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MannKind Stock Slips Despite FDA Clearing Pediatric Use Of Heart Failure Drug — What’s Spooking Investors?
Sanjeev Kumar | December 24, 2025 4:21 AM CST

Shares fell as investors flagged limited commercial impact from the pediatric approval and questioned the timing of the announcement during thin holiday trading.

  • The FDA expanded Furoscix use to certain pediatric patients.
  • MannKind received five new U.S. patents supporting its ReadyFlow autoinjector, which is still under FDA review.
  • The FDA is expected to decide on the ReadyFlow application by July 26, 2026.

MannKind Corp (MNKD) shares fell on Tuesday even as the company announced regulatory and patent updates tied to its Furoscix drug, which is used to treat fluid buildup in people with heart failure and kidney disease.

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At the time of writing, the stock fell 1.4% to $5.91.

Furoscix Gets Pediatric Approval

The company said the U.S. Food and Drug Administration (FDA) approved wider use of Furoscix to include certain pediatric patients who weigh at least 43 kilograms. The drug was previously approved only for adults with fluid buildup caused by chronic heart failure or chronic kidney disease.

The company’s chief medical officer said the approval makes Furoscix available to a limited pediatric group and provides an option for treatment outside the hospital for patients who meet the weight requirement.

Patents Support ReadyFlow Autoinjector

MannKind also said it received five new U.S. patents related to its ReadyFlow autoinjector, a device under FDA review that is designed to deliver furosemide in seconds rather than hours.

The patents cover the drug formulation and methods of treatment and could provide protection through 2040 if the product is approved. The company said the patents would be listed in the FDA’s Orange Book upon approval.

ReadyFlow is based on technology developed by scPharmaceuticals, which MannKind acquired in August. Before the acquisition, scPharmaceuticals reported positive study results showing that the autoinjector delivered furosemide at levels comparable to intravenous dosing. In that study, patients had similar fluid removal results to IV treatment, reported little to no injection pain, and experienced side effects consistent with standard furosemide use.

The company reiterated that the FDA is reviewing its application for ReadyFlow for use in adults with heart failure or kidney disease, with a decision expected by July 26, 2026. 

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for MannKind was ‘bullish’ amid ‘high’ message volume.

MNKD sentiment and message volume as of December 23| Source: Stocktwits

One user said the pediatric approval carries limited commercial impact but signals regulatory comfort with Furoscix, which could be supportive ahead of the FDA’s July 2026 decision on the ReadyFlow autoinjector.

Another retail investor questioned the timing of the announcement, noting it was released just ahead of the Christmas holiday when market activity is typically thin.

MannKind’s stock has declined 0.9% so far in 2025.

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