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MNKD News
MNKD Events
MannKind Announces Positive Results from INFLO-1 Study
MannKind announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation in patients with idiopathic pulmonary fibrosis. The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days. Key findings from the study included: No serious adverse events; No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting); No bronchospasm events; No treatment discontinuations or dose reductions; No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges); Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved. Additional data will be presented at a future conference.
MannKind Completes $50M Private Placement Financing
MannKind announced that it has entered into a securities purchase agreement in connection with a private placement to certain institutional investors. The gross proceeds from the private placement financing are expected to be approximately $50M. The closing of the financing is expected to occur on or about July 24, subject to the satisfaction of customary closing conditions.The private placement was led by Frazier Life Sciences, a longstanding biotech investment firm. Pursuant to the terms of the securities purchase agreement, MannKind is selling an aggregate of 10,440,838 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,412,632 shares of its common stock, at a purchase price of $3.89 per share and $3.88 per pre-funded warrant. The pre-funded warrants will have an exercise price of $0.01 per share and will be exercisable at any time after original issuance, subject to certain beneficial ownership limitations, and will not expire until exercised in full.
MannKind Receives FDA Approval for Furoscix ReadyFlow to Treat Edema
MannKind announced that the U.S. FDA has approved Furoscix ReadyFlow for the treatment of edema in adults with heart failure or chronic kidney disease. Furoscix ReadyFlow is an at-home treatment option designed to help adults with heart failure or chronic kidney disease address fluid overload earlier, before worsening symptoms may lead to emergency department visits, hospitalization, or readmission.
MannKind Achieves Key Clinical Milestones for Nintedanib DPI
MannKind announced key clinical execution milestones in the development of nintedanib DPI for idiopathic pulmonary fibrosis, or IPF, including the completion of patient randomization in the U.S. Phase 1b INFLO-1 clinical trial and enrollment of the first patient in the global Phase 2 INFLO-2 study. These milestones mark the advancement of the nintedanib DPI program and support its progression into mid-stage clinical evaluation. MannKind expects to report data from the INFLO-1 study in the Q3, which is expected to provide an initial clinical assessment of safety, tolerability, and pharmacokinetics in patients with IPF. INFLO-2 is expected to enroll approximately 210 participants across approximately 85 sites worldwide. The first patient was enrolled in Windsor, Canada. IPF is a chronic, progressive lung disease characterized by irreversible fibrosis and declining lung function. Despite available therapies, the disease remains associated with substantial morbidity and mortality. Nintedanib, currently approved as an oral therapy for IPF, has demonstrated the ability to slow disease progression but can be associated with systemic side effects that may limit tolerability, treatment persistence, and the ability to use combination therapies. Nintedanib DPI leverages MannKind's Technosphere dry powder inhalation technology to deliver nintedanib directly to the deep lung, with the goal of achieving therapeutic concentrations at the site of disease while reducing systemic exposure. MannKind has developed two FDA-approved dry powder inhalation therapies utilizing its proven Technosphere formulation technology, with clinical data demonstrating less than 3% discontinuation due to cough. A randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of nintedanib DPI in patients with IPF followed by an open-label extension. The global study will randomize participants in a 1:1:1 ratio to receive either nintedanib DPI or placebo for 12 weeks, followed by a 24-week open-label extension in which all participants may receive active treatment. The primary objective of the study is to assess safety and tolerability and to determine an optimal dose of nintedanib DPI. INFLO-1 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib DPI in patients with IPF. The U.S. trial consists of multiple ascending doses with the primary objective to evaluate safety, tolerability and pharmacokinetics of nintedanib DPI compared to placebo in patients with IPF.
MannKind Receives FDA Approval for Afrezza in Children Aged 6 and Up
MannKind announced that the U.S. Food and Drug Administration has approved Afrezza Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. This approval expands Afrezza's availability beyond adults, introducing a new mealtime insulin option for pediatric patients and caregivers. The FDA approval is supported by results from the pivotal INHALE-1 clinical trial, along with additional safety, efficacy, and long-term exposure data from studies evaluating inhaled insulin over the past two decades of development.
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