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) will have its CEO, Michael Castagna, PharmD, participating in a Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference on May 18, 2021, at 4:15 PM ET. This event will be accessible via a webcast from the Company’s website, with a replay available for 14 days post-event. MannKind specializes in inhaled therapeutic products for patients with endocrine and orphan lung diseases, notably commercializing Afrezza®, an FDA-approved ultra-rapid-acting inhaled insulin available by prescription in the U.S. and Brazil.
MannKind Corporation (MNKD) will release its first quarter 2021 financial results on May 12, 2021, at 5:00 PM Eastern Time. CEO Michael Castagna and CFO Steven B. Binder will lead the conference call to discuss these results and corporate updates. The company's inhaled therapeutic product, Afrezza, is the only FDA-approved inhaled ultra rapid-acting mealtime insulin available in the U.S. and Brazil, highlighting its significant market engagement.
MannKind Corporation (Nasdaq: MNKD) has made significant financial moves, including the repayment of a $35.1 million non-convertible note and a $10.0 million prepayment under its MidCap Credit Facility. These actions reduced annual interest expenses by approximately $5.0 million and increased available borrowings under Tranche 3 of the MidCap Credit Facility to $60.0 million. The company is also assessing a potential sale-leaseback of its manufacturing facility, aiming to enhance financial flexibility. CFO Steven B. Binder expressed confidence in the company’s cash position and manageable debt load.
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics have submitted a new drug application (NDA) to the FDA for Tyvaso DPI, a dry powder formulation of treprostinil. This marks a significant milestone as it follows MannKind's earlier product, Afrezza. The NDA submission could expedite the review process, with a potential FDA decision by December 2021. If approved, Tyvaso DPI aims to provide an innovative inhalation therapy for patients with pulmonary arterial hypertension (PAH) and associated conditions, impacting around 75,000 patients in the U.S.
MannKind Corporation (Nasdaq: MNKD) has announced the issuance of an additional $30 million in 2.50% Convertible Senior Notes due 2026, following the full exercise of the initial purchasers' option. This brings the total net proceeds from the offering to approximately $222.9 million. The notes will accrue interest at 2.50% annually, with a conversion rate of 191.8281 shares per $1,000 principal, translating to an initial conversion price of about $5.21 per share, a 30% premium over the stock's last reported sale of $4.01. The funds will be used for working capital and a Phase 3 clinical trial of Afrezza.
MannKind Corporation (Nasdaq: MNKD) announced its participation in the 2022 Medicare Part D Senior Savings Model to enhance insulin affordability for Medicare beneficiaries, capping monthly co-pays at $35 for its inhaled insulin, Afrezza®. With one-third of Medicare beneficiaries having diabetes, this initiative aims to alleviate cost barriers to treatment. MannKind's CEO, Michael Castagna, emphasized the importance of this model in improving healthcare access for seniors. The company recently launched AfrezzaAssist to further assist patients with affordability programs, including co-pay and cash purchase options.
MannKind Corporation (Nasdaq: MNKD) announced that its CEO, Michael Castagna, PharmD, will take part in a Fireside Chat at the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 1:50 PM (ET). Investors can access the webcast via the Events & Presentations section of MannKind's website, with a replay available for 14 days post-event. MannKind specializes in inhaled therapies for endocrine and orphan lung diseases, including the FDA-approved Afrezza inhalation powder, the only inhaled ultra rapid-acting mealtime insulin available in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the H.C. Wainwright Global Life Sciences Conference. The presentation will be available on demand starting March 9, 2021, at 7:00 am (ET). Interested viewers can access the webcast link from the Events & Presentations section of MannKind's website. The replay will be available for 14 days after the live event. MannKind focuses on inhaled therapeutic products, including the FDA-approved Afrezza®, an ultra-rapid-acting mealtime insulin available by prescription in the U.S. and Brazil.
MannKind Corporation (Nasdaq: MNKD) announced the pricing of $200 million of 2.50% Convertible Senior Notes due 2026. The offering to qualified institutional buyers is set to close on March 4, 2021. The notes will accrue interest at 2.50% per annum, payable semiannually. The initial conversion price is approximately $5.21 per share, a premium of 30% over the last sale price of $4.01. Net proceeds of approximately $193.8 million will fund working capital, including a Phase 3 clinical trial of Afrezza and other corporate purposes.
MannKind Corporation (NASDAQ: MNKD) announced a private placement offering of $150 million in Convertible Senior Notes due 2026. The offering may increase by an additional $22.5 million. Proceeds will support working capital, a Phase 3 clinical trial of Afrezza in pediatric patients, and development of other products. The notes are unsecured, and upon conversion, MannKind may pay in cash, stock, or both. The company does not currently plan to use proceeds for debt repayment or acquisitions. The securities will not be registered under the Securities Act.