Earlier in January, MannKind Corporation outlined upcoming 2026 regulatory milestones, including FDA decisions on Afrezza label updates, a pediatric Afrezza sBLA, and the FUROSCIX ReadyFlow Autoinjector sNDA.
These potential approvals could broaden Afrezza’s use into pediatrics while adding a new needle-free diuretic delivery option, sharpening MannKind’s focus on inhaled and device-enabled therapies.
We’ll now examine how the anticipated pediatric Afrezza decision, alongside other regulatory milestones, shapes MannKind’s evolving investment narrative.
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To own MannKind today, you have to believe in its inhaled and device-enabled drug delivery platform as more than a single-product story, while accepting meaningful execution and balance sheet risk. The latest 2026 regulatory update sharpens that thesis: potential Afrezza label simplification, a pediatric sBLA decision, and the FUROSCIX ReadyFlow Autoinjector sNDA now sit at the center of the short term catalyst stack. If outcomes are favorable, they could deepen Afrezza’s reach into pediatrics and extend FUROSCIX beyond the current on-body infusor, which may strengthen MannKind’s emerging profitability trend and help justify a premium P/E multiple. If they disappoint, the valuation, already rich against peers, could come under pressure, especially with high debt and negative equity still on the table.
However, one risk in particular could quickly change how investors view all of this. MannKind’s shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.
MNKD 1-Year Stock Price Chart
Four Simply Wall St Community fair value estimates for MannKind span roughly US$7.42 to US$22.67, underlining how far apart private investors can be. Against that backdrop, the 2026 FDA decisions around Afrezza and FUROSCIX that now anchor the story may end up being just as important to sentiment as to MannKind’s operating performance, so it is worth weighing several viewpoints before forming a view.
Explore 4 other fair value estimates on MannKind – why the stock might be worth over 3x more than the current price!
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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include MNKD.
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