MannKind shares rise 12.64% premarket after FDA approves updated Afrezza label with dosing guidance for insulin transition.

MannKind surged 12.64% in premarket trading following the U.S. Food and Drug Administration’s approval of an updated Afrezza label, which provides clearer starting dose guidance for patients transitioning from subcutaneous insulin regimens. The revised dosing recommendations, based on clinical trial data showing improved postprandial glucose outcomes, are expected to facilitate adoption by healthcare providers and enhance patient safety during therapy initiation. The update addresses a key limitation of prior labeling, reinforcing Afrezza’s position as a differentiated inhaled insulin option for adults with diabetes. The announcement aligns with MannKind’s strategy to improve clinical and commercial utility for its flagship product, directly supporting market confidence in its therapeutic value.