Why MannKind (MNKD) Is Up 6.2% After FDA Accepts FUROSCIX ReadyFlow Autoinjector sNDA Filing

• MannKind Corporation recently announced that the FDA has accepted its supplemental New Drug Application for the FUROSCIX ReadyFlow Autoinjector, an under-10-second subcutaneous furosemide delivery option for adults with edema due to chronic heart failure or chronic kidney disease, with a PDUFA target action date of July 26, 2026.
• Backed by bioequivalence data showing comparable diuretic effects to IV furosemide, ReadyFlow could meaningfully upgrade at-home management versus the current five-hour FUROSCIX on-body infusor.
• We’ll now examine how the potential shift to ultra-rapid, at-home diuretic delivery with ReadyFlow might influence MannKind’s investment narrative.

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MannKind Investment Narrative Recap

To own MannKind, you have to believe it can turn a focused portfolio in inhaled and specialty therapies into durable, diversified cash flows while managing high investment needs and competition. The ReadyFlow sNDA acceptance is encouraging, but it does not change that Afrezza adoption and concentration in a few key products remain the most important near term drivers and risks for the story.

The ReadyFlow news sits alongside MannKind’s recent string of profitable quarters, including Q3 2025 revenue of US$82.13 million and net income of US$7.99 million, which highlight the company’s progress in scaling its existing portfolio. How well MannKind can leverage FUROSCIX, Afrezza and its partnership with United Therapeutics into broader uptake now becomes the key question for investors watching upcoming catalysts.

However, against this backdrop of new products and growing revenue, MannKind’s dependence on a small set of core assets is a risk investors should be aware of, because...

Read the full narrative on MannKind (it's free!)

MannKind's narrative projects $437.5 million revenue and $70.4 million earnings by 2028.

Uncover how MannKind's forecasts yield a $9.39 fair value, a 65% upside to its current price.

Exploring Other Perspectives

Four Simply Wall St Community fair value estimates for MannKind currently range from US$7.42 to about US$18.27, showing how far apart individual views can be. You may want to weigh these against the concentration risk in Afrezza and Tyvaso DPI royalties, which could influence how the company handles any future product setbacks or slower than expected uptake.

Explore 4 other fair value estimates on MannKind - why the stock might be worth over 3x more than the current price!

Build Your Own MannKind Narrative

Disagree 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 3 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.

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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.

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