NEW YORK (
) -- Shares of
were weak in late traded on Thursday after the Valencia, Calif.-based drug developer said it's laying off 41% of its workforce in the wake of the mid-January setback in its efforts to secure regulatory approval of its proposed inhalable diabetes drug Afrezza.
The company also reported its fourth-quarter results, saying it lost $38.3 million, or 33 cents a share, in the three months ended Dec. 31, narrower than its loss of $59.5 million, or 53 cents a share, in the same period a year earlier. In Form 8-K filing with the
Securities and Exchange Commission
, MannKind gave some additional color on the layoffs, saying it expects to reduce its workforce to 257 employees by mid-April, implying 178 employees are being let go.
"We are requesting guidance from the FDA in order to clarify the regulatory path for AFREZZA and we will promptly implement their recommendations as soon as possible after our requested meeting," said Alfred Mann, the company's chairman and CEO, in a press release. "In the meantime, we are restructuring our organization to be focused on securing the approval of AFREZZA, which today resulted in the elimination of approximately 41% of our workforce."
The stock was last quoted at $4.56, down 10%, on volume of roughly 380,000, according to
. The shares are down 45% in the past year with much of that decline coming on Jan. 20 after the
Food and Drug Administration
requested MannKind conduct two additional clinical trials of Afrezza.
MannKind also said in its Form 8-K that it's terminated a supply deal for its human insulin formation with
Organon unit because of the delay in marketing approval for Afrezza. The company is now on the hook for a termination fee that it's currently estimating will be $22.7 million if Organon is unable to sell the insulin to other parties.
( VITA) was rising in extended trading after the Malvern, Pa.-based company was the recipient of positive regulatory news about its Vitoss bone graft product.
The company said after the close that it's received 510(k) clearance from the Food and Drug Administration to market Vitoss BA Bimodal for use in the extremities, pelvis and posterolateral spine, according to a press release.
The stock was last quoted at $2.70, up 23%, on volume of around 130,000. Based on a regular session close at $2.20, the shares were down more than 40% in the past year; although they've rebounded a good bit since scraping a 52-week low of $1.60 on Sept. 1.
OrthoVita said it expects to launch sales of Vitoss BA Bimodal in the United States nine to 12 months after its launch of Vitoss BA2X, which it plans to introduce for commercial sales next week.
fell sharply after the closing bell as investors reacted to a below-consensus fourth-quarter profit and a light outlook for the current quarter.
The Seattle-based online diamond and jewelery retailer said it earned $6.2 million, or 41 cents a share, in the three months ended in December as net sales rose 11.5% year-over-year to $114.8 million. While the top-line number was ahead of the consensus view of $110.6 million, the average estimate of analysts polled by
was for earnings of 43 cents a share.
For its fiscal first quarter ending in March, Blue Nile forecast earnings of 14 to 16 cents a share on sales of between $76 million to $78.5 million. Wall Street's current expectation is for a profit of 20 cents a share in the quarter on sales of $79.7 million.
The stock was last quoted at $56.14, down 12%, on volume of around 360,000, according to
. After closing the regular session at $63.66, rising more than 5% ahead of the report, the shares were up about 19% in the past year, hitting a 52-week high of $63.72 on Feb. 7.
Blue Nile is known for being one of the more heavily shorted stocks on Wall Street. According to
data, 5.1 million shares were being held short as of Jan. 14.
Other stocks making dramatic moves in late trades included
, which fell more than 12% on volume of 900,000 following a
, which gained 11% on volume of less than 300,000 after it
Chipolte Mexican Grill
, which advanced 9% on volume of more than 600,000 after its
Written by Michael Baron in New York.
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