Shares of MannKind Corporation (NASDAQ: MNKD) slumped more than 43% in Thursday's pre-market trading after the company announced that it has received a complete response letter from the U.S. Food & Drug Administration regarding the New Drug Application for AFREZZA Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
Shares of Wendy's/Arby's Group, Inc. (NYSE: WEN) surged more than 8% in pre-market trading after the company announced that it is exploring strategic alternatives for Arby's Restaurant Group, Inc., including a sale of the brand. UBS Investment Bank is assisting in the process. Arby's is the second-largest quick-service sandwich chain in the U.S. with nearly 3,700 restaurants. Arby's restaurants specialize in slow roasted and freshly sliced roast beef sandwiches as well as Market Fresh(R) deli-style sandwiches, toasted subs and salads, all with the convenience of a drive-through.
Shares of Cytori Therapeutics, Inc. (NASDAQ: CYTX) rallied more than 6% in Thursday's pre-market trading after the company announced that it has received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs), processed by the Celution(R) One System, in the treatment of patients with acute heart attacks. This is the first country and trial-center approval for ADVANCE. Additional country and trial-center approvals are anticipated throughout Europe during the first half of 2011. One of the goals of the trial is to expand the Celution System CE Mark to include acute heart attack claims and to provide economic data to justify its implementation and reimbursement.
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