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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) has announced the acquisition of the V-Go insulin delivery device from Zealand Pharma A/S for $10 million, plus sales-based milestones. This acquisition aims to enhance MannKind's portfolio of innovative diabetes solutions, reinforcing its commitment to mealtime diabetes management. The deal is expected to close in May 2022, subject to certain conditions. The V-Go device, designed for ease of use, complements MannKind's existing product, Afrezza, positioning the company for potential growth in the diabetes market.
MannKind Corporation (Nasdaq: MNKD) announced its participation in upcoming healthcare conferences, featuring CEO Michael Castagna as a presenter. Key events include the 2022 RBC Capital Markets Global Healthcare Conference on May 17 at 11:00 am ET, and the H.C. Wainwright Global Investment Conference on May 24 at 1:30 pm ET. Live webcasts of the presentations can be accessed via the Company’s website, with replays available for 14 days post-event. MannKind focuses on inhaled therapeutic products, notably Afrezza®, the first FDA-approved inhaled mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) reported Q1 2022 financial results with Afrezza net revenue of $9.8 million, reflecting a 21% increase from Q1 2021. The company's gross profit rose 99% to $7.5 million, supported by a 77% gross margin. Total revenues were $12.0 million, impacted by a $7.2 million drop in collaborations and services revenue due to completed R&D services with United Therapeutics. Net loss grew to $26.0 million, or $0.10 per share, attributed to reduced collaboration revenue and increased costs. Cash reserves stood at $233.0 million as of March 31, 2022.
MannKind Corporation (Nasdaq: MNKD) will announce its Q1 2022 financial results on May 5, 2022, at 5:00 PM ET. The call will feature CEO Michael Castagna and CFO Steven Binder, discussing key financial updates and company developments. MannKind is known for its Afrezza inhaled insulin, the only ultra-rapid-acting mealtime insulin available in the U.S. and Brazil. Investors can access the live call via the company's website for comprehensive insights into performance and strategic direction during the session.
MannKind Corporation (Nasdaq: MNKD) announced a significant breakthrough in diabetes management at the ATTD 2022 conference. A proof-of-concept study revealed that a simplified 2x dose of Technosphere® Insulin (TI) resulted in a mean difference of 52 mg/dL in post-prandial glucose excursions (PPGE) at 120 minutes compared to the standard dosage, showing enhanced efficacy without new safety concerns. This approach may improve glycemic control for diabetes patients and could influence future dosing recommendations.
United Therapeutics announced positive results from the BREEZE study evaluating Tyvaso DPI in patients with pulmonary arterial hypertension (PAH). The study showed safety in transitioning from Tyvaso to Tyvaso DPI with no serious adverse events. Improvements in six-minute walk distance by 11.5 meters and patient satisfaction were reported. Long-term safety data from an optional extension phase indicated continued efficacy. FDA action on the New Drug Application for Tyvaso DPI is anticipated by
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will participate in the Lytham Partners Spring 2022 Investor Conference taking place virtually from April 4-7, 2022. The company's presentation will be available on April 4 at 11:00 am ET and can be accessed on their website, with an archived version for later viewing. Management will also be available for one-on-one meetings during the event. MannKind focuses on developing inhaled therapies, including the FDA-approved Afrezza® inhalation powder, which is the first ultra-rapid-acting mealtime insulin in the U.S.
MannKind Corporation (Nasdaq: MNKD) announced that Chief Scientific Officer Thomas Hofmann will participate in the Cantor Virtual Rare Orphan Disease Summit on March 29, 2022, at 8:00 AM PT. The company specializes in developing inhaled therapeutic products for endocrine and orphan lung diseases, notably Afrezza (insulin human) Inhalation Powder, the only FDA-approved inhaled ultra-rapid-acting mealtime insulin available in the U.S. by prescription.
MannKind Corporation (Nasdaq: MNKD) will participate in the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 4:00 pm (ET). CEO Michael Castagna will deliver a virtual presentation accessible via the company’s website. MannKind focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, notably commercializing Afrezza® (insulin human) Inhalation Powder, the only inhaled ultra-rapid-acting mealtime insulin in the U.S. The webcast will be available for 14 days post-event.
MannKind Corporation (Nasdaq: MNKD) reported total revenues of $75.4 million for 2021, marking a 16% increase from 2020. Fourth quarter net revenue from Afrezza reached $11.3 million, up 13% year-over-year. Cash and investments stood at $260.7 million as of December 31, 2021. However, the company faced challenges, including a net loss of $80.9 million for the year and a significant increase in SG&A and R&D expenses. The review deadline for Tyvaso DPI has been extended to May 2022, impacting future revenue potential.
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