MannKind MNKD Stock News

MannKind Corporation (NASDAQ: MNKD) is headed up in the market this morning, trading on gains of more than 8%. However, I believe that once the reason for the gains really hits the mainstream, we’re going to see quite a bit more movement.

If you do some digging, you’ll see that the company hasn’t issued any press releases or SEC filings. In fact, the company hasn’t released anything, but it’s partner, United Therapeutics (NASDAQ: UTHR), has. Here’s what’s happening:

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UTHR News Sends MNKD Stock Up

In a press release issued this morning, United Therapeutics Corporation said that the FDA has accepted the New Drug Application for Trevyent for review. It is hoped that the drug will be approved by the FDA for the treatment of pulmonary arterial hypertension (PAH). So, what does this have to do with MannKind?

A while ago, MNKD and UTHR announced an agreement. Under the terms of the agreement, United Therapeutics would test the company’s Technosphere technology to create an inhalable powder version of Trevyent.

Importantly, the clinical trial, assessing the inhalable version of Trevyent was expected to begin in August of this year, according to ClinicalTrials.gov. While we haven’t heard any news associated with the trial initiation, this is likely around the corner.

Considering the fact that the FDA has accepted the NDA for Trevyent, UTHR is well on its way to earning an approval. Should the drug be approved, for the inhaled version of it to receive approval, MNKD and UTHR will only need to show that the drug is safely and effectively deliverable through this vehicle, setting the stage for MannKind to earn milestone and royalty payments associated with it.

Investors Haven’t Caught Up To The News

Because MannKind had nothing to do with the news issued today, it seems as though investors haven’t quite caught up. Those searching are finding little to nothing as a reason for the gains.

Nonetheless, when the masses see that a NDA was acceped by the FDA surrounding a drug that MNKD and UTHR are working on together. Should an approval take place, the opportunity here is going to be massive. So, keep an eye and try to beat the masses to the jump.

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2 COMMENTS

  1. The announcement today only represents a small step forward for Mannkind. Firstly FDA acceptance of an NDA for the pump delivered version of Trevyent does not mean it is approved. It just means the FDA believes it has the information it needs to make its review. Secondly approval of the parenteral version of the drug (delivered subcutaneously using a pump) does not guarantee approval of the inhaled version as there are differences in delivery performance that might affect safety and efficacy of the drug. This does not mean there are good prospects for the inhaled drug and hence for MannKind, just the journey to approval is far from complete and today’s announcement does not advance this much.

    • Hey Lain, I’m thinking that you missed my point. I must be more clear in the future. I know that this does not guarantee approval and that the pump version is not approved. I’m speaking in hypotheticals in the article. Should the pump version be approved it will show that the FDA approved the underlying drug. Should this take place (Not saying that it has yet), it will be easier to get the drug approved with other delivery systems in the future, not guaranteed, but it would lay the groundwork for follow on approvals. Yes, there is still a long way before the inhaled version is even submitted, but this is still great news for MNKD.

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