NEW YORK (
) -- Shares of
plummeted in after-hours action on Wednesday after the
Food and Drug Administration
delayed a decision on the regulatory status of its Afrezza treatment for diabetes.
Valencia, Calif.-based MannKind said it's
received a complete response letter
from the FDA regarding Afrezza, a quick-acting form of insulin that's
meant to be inhaled.
The letter means the FDA has additional questions about Afrezza's new drug application. As a result, the agency has requested two additional clinical trials -- one for patients with type 1 diabetes and one for patients with type 2 diabetes -- be conducted using the latest version of the company's MedTone inhaler.
While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program," said Alfred Mann, the company's chairman and CEO, in a statement. "We remain committed to working with the FDA to make AFREZZA available to people with diabetes."
The stock was last quoted at $5.16, down 43.4%, on volume of 2.6 million, according to
. The shares had already fallen more than 7% to $9.11 in the regular session with volume running more than twice its trailing three-month daily average of 3 million. The stock sank as low as $4 in extended trades, well below its 52-week low of $4.76 from late May 2010.
was a bright spot in late trades after it
topped Wall Street's expectations
for its quarterly results after the closing bell.
The shares advanced 3.1% to $30 on volume of 3.3 million in extended trades as eBay said it earned $683.8 million, or 52 cents a share, for the three months ended Dec. 31 on a non-GAAP [generally accepted accounting principles] basis. Revenue increased 5% on a year-over-year basis to $2.5 billion.
The performance, which eBay attributed to "solid productivity, strong growth, and a lower tax rate," was ahead of the average estimate of analysts polled by
for a profit of 47 cents a share in the December period.
eBay also forecast non-GAAP earnings of 44 to 46 cents a share for its fiscal first quarter and $1.90 to $1.95 a share for the full year. Wall Street's current consensus estimates are for profits of 45 cents and $1.85 a share in the respective periods.
eBay's stock has appreciated almost 27% in the past 52 weeks, although it's pulled back since hitting a 52-week high of $31.64 at the end of November. Of the 32 analysts covering the shares, the majority -- 18 -- had hold ratings in place ahead of the report.