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MannKind Company (MNKD) Seeks FDA Pediatric Approval for Afrezza

Madisony
Last updated: August 30, 2025 10:27 am
Madisony
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MannKind Company (MNKD) Seeks FDA Pediatric Approval for Afrezza
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We lately revealed 10 Finest Biotech Shares to Purchase Beneath $10. MannKind Company stands fifth amongst them.

MannKind Company (NASDAQ:MNKD) is a biopharmaceutical firm growing inhaled therapeutic merchandise for endocrine and orphan lung ailments. Its flagship product, Afrezza, is a rapid-acting inhaled insulin, and the corporate’s pipeline consists of therapies for uncommon lung situations corresponding to nontuberculous mycobacterial (NTM) lung illness and idiopathic pulmonary fibrosis (IPF).

MannKind Company (NASDAQ:MNKD) submitted a supplemental Biologics License Utility (sBLA) to the FDA to develop Afrezza use to pediatric sufferers aged 4–17. This submission is supported by optimistic Part 3 INHALE-1 trial information demonstrating security and efficacy in kids, with a regulatory resolution anticipated in This autumn 2025.

The enterprise is advancing its orphan lung illness portfolio. MNKD-101, an inhaled clofazimine for NTM lung illness, is enrolling forward of schedule in its international Part 3 ICoN-1 trial, whereas MNKD-201, focusing on IPF, is deliberate to enter Part 2 trials by year-end.

The company secured as much as $500 million in non-dilutive financing to help the pediatric Afrezza rollout, develop industrial capabilities, and speed up scientific applications. The corporate can be exploring synthetic intelligence to optimize product supply techniques, enhancing operational effectivity and affected person outcomes.

MannKind Company (MNKD) Seeks FDA Pediatric Approval for Afrezza

A scientist in a white lab coat measuring liquid in a beaker within the biotechnology lab.

The U.S.-based manufacturing facility in Danbury, Connecticut, helps each income era and pipeline manufacturing, minimizing provide chain dangers. MannKind Company (NASDAQ:MNKD)’s income is additional strengthened by royalties from Tyvaso DPI, an inhaled remedy for pulmonary arterial hypertension developed in partnership with United Therapeutics.

Whereas we acknowledge the potential of MNKD as an funding, we consider sure AI shares supply larger upside potential and carry much less draw back threat. In the event you’re in search of an especially undervalued AI inventory that additionally stands to learn considerably from Trump-era tariffs and the onshoring development, see our free report on the greatest short-term AI inventory.

READ NEXT: The Finest and Worst Dow Shares for the Subsequent 12 Months and 10 Unstoppable Shares That May Double Your Cash.

Disclosure: None.

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