Why Did MNKD Stock Jump Over 7% In Pre-Market Today?

• The revised label provides clearer starting-dose guidance for adult patients switching from multiple daily injections or insulin pump therapy.
• The update is supported by clinical results from the Dose Optimization study and the INHALE-3 trial.
• Previously, MannKind filed a supplemental FDA application to expand Afrezza’s use to patients aged four to 17, with a decision anticipated by May 29, 2026.

Shares of MannKind Corp. (MNKD) gained more than 7% in pre-market trading on Monday after the company announced that the U.S. Food and Drug Administration (FDA) approved an update to the prescribing information for Afrezza, its inhaled mealtime insulin used to improve glycemic control in adult patients with diabetes mellitus.

The revised label provides clearer starting-dose guidance for adult patients switching from multiple daily injections or insulin pump therapy. The update is supported by clinical results from the Dose Optimization study and the INHALE-3 trial, which showed significantly improved post-meal glucose control after conversion to Afrezza, as recommended by the new dosing recommendations.

“We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps. We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza’s established clinical profile,” said Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation. 

Q3 Revenue Boosted By Afrezza Sales

In November, the company posted a 17% increase in third-quarter (Q3) total revenue to $82.13 million, driven by strong growth in sales of its Afrezza inhaled insulin. Afrezza revenue climbed 23% to $18.5 million, supported by higher pricing and rising demand, while royalty income rose to $33.3 million.

MannKind also submitted a supplemental application to the FDA seeking approval of Afrezza for patients aged four to 17. A regulatory decision is expected by May 29, 2026.

How Did Retail React?

Retail sentiment for MNKD on Stocktwits remained in the ‘bullish’ zone over the past 24 hours, accompanied by ‘high’ message volumes. MNKD was among the top trending tickers at the time of writing.

Meanwhile, one user didn’t see the FDA update as a major catalyst.

The stock has declined around 4.7% year-to-date and over 10.5% in the past year.

Read also: AG, ASM, HL Stocks Soar Pre-Market As Silver Blasts Past $110

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