MannKind Corporation (NASDAQ: MNKD) is having an incredibly strong start to the trading day this morning, and for good reason. The company announced that the United States Food and Drug Administration has approved a label update for the prescription drug known as Afrezza. With the positive update, investor excitement is high, sending the stock upward and prompting our partners at Trade Ideas to alert us to the gains. At the moment (8:56), MNKD is trading at $2.30 per share after a gain of $0.13 per share (5.99%) thus far today.
MNKD Gains On Label Update
As mentioned above, MannKind Corporation is having a strong day in the market today after announcing that the FDA has approved an update to the Afrezza label. The update was the result of new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions on June 2016. Here are the key highlights from the label update:
- Study data that describe the time-action profile by dosage strength is now included.
- MNKD now has the ability to provide clarity on “Starting” and “Adjusting” the mealtime dose.
- Finally, the new label includes an updated pregnancy and lactation section to conform to current FDA label guidance.
In a statement, Satish Garg, MD, MBBS, DM – Barbara Davis Center for Diabetes – University of Colorado, had the following to offer:
“These data articulate the rapid-acting nature of Afrezza to address post-prandial hyperglycemia, setting it apart from other mealtime options available to help patients maintain greater control over their blood glucose levels.”
The Label Change In More Detail
There are several key changes that have been made to the label for Afrezza. Here are the details offered in the press release published by MNKD early this morning:
- Clinical Pharmacology: The new label offers data from a randomized, controlled, six-treatment, crossover dose-response study that compared Afrezza to Lispro. The data includes time to peak effect and time for effect to return to baseline to ensure that patients are dosing the treatment properly.
- Dose Administration – MNKD informed investors that the Dosing Information section of the label has been updated. The new section includes a “Step 1” that informs patients on how injected mealtime insulin should be initially dosed on Afrezza. “Step 2” was also added to highlight that mealtime dose adjustments may be required.
- Use In Specific Populations – Finally, MNKD informed investors that the Pregnancy and Lactation sections of the label have been updated to conform with current FDA guidance. The update was designed to provide healthcare providers with more clarity on the risk benefit side of the coin.
In a statement, Michael Castagna, CEO at MNKD, had the following to offer:
“Available data suggests approximately 70% of people living with diabetes on insulin are not at HbA1c goals of <7%2… We firmly believe that in order for patients to achieve better HbA1c goals, control of mealtime insulin that provides doctors and patients with the flexibility necessary to help them achieve glycemic control”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on MNKD. In particular, we’re interested in following the story surrounding the new label update and hoping that further clarity on the label leads to increased sales, as healthcare providers may be more apt to prescribe the treatment. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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