Mannkind (NASDAQ:MNKD) Shares Crushed on Request for Additional Trials of Afrezza

Mannkind (NASDAQ:MNKD) shares are getting hammered today on the news the FDA has requested more trials for Afrezza.

"The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone inhaler," said Mannkind in a statement.

Mannkind CEO Alfred Mann added, "We plan to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."

The MedTone inhaler is a next-generation inhaler requlators said the company must use in trials to generate more data on how it performs and is used, as well as how its handled and stored.

MannKind was trading at $5.36, down $3.75, or 41.16 percent, as of 11:06 AM EST.

MannKind's (NASDAQ:MNKD) Afrezza FDA Delay a Neutral Event

MannKind (NASDAQ:MNKD) would have liked to have had the FDA give them a positive decision concerning Afrezza, but Wells Fargo (NYSE:WFC), while acknowledging it could cause problems if the delay is for a long period of time, considers it a neutral event over the short term.

Wells said, "We maintain our rating on the potential for Afrezza. Though a positive decision would have been preferred, we think a short delay by the FDA is better than a complete response letter (CRL) and should be viewed as a generally neutral outcome. Additional approval delays could become problematic but we think MNKD should be able to fund operations through 2011 with cash and credit currently available."

Wells Fargo maintains an "Outperform" rating on MannKind, which closed Tuesday at $8.23, gaining $0.26, or 3.26 percent. Wells has a price target range of $11 to $13 on them.