Tag - DDSS

Specialty pharmaceutical company Labopharm Inc. (Nasdaq:DDSS) announced before the opening today that the U.S. Food and Drug Administration had accepted its response for once-daily tramadol. The company said the FDA accepted the response as being a complete, Class 2 response. The action date assigned by the FDA is Jan. 2, 2009, under the Prescription Drug User Fee Act.

Once-daily Tramadol provides rapid and sustained drug release that maintains blood levels and provides a full 24 hours of pain relief, the company said.

In today’s pre-market trading, shares of Canada-based Labopharm are flat at $1.52. During the past 52 weeks, shares have ranged from $0.63 to $3.04.

Shares of Stemcells Inc. (Nasdaq: STEM) have appreciated on news this morning that the pharmaceutical company has successfully completed enrollment for a Phase I clinical trial of its treatment for Batten disease, a fatal disorder of the nervous systems. Shares are up $0.02, or 1%, to $2.46.

Shares of Canadian pharmaceutical company Labopharm Inc. (Nasdaq: DDSS) are higher following news over the weekend that it has received a notice of compliance from regulators for its pain management tablets and can now begin marketing. Shares are up $0.16, or 6%, to $2.89.

The Russell 2000 set a third consecutive record high close following news of strong U.S. job growth. The Russell 2000 added 6.27 points, or 0.74%, to close at a record 853.45. The Dow Jones Industrial Average gained 40.47 points, or 0.30%, to close at 13,668.11, improving on its record high on Wednesday.

Investors reacted to news that non-farm payrolls increased 157,000 in May, beyond economists’ projected rise of 145,000 jobs.

Shares of Canada’s Labopharm Inc. (Nasdaq: DDSS) are flat despite news after Thursday’s close that the U.S. Food and Drug Administration has sent it a letter stating that the painkilling drug tramadol is not efficient.  Adding to the pharmaceutical company’s woes is news that National Bank Financial has downgraded the company’s stock to “sector perform” from “sector outperform.”  Shares are at $6.31.

A wholly-owned subsidiary of Mineral Wells, Texas-based PHAZAR CORP. (Nasdaq: ANTP) has received a $0.97 million purchase order from a client in Spain for the production of four antenna systems.

Labopharm Inc. (Nasdaq: DDSS) shares down sharply following an announcement at the closing bell Thursday that the Toronto, Canada-based pharmaceutical company has received a second approvable letter from the Food and Drug Administration regarding the pain relief drug Tramadol. The letter said that Labopharm has not demonstrated the efficacy of its once-daily formulation of Tramadol, because the statistical methods the company used to analyze data from its clinical trials “did not adequately address missing data relating to subjects who dropped out of the trials.” In a press release, the company said the FDA did not explain why the statistical methods were inadequate. Labopharm said it seeks to clarify the issue with the FDA as soon as possible.

Great Lakes Dredge & Dock Corp. (Nasdaq: GLDD) are up after a bullish mention Thursday evening by MSNBC pundit Jim Cramer. The Illinois, Ill.-based business provides dredging, marine construction and demolition services.

Shares in DexCom, Inc. (Nasdaq: DXCM) are up following the announcement after Thursday’s closing bell that the FDA approved its seven-day continuous glucose monitoring device for people with diabetes. The San Diego-based medical devices maker said it plans to launch the monitoring device – called Seven – by the end of the summer.

Phazar Corp. (Nasdaq: ANTP) shares are soaring following the announcement Thursday evening that the company’s Antenna Products unit received a $0.9 million order from the Spanish telecom company Page Iberica S.A. The Madrid-based company ordered four Multiport Antenna Systems. Phazar said the order will be shipped in October for installation at a Spanish NATO site.

The following are the most actively traded companies in Friday pre-market trading among those with market capitalizations under $500 million:

Labopharm Inc. (Nasdaq: DDSS) said it received a second approvable letter from the U.S. Food and Drug Administration, which said the company has not shown the efficacy of its once-a-day formulation for tramadol. Tramadol is an analgesic for the treatment of moderate to severe pain. The FDA letter said the statistical methods used by Labopharm in clinical trials did not sufficiently address missing data about subjects who dropped out. Labopharm, based in Laval, Canada, said it seeks to talk with the FDA as soon as possible to find out the best way to address the issue and to move forward toward final approval. Shares of Labopharm were down $3.01, or 48%, to $3.30 in after-hours trading.

Other small caps making news in after-hours trading:

CRA International (Nasdaq: CRAI), a management consulting company, said results for the second quarter ended May 11 would be below expectations, and it lowered guidance for full fiscal 2007. The Boston, Mass.-based company now expects 2007 revenue growth in the 10% to 12% range and earnings per share growth of 12% to 17% above 2006. For the second quarter, CRA International said preliminary results showed revenue would be about $88 million, compared with $84 million in the same quarter last year; analysts had expected $96.79 million. Net income is expected at $0.53 per share, including a net tax benefit, compared with $0.55 the previous year and forecasts for $0.64. Shares of CRA International were down $8.89, or 17%, at $44.00 in after-hours trading.