MannKind Corporation (NASDAQ:MNKD)
MannKind Corporation (NASDAQ:MNKD) shares gained 40.1% after the U.S. Food and Drug Administration approved a favorable label change for Afrezza. Human Insulin, Afrezza, is now approved for glycemic control in adult patients with type 1 and type 2 diabetes. According to the company, it is the only inhaled rapid-acting mealtime insulin available in the United States.
The biopharmaceutical company has also confirmed that it successfully exchanged new common stock for outstanding warrants issued last year. The exchange strengthened investors’ confidence as it showed the company’s commitment to cleaning up opportunities for capital flexibility.
MNKD Stock Performance
MannKind Corporation (NASDAQ:MNKD) has gained more than 100% since the start of the month. However, the stock is up by more than 30% for the year. The stock is currently trading at 14-month high and traders are waiting to see if it will continue to rise after registering a new 52 week high of $6.51 a share.
Afrezza’s new label has revitalized investor confidence on the stock. The biotech company has been under pressure as investors reacted negatively to anemic sales reports. However, the label change should unlock the product’s blockbuster potential.
Afrezza New Label
The new label update includes data that describes the action profile by dosage strength as well as clarity on starting and adjusting mealtime dosage. To conform with current FDA guidance, the label also includes updated pregnancy lactation section.
“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.
Mannkind’s Financial Woes
MannKind Corporation (NASDAQ:MNKD) needs to capitalize on the new label if it is to continue rising higher in the market. The company still faces a string of changes after exiting the recent quarter with only $44 million in cash. Observers question if that amount will be sufficient to support operations going forward.
The company may have to look for additional funds to be able to ramp up the Afrezza commercial launch. Investors may wish to consider bracing themselves for secondary offerings given the spike in MNKD stock.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.