MannKind gains on Afrezza data

MannKind Corp. (NASDAQ:MNKD) gained $0.66 (12%) to $6.25 on Thursday after the company said Afrezza plus Lantus insulin glargine was non-inferior to Humalog insulin lispro plus Lantus on the primary endpoint of reducing mean HbA1c from baseline to week 16 in a Phase III trial to treat Type I diabetes (0.1% vs. 0.03%). Afrezza is a dry powder formulation of insulin plus an inhaler. The open-label trial enrolled 130 patients with inadequately controlled Type I diabetes.

In March, FDA issued a complete response letter for an NDA for Afrezza requesting currently available data to support clinical utility of Afrezza. MannKind said it is preparing to resubmit the NDA (See BioCentury Extra, Monday, March 15, 2010). ...