantly affecting men but increasingly seen in women [4] - MannKind Corporation focuses on developing innovative inhaled therapeutic products to address serious unmet medical needs in endocrine and orphan lung diseases [5][6]
MannKind Corporation (MNKD) Hits Fresh High: Is There Still Room to Run?
ZACKS· 2024-11-01 14:16
Have you been paying attention to shares of MannKind (MNKD) ? Shares have been on the move with the stock up 10.1% over the past month. The stock hit a new 52-week high of $7.15 in the previous session. MannKind has gained 94.2% since the start of the year compared to the 3.1% move for the Zacks Medical sector and the -2.7% return for the Zacks Medical - Biomedical and Genetics industry.What's Driving the Outperformance?The stock has an impressive record of positive earnings surprises, as it hasn't missed o ...
MannKind Corporation to Hold 2024 Third Quarter Financial Results Conference Call on November 7, 2024
GlobeNewswire News Room· 2024-10-31 20:05
Group 1 - MannKind Corporation will release its third quarter 2024 financial results after market close on November 7, 2024 [1] - A webcast to discuss the quarterly results and provide a business update will be hosted at 4:30 p.m. Eastern Time, featuring CEO Michael Castagna and CFO Chris Prentiss [2] - The webcast will be accessible on MannKind's website, with a replay available for approximately 90 days [2] Group 2 - MannKind focuses on developing and commercializing innovative inhaled therapeutic products for serious unmet medical needs, particularly in endocrine and orphan lung diseases [3] - The company aims to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension through its formulation and device engineering capabilities [4] - MannKind's technologies include dry-powder formulations and inhalation devices that enable rapid and convenient delivery of medicines [4]
First Site Initiated in Australia for MannKind's Phase 3 Clinical Trial Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease
GlobeNewswire News Room· 2024-10-31 01:00
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].
Why MannKind (MNKD) Could Beat Earnings Estimates Again
ZACKS· 2024-10-07 17:15
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) Just Overtook the 20-Day Moving Average
ZACKS· 2024-10-04 14:37
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 ...
MannKind Leverages Tyvaso DPI Strength In Pulmonary Market Expansion
Seeking Alpha· 2024-10-03 12:00
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 ...