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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) announces the FDA's acceptance of the NDA for Tyvaso DPI™, intended for pulmonary arterial hypertension treatment. The priority review is expected to complete by October 2021, with no identified review issues so far. This advancement follows the company's collaboration with United Therapeutics to develop Tyvaso DPI, using MannKind’s Technosphere® technology. Additionally, MannKind is expanding its manufacturing facility in Connecticut, planning to hire over 100 employees to support the pre-launch inventory of Tyvaso DPI.
United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™ to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is expected to conclude by October 2021, with no identified review issues so far. Tyvaso DPI is a next-generation dry powder formulation, promising improved administration methods compared to traditional nebulization. The NDA includes data from the BREEZE study, which demonstrated the safety and tolerability of Tyvaso DPI.
MannKind Corporation (Nasdaq: MNKD) has partnered with Thirona Bio, Inc. for the development of FBM5712, a small molecule inhibitor targeting TGF-β for pulmonary fibrosis treatment. MannKind will conduct formulation and preclinical studies on this compound, which has potential applications for various fibrotic diseases. As part of the agreement, MannKind purchased a convertible note to support Thirona's financing. This collaboration aligns with MannKind's goal of launching new products annually from 2025 to 2030, amplifying its pipeline in pulmonary and dermatological conditions.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the Lytham Partners Summer 2021 Investor Conference on June 14, 2021, at 11:45 AM (ET). Attendees can access the webcast link on the Company's website, where a replay will be available for 14 days post-presentation. MannKind specializes in developing inhaled therapeutic products, including its FDA-approved product, Afrezza®, an inhaled ultra-rapid-acting mealtime insulin, available in the U.S. and Brazil.
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.