How 2026 FDA Decisions on Afrezza and FUROSCIX At MannKind (MNKD) Have Changed Its Investment Story

Simply Wall St.

Jan 10

MannKind Corporation recently released a business update outlining past progress and key upcoming regulatory milestones, including anticipated 2026 FDA decisions on an Afrezza label update, a ...

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A particularly important development is the alignment of multiple regulatory review timelines across Afrezza and FUROSCIX with ongoing pipeline work on inhaled nintedanib and bumetanide, which together could materially influence how investors assess MannKind’s product mix and long-term revenue profile. With the FDA’s upcoming Afrezza label decision now in focus, we’ll assess how this catalyst may reshape MannKind’s existing investment narrative. We've found 12 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.AdvertisementMannKind Investment Narrative RecapTo own MannKind, you have to believe in its ability to build a broader inhaled-therapy franchise around Afrezza and FUROSCIX while managing concentrated product risk and high investment needs. The latest business update reinforces that the key near term catalyst remains the FDA decision on the Afrezza label in January 2026, while regulatory timing alignment across Afrezza and FUROSCIX does not materially change the central risk around adoption and payer support for the core portfolio. Within the new disclosures, the FDA’s acceptance of the supplemental NDA for the FUROSCIX ReadyFlow Autoinjector stands out, because its July 26, 2026 PDUFA date now sits alongside Afrezza’s adult label and pediatric reviews as a cluster of potential inflection points. Taken together, these overlapping decisions could meaningfully influence how much of MannKind’s future still rests on a relatively narrow set of commercial assets versus a more diversified inhaled platform. However, against these upcoming decisions, investors should be aware that MannKind’s reliance on a limited core portfolio could... Read the full narrative on MannKind (it's free!)MannKind's narrative projects $437.5 million revenue and $70.4 million earnings by 2028. This requires 13.2% yearly revenue growth and a $37.6 million earnings increase from $32.8 million today.Uncover how MannKind's forecasts yield a $9.61 fair value, a 64% upside to its current price.Exploring Other PerspectivesMNKD 1-Year Stock Price Chart Four members of the Simply Wall St Community currently place MannKind’s fair value between US$7.42 and US$23.05, highlighting a wide spread of individual assumptions. Set against that, the concentration of revenue in Afrezza and Tyvaso DPI royalties means any regulatory or competitive setback could have an outsized effect, so it pays to compare several viewpoints before forming a view on the stock.Explore 4 other fair value estimates on MannKind - why the stock might be worth just $7.42!Build Your Own MannKind NarrativeDisagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.A great starting point for your MannKind research is our analysis highlighting 4 key rewards and 3 important warning signs that could impact your investment decision.Our free MannKind research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate MannKind's overall financial health at a glance.No Opportunity In MannKind?Our top stock finds are flying under the radar-for now. Get in early:Trump has pledged to \"unleash\" American oil and gas and these 22 US stocks have developments that are poised to benefit.Uncover the next big thing with financially sound penny stocks that balance risk and reward.The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 28 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement.  This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    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\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: Manage All Your Stock Portfolios in One PlaceWe've created the ultimate portfolio companion for stock investors, and it's free.• Connect an unlimited number of Portfolios and see your total in one currency• Be alerted to new Warning Signs or Risks via email or mobile• Track the Fair Value of your stocksTry a Demo Portfolio for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. 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