At the last check today, MannKind Corporation (MNKD) had reached $4.48, good for an increase of 9.27% in premarket session. The MannKind stock price dropped -0.73% to $4.10 at the end of the last trading session. MNKD stock price ranged between $4.08 and $4.18. MNKD stock surged on approval of its drug by authorities.

In what way did the achievement succeed?

MannKind specializes in developing and commercializing inhaled therapeutic products for patients with endocrine and orphan lung diseases. Afrezza Inhalation Powder is currently being sold by MNKD. As the only mealtime insulin available in the United States that is inhaled and acts very quickly, Afrezza is MNKD’s first FDA-approved product. All pharmacies in the United States offer the drug on prescription.

The US Food and Drug Administration (FDA) today accepted the New Drug Application (NDA) for priority review submitted by MannKind and United Therapeutics Corporation (Nasdaq: UTHR). Tyvaso DPI (inhaled treprostinil) from MNKD has been given a priority review status for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung diseases (PH-ILD).

MNKD’s Technosphere technology is being used to formulate the second compound to be reviewed by the FDA, which should be completed in October 2021. Also, FDA officials have said they haven’t found any issues with the review process at the moment.

MNKD moving forward:

This important step will allow MannKind (MNKD) to produce the next Technosphere product more conveniently for thousands of PAH and PH-ILD patients. As of September 2018, MNKD and United Therapeutics have signed an exclusive licensing and collaboration agreement for Tyvaso DPI.

MNKD’s Tyvaso DPI manufacturing facility will be inspected by the FDA before the FDA approves the Tyvaso NDA. In the third quarter of 2021, FDA and MNKD plan to complete the inspections.