MannKind Corporation (MNKD) Seeks FDA Pediatric Approval for Afrezza

We recently published 10 Best Biotech Stocks to Buy Under $10. MannKind Corporation stands fifth among them.

MannKind Corporation (NASDAQ:MNKD) is a biopharmaceutical company developing inhaled therapeutic products for endocrine and orphan lung diseases. Its flagship product, Afrezza, is a rapid-acting inhaled insulin, and the company’s pipeline includes therapies for rare lung conditions such as nontuberculous mycobacterial (NTM) lung disease and idiopathic pulmonary fibrosis (IPF).

MannKind Corporation (NASDAQ:MNKD) submitted a supplemental Biologics License Application (sBLA) to the FDA to expand Afrezza use to pediatric patients aged 4–17. This submission is supported by positive Phase 3 INHALE-1 trial data demonstrating safety and efficacy in children, with a regulatory decision expected in Q4 2025.

The business is advancing its orphan lung disease portfolio. MNKD-101, an inhaled clofazimine for NTM lung disease, is enrolling ahead of schedule in its global Phase 3 ICoN-1 trial, while MNKD-201, targeting IPF, is planned to enter Phase 2 trials by year-end.

The corporation secured up to $500 million in non-dilutive financing to support the pediatric Afrezza rollout, expand commercial capabilities, and accelerate clinical programs. The company is also exploring artificial intelligence to optimize product delivery systems, enhancing operational efficiency and patient outcomes.

The U.S.-based manufacturing facility in Danbury, Connecticut, supports both revenue generation and pipeline production, minimizing supply chain risks. MannKind Corporation (NASDAQ:MNKD)’s revenue is further strengthened by royalties from Tyvaso DPI, an inhaled therapy for pulmonary arterial hypertension developed in partnership with United Therapeutics.

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Disclosure: None.