MannKind Corp. (NASDAQ: MNKD) has a serious victory within its grasp. The company has struggled to get its Afrezza inhalable insulin to market for years, and that dream now seems to be within its grasp. Shares were at one point almost doubling on the news.
Please Note: This story was updated throughout the day due to price and volume changes based on the severe percentage move, the short interest and options trading. Wednesday could have been a 100 million MannKind share day, but it fell just short.
MannKind announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to one to recommend that Afrezza be granted FDA marketing approval to improve glycemic control in adults with type 1 diabetes. This same FDA panel also voted 14 to none to recommend that Afrezza be granted FDA marketing approval to improve glycemic control in adults with type 2 diabetes.
The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its approval review of Afrezza is April 15, 2014. This means that within two weeks we should know if Afrezza is to be approved, barring any delays on the part of the FDA. If approved, Afrezza will be the first ultra-rapid-acting mealtime insulin therapy available in the United States.
Investors and those who will sign up for Afrezza prescriptions need to keep a couple things in mind here. Many FDA approvals have failed to come, even after FDA panels strongly recommended an approval action. Another serious issue to remember is that the FDA has not exactly been considered a MannKind friend in recent market history.
Afrezza is an inhaled powder administered at the start of a meal, which aims to improve glycemic control in adult patients with type 1 or type 2 diabetes. This powder is delivered by an inhaler and dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. The company shows that peak insulin levels are achieved within 12 to 15 minutes, versus 45 to 90 minutes for injected rapid acting insulin analogs and 90 to 150 minutes for injected regular human insulin.
MannKind has spent more than $500 million in the past three years alone trying to get Afrezza approved. Testing and retesting comes at a serious price, and the FDA process that delayed and drove up the testing costs will certainly increase the price of Afrezza, compared to if this would have been approved initially.
MannKind shares had been halted at $4.02 ahead of the news. Less than two weeks ago this was north of $6.00, but many market participants feared the worst. As a reminder, MannKind’s short interest in mid-March was a whopping 63.558 million shares. That would take more than 10 days to cover.
As a sign of faith here on why this is potentially so large, the American Diabetes Association projected a year ago that the total costs of diagnosed diabetes in 2012 was $245 billion. That figure was $174 billion in 2007. Literally billions of dollars are up for grabs here.
As a reminder, there are also MannKind warrants traded over the counter.
MannKind shares were indicated up almost 100% at $8.00 in the very early-bird trading indications Wednesday, and the closing market cap after the rush was $2.5 billion based upon a $7.00 close. The biggest question now is whether MannKind shares can double again if approved? Watch the options trading over the next two weeks to find out what sort of pricing occurs going into that PDUFA date. That may seem to be a stretch even to ask, but Afrezza is almost certain to become a blockbuster if approved.
UPDATE 5 – CLOSING BELL: MannKind just missed the 100 million share mark. The stock closed up 74% at $7.00 on over 96 million shares.
UPDATE 4: MannKind shares were up 74% at $7.00 on more than 74 million shares as of 1:18 p.m EST. It looks like 100 million shares is more than just possible on Wednesday. MannKind is also close to the 150,000 combined contract volume of the weekly and monthly April put contracts when all tallied up.
UPDATE 3: MannKind shares were up 80% at $7.25 on almost 40 million shares right after 10:00 a.m. EST. Also, April weekly and monthly put and call options volume is through the roof, with some 50,000 contracts already trading.
UPDATE 2: MannKind shares were up 92% at $7.73 in active trading of more than 7 million shares as of 9:00 a.m. EST.
UPDATE 1: MannKind shares traded up 95% at $7.85 on more than 4 million shares as of 8:10 a.m. EST.