MannKind (MNKD) Is Down 9.9% After FDA Reviews Afrezza for Pediatric Use Will Growth Prospects Shift?

• MannKind Corporation recently announced that the U.S. FDA has accepted its supplemental biologics license application for Afrezza inhaled insulin in children and adolescents, with the submission based on the results of the Phase 3 INHALE-1 study and a PDUFA target action date set for May 29, 2026.
• This regulatory milestone could position Afrezza as the first needle-free insulin option for pediatric diabetes patients, addressing a long-standing unmet need in pediatric care.
• We'll examine how potential FDA approval for pediatric use of Afrezza could shape MannKind’s future growth opportunities and risk profile.

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MannKind Investment Narrative Recap

To own MannKind shares, you must believe in the company's ability to broaden Afrezza's market reach and drive adoption, especially among pediatric patients who may benefit most from needle-free insulin. The FDA’s acceptance of the Afrezza pediatric application is now the key near-term catalyst, but this does not fully address the core risk of lagging adult prescription growth, which continues to limit revenue momentum and profitability efforts.

The most relevant recent development is MannKind’s June 2025 presentation at the American Diabetes Association, where results highlighted Afrezza's potential for pediatric care. Those early signals help set the stage for the current regulatory milestone, yet persistent challenges with broader prescriber adoption remain the primary risk as the pediatric review process unfolds.

However, investors should be aware that while growing the pediatric opportunity is promising, the dependence on niche adult usage means that...

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

MannKind's narrative projects $437.5 million in revenue and $70.4 million in earnings by 2028. This requires 13.2% yearly revenue growth and a $37.6 million increase in earnings from the current $32.8 million.

Uncover how MannKind's forecasts yield a $10.57 fair value, a 107% upside to its current price.

Exploring Other Perspectives

Four recent fair value estimates from the Simply Wall St Community range from US$7.42 up to US$27.52 per share. With current progress on pediatric Afrezza, the real challenge remains broad market adoption and prescriber engagement, consider how different viewpoints inform your outlook on MannKind’s future.

Explore 4 other fair value estimates on MannKind - why the stock might be worth over 5x 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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