Shares of Cardica (NASDAQ:CRDC) climbed in Thursday’s pre-market session, after the developer of endoscopic microcutter products said it received 510(k) clearance from the U.S. Food and Drug Administration for its MicroCutter XCHANGE 30 white cartridge and for an additional plastic material contained within the MicroCutter XCHANGE 30 blue cartridge for use in medium-thickness tissue.
The 510(k) clearance for the MicroCutter XCHANGE 30 white cartridge is “for the stapling of thin tissue for use in multiple open or minimally invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix,” the company said. It comes after the MicroCutter XCHANGE 30 device received FDA clearance in January. Following these clearances, Cardica said it doesn’t have any other submissions pending at the FDA. CRDC was up 8.1% at $1.20 in recent pre-market trading. It has a 52-week range of $0.88 to $1.61.
Salix Pharmaceutical (NASDAQ:SLXP) has acquired the worldwide rights to RedHill BioPharma’s (RDHL) encapsulated formulation for bowel preparation and rights to other purgative developments. Salix will make an upfront payment of $7 million to RedHill and $5 million in subsequent milestone payments.
Salix will also pay tiered royalties on net sales. The two companies also agreed on potential strategic collaboration regarding certain other Salix products in specific territories. “We believe the availability of a tasteless solid oral formulation bowel prep, if approved by the FDA, could potentially go a long way in helping to increase patient compliance and to ease patient burden associated with bowel cleansing prior to various medically important abdominal procedures,” Salix CEO Carolyn Logan said in a statement. SLXP closed higher 0.1% on Wednesday. Earlier in the day it reached an all-time high of $110.93. RDHL was up nearly 3% at $13.55 in recent pre-market trade.
Shares of Chico’s FAS (NYSE:CHS) fell in Thursday’s pre-market session, after the women’s clothing retailer reported it swung to a fiscal Q4 loss and posted adjusted earnings and revenue below analysts’ expectations as same-store sales fell and increased promotional activity hurt margins. CHS was down 4% at $17.28 in recent pre-market trading. It has a 52-week range of $15.27 to $19.95.
For the quarter ended Feb. 1, the company posted a net loss of $348 million, or break-even earnings per share, compared with a prior-year profit of $31.5 million, or $0.19 per share. Excluding one-time items, it earned $0.04 per share in the latest quarter, down from $0.20 per share a year earlier and well below the $0.16 per share analysts were expecting on average according to Capital IQ.
Total net sales fell 6.4% to $610.2 million, missing analysts’ mean estimate of $658 million. Comparable sales decreased 3.4%, reflecting “lower average dollar sale and transaction count, primarily as a result of the impact of a highly promotional environment in response to lower traffic,” the company said. Gross margin was 50.7% of net sales, down from 53.2% a year earlier, again reflecting the increased promotional activity in response to lower traffic.
Electric-energy company Dynegy (NYSE:DYN) reported a narrowed Q4 loss as adjusted EBITDA from both its gas and its goal segments improved. The company posted a Q4 net loss of $91 million, compared with a loss of $107 million a year earlier. It didn’t break out per-share earnings figures or revenue on a quarterly basis. Total adjusted EBITDA was $63 million, compared with a loss of $42 million for the same period in 2012. It benefited in the latest quarter from a $27 million increase in adjusted EBITDA from the coal segment and a $69 million improvement in gas segment adjusted EBITDA and the addition of the new IPH segment in December 2013. For 2014, the company forecast adjusted EBITDA of $300 million to $350 million. Shares were inactive in recent pre-market trading after closing Wednesday at $23.32, in a 52-week range of $18.11 to $25.18.