MannKind shares slide 22% as FDA delays review of Tyvaso DPI new drug application

Inhalable insulin specialist MannKind Corp. (NASDAQ:MNKD) announced that the FDA is extending its deadline to review United Therapeutics’ (NASDAQ:UTHR) new drug application (NDA) for Tyvaso DPI from February to May.

MannKind is developing Tyvaso DPI (treprostinil) in collaboration with United Therapeutics.

The drug candidate Tyvaso DPI would potentially treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

MNKD shares fell 22.54% to $2.84 in afternoon trading, while UTHR shares dipped 13.81% to $166.45.

FDA has asked for additional information about the pulmonary safety of Tyvaso DPI related to a pending citizen petition filed in July 2021. The petition questions the safety of fumaryl diketopiperazine (FDKP), an excipient used in Tyvasson DPI. The excipient is also used in MannKind’s inhalable insulin product Afrezza.

The petition requests that FDA require additional testing …

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MannKind enrolls first patient in Afrezza study focusing on children

Rapid-acting insulin specialist MannKind Corp. (NSDQ:MNKD) has enrolled the first pediatric patient in its INHALE-1 study evaluating its Afrezza (Technosphere Insulin) with basal insulin versus multiple daily injections of insulin. The study will enroll participants aged four to 17 with type 1 or type 2 diabetes.

Afrezza first won FDA approval in 2014, and MannKind initially partnered with Sanofi (NSDQ:SNY) to market the drug. Sanofi pulled out of the partnership in 2016.

The INHALE-1 is a 26-week open-label, randomized study with a 26-week extension.

The primary endpoint of the study will be the average HbA1c level after 26 weeks. Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events at the same interval.

Earlier this year, MannKind CEO Michael Castagna said that the company has focused on increasing the number of presentations and publications related to Afrezza to boost its sales.

MNKD shares, …

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