MannKind Corp. (MNKD) stock prices were up by a marginal 0.64% as of the market closing on June 25th, 2021, bringing the price per share up to USD$4.74 at the end of the trading day. Subsequent premarket fluctuations saw the stock rise by 10.13%, bringing it up to USD$5.22.
FDA Acceptance of NDA
June 16th, 2021 announced the reaching of a major milestone with the U.S Food and Drug Administration accepting the company’s NDA for Tyvaso DPI. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstital lung disease (PH-ILD). Tyvaso is the second compound to be formulated with the company’s Technosphere technology to be reviewed by the FDA, with an expected completion date of October 2021.
Tyvaso DPI is a next-gen formulation of Treprostinil which incorporates the dry powder formulation technology and Dreamboat’s inhalation device. Both technologies are used in the company’s proprietary Afrezza Inhalation Powder, which was approved by the FDA in 2014. MNKD is collaborating with United Therapeutics are also collaborating to develop BluHale, which is a Bluetooth-connected accessory for the Tyvaso DPI inhaler. The accessory comes with an associated mobile application that is designed to help users track info about their inhaler use.
The collaborative duo entered into an exclusive global licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI. The FDA has indicated that approval of the submitted NDA will be contingent upon the results of an inspection of the Tyvaso DPI manufacturing facility. The inspection is forecasted to be conducted in the third quarter of 2021.
Tyvaso DPI NDA
The New Drug Application includes data from the BREEZE clinical study, which demonstrated the safety and tolerability of the treatment in PAH patients that were transitioning from Tyvaso Inhalation Solution. Another study in healthy volunteers was used to demonstrate comparable Treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution. The company is also entering into an expansion phase in preparation of building its pre-launch inventory of Tyvaso DPI. MNKD’s Danbury facility is scaling up by hiring more than 100 positions, as well as readying essential equipment and production lines.
Future Outlook for MNKD
Armed with an exciting new milestone in the development of Tyvaso DPI, MNKD is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of the treatment. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.