MannKind Corporation (NASDAQ:MNKD) shares plunged as much as 12.81% to $5.99 in the early trading session Monday after the company revealed that the USFDA has delayed the decision on its inhaled insulin treatment Afrezza. Shares were down as much as 22% in pre-market trading today. The Food and Drug Administration has delayed the review date from April 15 to July 15. The review is a part of the Prescription Drug User Fee Act.
MannKind’s treatment much easier to use
MannKind Corporation (NASDAQ:MNKD) shares almost doubled last week when an advisory panel to the USFDA unanimously recommended Afrezza for approval. The committee reviewing the drug recommended with 13-1 votes for type-1 diabetes, and 14-0 votes for type-2 diabetes that Afrezza be granted approval. The treatment had previously been rejected multiple times as the FDA raised questions over its safety and effectiveness.
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MannKind Corporation (NASDAQ:MNKD) said the new review date will give regulators sufficient time to review the information it had submitted. A few members in the advisory panel had opined that the treatment needed to go through longer-term studies to find out potential side-effects and the risk of lung cancer. Afrezza is a whistle-size inhaler that delivers insulin directly to the lungs. Therefore, it is a lot easier to use than conventional injected insulin. The delay wasn’t a big surprise for Wall Street. Some analysts were expecting a delay given concerns over the drug’s safety and effectiveness
Approval of the drug would change MannKind’s fortunes
If the FDA approves it, Afrezza will become the first inhaled diabetes treatment in the U.S. since 2006. MannKind Corporation (NASDAQ:MNKD) has poured in well over $500 million over the past three years on testing, re-testing and conducting clinical trials to get it approved. Approval of the drug would change the fortunes of the Valencia, California-based biotech company. According to the American Diabetes Association, the U.S. diabetes market has swelled from $174 billion in 2007 to more than $245 billion in 2012.
MannKind Corporation (NASDAQ:MNKD) shares were still down 6.71% to $6.41 at 10:17 AM EDT.