MannKind (MNKD) Stock Heads Up On NDA Acceptance

MannKind Corporation (NASDAQ: MNKD) is headed up in the premarket hours this morning, and for good reason. The company announced that the FDA has accepted a New Drug Application for priority review. Here’s what’s happening:

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MNKD Heads Up On Priority Review Acceptance

MannKind and United Therapeutics have been working on a product known as Tyvaso DPI for some time now. The treatment is designed as a potential option for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. 

In the release issued this morning, MNKD and United said that the FDA has accepted the NDA for the drug for priority review. 

That’s a major milestone for the company. Not only is a new drug going to be reviewed by the regulatory agency, if approved, it will be the second compound formulated using the company’s Technosphere delivery system. 

Tyvaso DPI is a dry powder formulation using the Dreamboat inhalation device, the same device and delivery system featured in MannKind’s Afrezza. The two companies are also in the process of developing BluHale, a Bluetooth-connected accessory for the inhaler with a companion mobile application intended to help patients track their inhaler use. 

The news is the result of a worldwide exclusive licensing deal between MannKind and United Therapeutics that started in 2018. The New Drug Application includes data from the BREEZE clinical study, which demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso Inhalation Solution. 

In another study, healthy volunteers demonstrated comparable treprostinil exposure between the two products. 

Management Commentary

In a statement, Michael Castagna, PharmD CEO at MNKD, had the following to offer:

We are energized by the acceptance of the Tyvaso DPI NDA for priority review. MannKind is driven to deliver therapeutics in ways that can help improve patient lives for the better. With this key regulatory step, we are excited to progress the next Technosphere product towards providing thousands of PAH and PH-ILD patients a more convenient method of treprostinil therapy administration.

The above statement was followed up by Joe Kocinsky, MS, MBA, Chief Technology Officer at MNKD. Here’s what he had to say:

It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere® technology. Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.

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The Bottom Line

The bottom line here is simple, and it’s a message I haven’t strayed from for years. MannKind’s technosphere technology is a game changer that has the ability to change the way we see the delivery of medication for various ailments. Should Tyvaso DPI be approved, it will not only generate significant revenues for both companies involved, it will serve as yet another source of validation of the tremendous work done by the late Alfred Mann, work that continues to hold value, even after his death. All in all, Mann created both a meaningful legacy and a tremendous opportunity for MNKD investors!

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