MannKind Enrolls First Patient in Pediatric Afrezza Trial, FDA Decision Expected May 2026

MannKind Corporation has enrolled the first pediatric patient in its INHALE-1ST clinical study, evaluating the safety and efficacy of Afrezza (insulin human) Inhalation Powder initiated soon after type 1 diabetes diagnosis in youth aged 10 and above, used alongside once-daily basal insulin. The FDA is currently reviewing a supplemental Biologics License Application for Afrezza inhaled insulin in children and adolescents, with a decision expected by May 29, 2026.

If the pediatric Afrezza label expansion is approved, it could introduce the first needle-free insulin option for young patients in more than a century. The FDA accepted the supplemental Biologics License Application in October 2025, positioning the inhaled insulin as a potential first needle-free insulin option for children in more than 100 years of insulin therapy, pending regulatory review.

MannKind focuses on inhaled therapeutics, and Afrezza is its inhaled insulin product for people with diabetes. Expanding into pediatric use would touch a large and highly engaged patient population, where treatment burden, comfort, and adherence are all key issues for families and care teams.

In January 2026, the FDA approved an update to Afrezza's adult prescribing information. Clearer dosing conversions and label language based on Dose Optimization and INHALE-3 data may make it easier for physicians to start adults on Afrezza. If adult adoption improves from a simpler label while pediatric use potentially opens up, Afrezza may gain more clinical visibility, though this will still need to contend with MannKind's high spending and dependence on Afrezza and Tyvaso DPI royalties.

At $5.66 versus a consensus target of $9.61, MannKind trades roughly 41% below where analysts currently sit. One valuation model flags MannKind as undervalued, trading about 76.2% below its estimated fair value. The 30 day return of 8.64% suggests recent positive sentiment ahead of the pediatric Afrezza readouts.

Consensus expects MannKind's earnings to climb, with narrative projections of $437.5 million revenue and $70.4 million earnings by 2028. The most pessimistic analysts saw only about $412.9 million of revenue and $44.3 million of earnings by 2028 and worry that slow Afrezza adoption and dependence on a few products could still weigh on the stock.

Key risks include three flagged concerns, including negative shareholders' equity and debt levels. The risk that Afrezza remains a niche option, particularly if pediatric uptake stalls or payers resist broader coverage, remains a consideration for investors. The FDA review and new INHALE-1ST trial could reshape expectations for Afrezza by clarifying how big the pediatric segment might be.