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MannKind's Supplemental BLA for Diabetes Treatment Afrezza Facing 'Limited Regulatory Risk,' Wedbush Says
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MannKind's Supplemental BLA for Diabetes Treatment Afrezza Facing 'Limited Regulatory Risk,' Wedbush Says
Oct 13, 2025 9:40 AM

12:29 PM EDT, 10/13/2025 (MT Newswires) -- MannKind's ( MNKD ) supplemental biologics license application for Afrezza to treat children and adolescents with type 1 or type 2 diabetes is facing "limited regulatory risk" as the company aims for an approval that would expand the drug's addressable market by another 300,000 patients, Wedbush said in a Monday note.

Wedbush said that low awareness among both patients and physicians has been the main reason for the lack of adoption of Afrezza so far and that MannKind ( MNKD ) was addressing the issue with promotion efforts.

Additional development for Afrezza could further increase its commercial potential, Wedbush said, adding that two studies appear to be planned, one in treatment naive pediatric patients and other to evaluate the use of Afrezza in highly active patient population.

Wedbush maintained its outperform rating with a $11 price target.

Price: 5.06, Change: +0.17, Percent Change: +3.48

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