Study proves inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpointPatients utilizing inhaled insulin reached target A1c (less than 7%) 30% of the time compared to 17% with usual care and 24% had time-in-range (TIR) above 70% with no increased hypoglycemia compared with 13% with usual careMore than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza® ...

17-week endpoint results comparing Afrezza® head-to-head with multiple daily injections (MDI) and insulin pumpsINHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 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 e ...

Core Insights - MannKind Corporation announced the presentation of 17-week endpoint results from the INHALE-3 study at the American Diabetes Association's 84th Scientific Sessions on June 22, 2024 [1][2] - The study compares the efficacy and safety of inhaled insulin Afrezza with multiple daily injections (MDI) and insulin pumps in adults with Type 1 diabetes [2] Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products for endocrine and orphan lung diseases [3][4] - The company aims to address serious unmet medical needs through its dry-powder formulations and inhalation devices, providing rapid and convenient delivery of medications [4] Study Details - The INHALE-3 study is the largest post-market clinical trial conducted by MannKind in the last decade, with results expected to clarify how inhaled insulin compares to usual care [2] - The symposium will feature various presentations, including study methods, results, and critiques from experts in the field [2]

Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D spaceNon-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind's Cricket® inhaler DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 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 di ...

Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D spaceNon-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind’s Cricket® inhaler DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 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 d ...

MannKind (MNKD) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a changing earn ...

Financial Data and Key Metrics Changes - Total revenues grew by 63% year-over-year, marking the eighth consecutive quarter of revenue growth [18][24] - GAAP net income for Q1 2024 was $11 million, representing a significant increase compared to previous quarters [20][24] - Cash at the end of Q1 2024 was $304 million, up by $2 million from the previous quarter [6][24] Business Line Data and Key Metrics Changes - Tabesa DPI revenue reached almost $48 million, driven by strong sales and record production [5][18] - The diabetes business saw a 7% year-over-year volume growth, with Afrezza growing 7% while V-GO sales dropped by 16% to $4 million [6][11][19] - Collaboration and services revenue increased by 118% to $25 million, attributed to higher production activity and sales [18] Market Data and Key Metrics Changes - The inhaled insulin market is expected to continue growing, with MannKind targeting a $1 billion opportunity in orphan lung diseases [7] - The company anticipates significant revenue potential from the Tabesa DPI product, estimating $300 million to $350 million for every 10,000 patients covered [30] Company Strategy and Development Direction - MannKind is focusing on expanding its inhaled insulin product line and addressing rare orphan lung diseases [4][30] - The company plans to invest in clinical trials for MannKind-101 and MannKind-201, with fast-track designations from the FDA [22][29] - The strategy includes enhancing the commercial model for Afrezza and exploring international market opportunities [16][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued revenue growth and the potential for new product approvals in the near future [4][29] - The company is positioned well financially, having reduced debt and improved cash flow, which supports ongoing investments in growth initiatives [23][24] - Management highlighted the importance of upcoming clinical trial results and their potential impact on future product launches [29][61] Other Important Information - The company has undergone significant transformation, with a focus on improving the lives of patients with diabetes and orphan lung diseases [27][28] - Upcoming scientific conferences and shareholder meetings are planned to enhance engagement and communication with stakeholders [32] Q&A Session Summary Question: Expectations for INHALE-3 readout at ADA in June - Management clarified that the goal is to demonstrate that Afrezza is as effective as the best standard of care for Type-1 diabetes, with a focus on mealtime control [35][36] Question: Path forward for MannKind-201 in IPF - Management indicated that they are confident in the trial's execution and do not see a need for a partner at this stage, focusing on independent progress [42][44] Question: Next milestones for Afrezza and potential filing timelines - Management discussed the possibility of filing for approval based on six months of data, depending on the results from ongoing trials [46][48] Question: Sustainability of revenue growth from collaboration - Management noted that increased production and sales to United Therapeutics are expected to continue, with recurring revenue from ongoing projects [49][51]

For the quarter ended March 2024, MannKind (MNKD) reported revenue of $66.26 million, up 63.1% over the same period last year. EPS came in at $0.05, compared to -$0.04 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $58.25 million, representing a surprise of +13.76%. The company delivered an EPS surprise of +150.00%, with the consensus EPS estimate being $0.02.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how ...

MannKind (MNKD) came out with quarterly earnings of $0.05 per share, beating the Zacks Consensus Estimate of $0.02 per share. This compares to loss of $0.04 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 150%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced earnings of $0.02, delivering a surprise of 300%.Over the last four quarters, the company ...

1Q 2024 Total revenues of $66M; +63% vs. 1Q 20231Q 2024 Net income of $11M; Non-GAAP net income of $15M$304M of cash and cash equivalents and investments at March 31, 2024In early April, repaid Midcap senior-secured debt and Mann Group convertible debt totaling approximately $37M FDA Fast Track designation and IND clearance received for MNKD-101 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter en ...