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 (MNKD) specializes in innovative inhaled therapies for diabetes and respiratory diseases, notably through its FDA-approved Afrezza® inhaled insulin. This page aggregates official announcements, clinical trial updates, and strategic partnership news critical for understanding the company's trajectory.
Investors and researchers will find curated press releases covering financial results, regulatory milestones, and technology licensing agreements. The collection emphasizes developments in MannKind's core platforms: the Technosphere® drug delivery system and iSPERSE™ formulation technology.
Content includes updates on pulmonary arterial hypertension treatments, diabetes management solutions, and global expansion initiatives. All materials maintain factual accuracy without speculative analysis, adhering to financial disclosure standards.
Bookmark this page for streamlined access to MNKD's latest business developments and scientific advancements. Verify time-sensitive details directly through company filings or official communications.
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.
Pulmatrix announced a series of transactions with MannKind involving a cross-license agreement and transfer of laboratory assets. Pulmatrix's iSPERSE™ technology will be licensed to MannKind, while Pulmatrix gains access to MannKind's Cricket® inhalation device for its PUR3100 formulation, aimed at treating acute migraine. Additionally, MannKind will assume Pulmatrix's lease for its Bedford, Mass. R&D facility, extending Pulmatrix's cash runway into 2026. The agreement, expected to close in July 2024, also includes a master service arrangement for MannKind to provide future dry powder drug formulation services to Pulmatrix.
MannKind reported strong financial results for the first quarter of 2024, with total revenues reaching $66 million, marking a 63% increase from the previous year. The company also achieved a net income of $11 million, with $304 million in cash and investments as of March 31, 2024. MannKind received Fast Track designation and IND clearance for MNKD-101, showcasing progress in their clinical development. Moreover, the company highlighted revenue growth, margin improvements, and advancements in their product pipeline, positioning them for a successful year ahead.
MannKind (MNKD) has received Fast Track designation from the FDA for Clofazimine Inhalation Suspension for the treatment of NTM lung disease. This designation aims to speed up the review process for important medicines addressing unmet medical needs. The company is optimistic about the ICoN-1 study and the potential benefits for patients with NTM. The drug has also received orphan drug and QIDP designations, potentially providing up to 12 years of market exclusivity.
MannKind (Nasdaq: MNKD) will host a conference call to discuss its 2024 first quarter financial results on May 8, 2024. Interested parties can listen live on the Company's website.
MannKind (Nasdaq: MNKD) has announced the initiation of a Phase 1 study for nintedanib DPI (MNKD-201) targeting pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). This study will assess safety, tolerability, and pharmacokinetics in healthy volunteers, with enrollment expected to commence in June 2024. The company aims to provide potential treatment options for patients with serious lung diseases, following their ongoing Phase 3 study of Clofazimine Inhalation Suspension for nontuberculous mycobacterial (NTM) lung diseases.
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