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 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.
MannKind Corporation (Nasdaq: MNKD) announced that the FDA issued an information request to United Therapeutics regarding the New Drug Application for Tyvaso DPI. This request pertains to additional information on the pulmonary safety of the product, linked to a Citizen Petition. The FDA now considers the response a major amendment, extending the review deadline to May 2022. MannKind will discuss its 2021 financial results and updates in a conference call on February 24, 2022. Tyvaso DPI remains investigational and is not approved for any use.
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