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MannKind Corporation (Nasdaq: MNKD) is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative inhaled therapeutic products for patients with serious unmet medical needs. The company focuses on treating diseases such as diabetes, pulmonary arterial hypertension, and nontuberculous mycobacterial (NTM) lung disease.
Their flagship product, Afrezza, is an ultra-rapid-acting inhaled insulin designed to improve glycemic control in adults with diabetes. This product features a dry powder formulation of human insulin delivered via a small, portable inhaler.
MannKind's latest advancements include the initiation of a Phase 3 trial for Clofazimine Inhalation Suspension aimed at treating refractory NTM lung disease. The trial, named ICoN-1, will evaluate the efficacy and safety of the drug when added to standard therapy. This initiative is a response to the increasing global prevalence of NTM lung infections, which pose significant health risks and complications for patients.
Additionally, MannKind is progressing with a Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). This study will assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers.
The company's technological prowess is underlined by its proprietary Technosphere® dry-powder technology, which facilitates rapid and effective delivery of medicines to the deep lung. This technology, combined with their inhalation devices, is used to develop new treatments that can either act locally in the lungs or enter the systemic circulation, depending on the medical need.
In a strategic partnership, MannKind has in-licensed Pulmatrix's iSPERSE™ technology to enhance their formulation capabilities. This collaboration also includes exchanging MannKind's Cricket® inhaler technology to aid in the development of inhaled treatments for migraine and other neurological diseases.
Financially, MannKind continues to invest in R&D to expand its product pipeline and enhance its technological platforms. The company’s partnerships, such as the recent agreement with Pulmatrix, are also set to strengthen MannKind's market position in the biopharmaceutical landscape.
With a dedicated team and a robust pipeline, MannKind Corporation remains at the forefront of developing effective inhaled therapies, striving to improve patient outcomes and quality of life.
MannKind Corporation (Nasdaq: MNKD) announced a poster presentation at the ATTD 2021 conference showcasing a post hoc analysis from the STAT study. This analysis revealed that Afrezza (Technosphere Insulin) significantly reduced nocturnal hypoglycemia in adults with type 1 diabetes, showing a 62% reduction in Level 1 and a 78% reduction in Level 2 hypoglycemia compared to insulin aspart. The study included 60 patients over four weeks and highlighted Afrezza's ultra-rapid action as a potential benefit. Larger studies are needed to validate these results.
MannKind Corporation (Nasdaq: MNKD) partners with IndyCar driver Conor Daly, who is living with Type 1 diabetes (T1D), to engage local youth in a karting event. Scheduled for May 25, 2021, in Indianapolis, Daly will share his diabetes journey and offer karting tips. As the only professional U.S. racer with T1D, Daly aims to inspire others by proving that diabetes does not limit potential. The event will include a go-kart race to identify the fastest racers among the youth participants.
MannKind Corporation (Nasdaq: MNKD) announced a partnership with NTT INDYCAR SERIES driver Conor Daly, who is living with Type 1 diabetes, as part of its 2021 season sponsorship. Daly will debut the No. 20 MannKind Chevrolet at the GMR Grand Prix on May 15 at Indianapolis Motor Speedway. The car features a distinctive 'Tired of Pricks?' tagline, promoting innovative diabetes management. MannKind aims to raise awareness of diabetes, emphasizing that living with the condition shouldn't hinder pursuing dreams. This partnership underscores MannKind's commitment to finding new health management options.
MannKind Corporation (NASDAQ:MNKD) reported a 7% revenue increase to $17.4 million for Q1 2021, driven by Afrezza’s net revenue of $8.1 million and collaboration services revenue of $9.3 million. The company raised $230 million through senior convertible notes, significantly enhancing its financial position, with cash and equivalents at $278.3 million. While gross profit remained steady at $3.8 million, R&D and SG&A expenses rose by 39% and 21%, respectively. The net loss increased to $12.9 million, or $0.05 per share, partly due to higher interest expenses.
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.
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