Shares of MannKind (MNKD) climbed 20% Wednesday morning after the company revealed positive late-stage trial results for its experimental diabetes drug.
The Valencia, Calif.-based drug developer said two Phase III clinical studies for Afrezza, an ultra rapid-acting mealtime insulin therapy administered through MannKind’s next-generation inhaler, met their primary endpoints.
The results "will form the basis of an amendment to our new drug application for AFREZZA, which we expect to submit to the Food and Drug Administration early in the fourth quarter of this year,” MannKind CEO Alfred Mann said in a statement.
In patients with type 1 diabetes, the drug, compared with insulin aspart, showed significantly less hypoglycemia, significant decreases in fasting blood glucose levels and significant weight advantage.
For those with type 2, Afrezza showed superior reduction in A1c levels, allowing “significantly more patients” to reach A1c target levels, as well as reduced postprandial glucose excursions.
The results are preliminary and subject to further analysis.
Shares of MannKind climbed about 20% in early trade after reaching a 52-week intraday high of $8.70 earlier in the session.