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 Corporation (Nasdaq: MNKD) announced a sale-leaseback transaction with Creative Manufacturing Properties, expected to generate $102.25 million in gross proceeds. This strategic move allows MannKind to unlock capital from its manufacturing facility, supporting growth and development initiatives.
The transaction involves a 20-year lease for a 263,900 sq. ft. manufacturing space in Danbury, where MannKind produces its FDA-approved product, Afrezza. The company plans to utilize the funds to enhance its product pipeline and expand Afrezza's commercial activities.
MannKind Corporation (Nasdaq: MNKD) announced its participation in the Lytham Partners Fall 2021 Investor Conference on October 5, 2021, at 11:45 am ET. CEO Michael Castagna, PharmD, will represent the company during the event. Interested parties can access a live webcast of the presentation through the Company’s website. MannKind focuses on developing inhaled therapeutic products, including Afrezza®, the only inhaled ultra rapid-acting insulin available in the U.S. The webcast replay will be available for 14 days post-event.
MannKind Corporation (Nasdaq: MNKD) announced its participation in two upcoming conferences, featuring CEO Michael Castagna, PharmD as a presenter. The events include the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021, and the 2021 Cantor Global Virtual Healthcare Conference on September 27, 2021. Interested individuals can access live webcasts and replays on the company’s website for 14 days post-event. MannKind is known for developing inhaled therapeutic products, including Afrezza, an FDA-approved inhaled insulin available in the U.S. and Brazil.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright 23rd Annual Global Investment Conference, available on demand from September 13, 2021. Interested parties can access the webcast through the Company’s Events & Presentations section on their website, where a replay will be available for 14 days. MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, including Afrezza®, the only inhaled ultra rapid-acting mealtime insulin in the U.S.
United Therapeutics Corporation (Nasdaq: UTHR) showcased the BREEZE study results for Tyvaso DPI™ at the European Respiratory Society Congress 2021. This next-generation inhalation solution for pulmonary arterial hypertension (PAH) demonstrated significant safety and tolerability, with 96% completion rate in a three-week trial. Key findings included an 11.5-meter increase in six-minute walk distance and enhanced patient satisfaction with the device. The FDA is expected to review Tyvaso DPI's NDA in October 2021, which could enhance therapeutic accessibility for PAH patients.
MannKind Corporation (MNKD) reported Q2 2021 revenues of $23.3 million, a 54% increase year-over-year, driven by Afrezza net revenue of $10.0 million. The company reported a net loss of $35.5 million, or $0.14 per share, compared to a net loss of $10.3 million in Q2 2020. Gross profit from Afrezza surged 68% to $5.6 million, enhancing gross margin to 56% (or 76% on a non-GAAP basis). Cash equivalents amounted to $201.4 million as of June 30, 2021, bolstered by $230 million in convertible notes issued earlier this year.
NRx Pharmaceuticals has partnered with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil) for respiratory conditions. Utilizing MannKind's Technosphere® platform, the collaboration aims to create an inhalable delivery system that enhances patient convenience. ZYESAMI™ has shown promising results in clinical trials for COVID-19 patients. NRx has received Fast Track Designation from the FDA and is conducting phase 3 trials for both intravenous and inhaled formulations, funded by the NIH and BARDA.
MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) to explore a dry powder formulation of ZYESAMI (aviptadil), aimed at treating respiratory failure due to COVID-19. Currently, ZYESAMI's intravenous formulation is in clinical trials with FDA Fast Track Designation. MannKind's CEO emphasized the potential of their Technosphere technology for delivering treatments effectively. The research is set to occur at MannKind's Danbury facility, which has significant production capabilities.
MannKind Corporation (Nasdaq:MNKD) will announce its Q2 2021 financial results on August 11, 2021, at 5 PM ET. The conference call will feature insights from CEO Michael Castagna and CFO Steven B. Binder. Investors can access the call and the subsequent replay on MannKind's website. MannKind focuses on inhaled therapeutic products, notably the FDA-approved Afrezza, the only inhaled ultra-rapid-acting insulin available in the U.S. and Brazil. The company was founded in 1991 and is based in Westlake Village, California.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference on August 10, 2021, at 12:30 PM (ET). This event is exclusive to BTIG clients. MannKind focuses on developing and marketing inhaled therapies for patients with endocrine and orphan lung diseases. Its leading product is Afrezza®, the only inhaled ultra-rapid-acting mealtime insulin available in the U.S. for prescription.
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