FDA Approves Key Prescribing Update for MannKind’s Inhaled Insulin

MannKind US56400P7069

The U.S. Food and Drug Administration (FDA) has approved a significant revision to the prescribing information for MannKind Corporation's inhaled insulin product, Afrezza. The update, confirmed on January 26, provides healthcare professionals with a formalized dose conversion chart for transitioning patients from injectable mealtime insulin to the inhaled therapy. This regulatory move is seen as a practical step to streamline clinical adoption.

The announcement coincided with a notable uptick in the company's share price, which advanced by 3.5% on the day of the approval. This development follows a recent positive business update from MannKind. On January 8, the firm confirmed that its net revenue for the fourth quarter of 2025 surpassed the $100 million threshold for the first time. This growth is attributed to several factors, including the acquisition of scPharmaceuticals, which added the Furoscix portfolio, alongside licensing and revenue shares from Tyvaso DPI.

Details of the New Dosing Guidance

Central to the FDA's label update is a clear conversion table designed to optimize post-meal blood glucose levels immediately after a patient switches therapies. According to the new guidelines:
* Patients previously injecting up to 3 units of mealtime insulin should initiate therapy with a 4-unit dose of the inhaled powder.
* For those injecting 8 units or more, the recommended starting inhaled dose is 16 units.

This structured approach is based on clinical evidence from the Dose Optimization study and the INHALE-3 trial, both of which demonstrated improved postprandial blood sugar control with Afrezza.

Upcoming Catalysts and Regulatory Timeline

Looking ahead, MannKind's operational and regulatory calendar for 2026 is populated with several key milestones that will be critical for investors to monitor:

• Q4 2025 Earnings: Full financial results are scheduled for release on February 25.
• Pediatric Afrezza Decision: The FDA has accepted a supplemental Biologics License Application for a pediatric indication of Afrezza, with a target action date of May 29. Company statements note that approval would mark the first needle-free insulin option for children in over a century.
• Furoscix Device Review: A Prescription Drug User Fee Act (PDUFA) date of July 26 is set for the Furoscix ReadyFlow Autoinjector.
• Pipeline Readout: Clinical development continues in the orphan lung disease pipeline. The first patient was enrolled in a Phase 1b study for nintedanib DPI in late 2025, with a readout from the TETON-1 trial expected in the first half of 2026.

In the near term, the updated prescribing information and the strong Q4 revenue provide tangible support for the company's commercial narrative. However, the forthcoming announcements on February 25, May 29, and July 26 are poised to be decisive for assessing MannKind's ongoing operational and regulatory progress.