MannKind Soars on FDA Committee Vote, Investors Bet On Coming Approval

Diabetics will soon be able to inhale their medication instead of relying on insulin shots. And the news has MannKind, $MNKD, investors breathing easy this morning.

Shares of the biotech firm opened 93% higher after a U.S. Food and Drug Administration committee voted unanimously to recommend its AFREZZA inhaled insulin to treat people with type 2 diabetes. All except one of the committee members voted to approve AFREZZA for type 1 diabetes.

The recommendations of the Endocrinologic and Metabolic Drug Advisory Committee weigh heavily in FDA decisions. The drug-approval board has until April 15 to finish its AFREZZA review and decide on final approval.

On Wednesday, many investors on said approval was now a foregone conclusion. Sentiment is 96% bullish, according to StockTwits’ analytics.

$MNKD I'm still LONG!!! Approval is inevitable!!

— Kyle Cooper (@Kylecooper95) Apr. 2 at 08:48 AM

$MNKD AdComm nearly unanimous voting to approve. Are you seriously doubting this gets approved?

— Gary Evans (@wengang1) Apr. 2 at 08:50 AM

The U.S. insulin market is expected to hit $13.2 billion in 2017, according to research consultancy RNCOS. Cashtaggers believe that MannKind’s drug could quickly become dominant as inhaled medicine would be preferable to regular injections for many diabetes sufferers.

$MNKD no needles is a life changer

— NiteKnight (@NiteKnight) Apr. 2 at 08:50 AM

Investors relief was palpable on the StockTwits’ stream. The stock had sunk 32% in the past five days as investors questioned whether the FDA committee would recommend the drug and if their bet on MannKind would become worthless. Afrezza is MannKind’s main drug. It has little else in the pipeline.

$MNKD anybody who didn't hold a bunch through adcom should have to pay a pain & suffering tax to those of us who did if they buy today.

— Rich (@flowomo) Apr. 2 at 09:13 AM

Briefing documents for the committee had seemed to indicate that reviewers had serious concerns about the drug that would block approval. Reviewers stressed that the insulin inhaler had respiratory side effects. One reviewer wrote that more data was needed to prove that the drug was as effective for Type I diabetes patients as rapid, acting insulin shots.

In a note to clients, Piper Jaffray analysts said the drug faced an “uphill battle” to approval for Type I diabetes. On March 31, they downgraded the stock to “underweight” and slapped on a $1.50 price target.

MannKind traded above $7.50 this morning. Some cashtaggers called for more gains.

$MNKD I'm not going to sell one share! this is going to the moon.. next catalysts: FDA approval (15th April) then partnership, then buyout..

— Stockjoint (@Stockjoint) Apr. 2 at 08:50 AM


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