MannKind (MNKD) Stock: Gains On Brazil Approval

MannKind Corporation (NASDAQ: MNKD) is catching the attention of investors this morning after announcing the approval of Affrezza in Brazil. As a result of the approval, the stock is up more than 6% in the pre-market as excited investors snap up shares.

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MNKD Announces Brazilian Approval

The announcement that the Brazilian Health Regulatory Agency, also known as ANVISA, has approved Afrezza was made via press release early this morning. This approval allows the commercialization of the treatment in the region, which is expected to begin as early as the fourth quarter of this year.

To get to commercialization, the company must go through a pricing registration process by CMED, but that is expected to take place relatively quicky.

What Is Afrezza

Affrezza is the flagship product at MannKind. The product is a rapid-acting orally inhaled insulin therapy. In clinical studies and real-world use, the treatment has been proven to improve glycemic control in adult patients with diabetes mellitis.

The treatment is a dry insulin powder that is inhaled through a small, discreet inhaler. Patients generally take the treatment at the start of a meal. From there, the treatment ddissolves rapidly in the lung and passes into the bloodstream in less than a minute, leading to glucose-lowering effects in just a few minutes after administration.

Why This Is Such A Big Deal

At the moment, diabetes mellitus is estimated to affect around 425 million patients around the world. This includes an estimated 12 million+ patients in Brazil alone according to the International Diabetes Federation.

As a result of the approval, MNKD will soon have the ability to access to this large audience, offering up the opportunity to significantly expand revenue. Of course, investors want to see growth, and that’s exactly what this news has the potential to lead to.

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Management Commentary

The regulatory approval of Afrezza in Brazil is an important milestone for MannKind and our partner Biomm. It not only represents our first international approval of Afrezza, but more importantly, we now have the opportunity to bring a novel mealtime insulin therapy to patients in a country with one of the highest prevalence of diabetes in the world, according to the International Diabetes Federation. – Michael Castagna, Chief Executive Officer of MannKind Corporation.

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to follow MNKD closely. In particular, we’re interested in following the pricing process and seeing if the company does hit its commercialization goal of launching by the fourth quarter. It will also be interesting to see just how much this approval affects revenue over the next year. Nonetheless, we’ll follow gthe story closely and bring the news to you as it breaks.

What Do You Think?

Where do you think MNKD is headed moving forward? Join the conversation in the comments below!

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