Investors are racing to buy MannKind Corporation (NASDAQ:MNKD) shares following the news that the FDA has approved a labeling revision for the company’s diabetes treatment Afrezza. The Afrezza prescribing information will now include new clinical data that was presented at the American Diabetes Association’s 76th Scientific Sessions in June 2016.
MannKind shares are up nearly 6% to $2.30 in pre-market trading Monday.
Key highlights of the label update:
- Inclusion of study data that describe the time-action profile by dosage strength, showing first measurable effect starts in approximately 12 minutes, peak effects occur approximately 35 to 45 minutes after dosing and return to baseline after approximately 1.5 to 3 hours for the 4 and 12 unit cartridges respectively.
- Clarity on “Starting” and “Adjusting” mealtime dose.
- Updated pregnancy and lactation section to conform to current FDA label guidance.
“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,” said Satish Garg, MD, MBBS, DM — Barbara Davis Center for Diabetes (BDC) – University of Colorado.
Details of the label update:
- Clinical Pharmacology (Section 12): The basis of this label change comes from a
randomized, controlled, six-treatment, crossover dose-response study comparing Afrezza
to the rapid-acting insulin analog, lispro, in 30 patients with type 1 diabetes. The data
highlighted below demonstratesthe importance of understanding the time to peak effect
and time for effect to return to baseline.
- Dosage and Administration (Section 2): The Dosing Information section has been updated with “Step 1” to inform how patients on injected mealtime insulin should initially be dosed on Afrezza (Figure 1). Additionally, “Step 2” was added to highlight that mealtime dose adjustments may be required based on the individual metabolic needs and glycemic control goals.
- Use in Specific Populations (Section 8): The Pregnancy and Lactation sections of the label have been updated to conform to the current FDA label guidance. These areas have been configured to provide healthcare providers with clearer risk benefit information for informed decision making in these populations.
On the ratings front, Maxim Group analyst Jason Kolbert reiterated a Buy rating on MNKD, with a price target of $4.00, in a report issued on September 29. The current price target represents a potential upside of 84% from where the stock is currently trading. According to TipRanks.com, Kolbert has a yearly average loss of 9.3%, a 35% success rate, and is ranked #4628 out of 4676 analysts.
MannKind is a biopharmaceutical company. It focuses on the discovery, development and commercialization of therapeutic products for diseases, such as diabetes and cancer.