Shares of NXP Semiconductors NV (NXPI) are fractionally higher (0.26% to $111.00) in pre-market trading Thursday, after the company this morning announced a joint development of intelligent packaging solutions with with Stora Enso. The development will focus on integrating RFID into packages for consumer engagement and supply chain purposes.
Shares in the $25.85 billion market cap company are up 77.39% year-over-year and off about 0.39% from their May 27, 2015, $111.14 52-week high.
Shares of AMAG Pharmaceuticals, Inc. (AMAG) lost over 3% to $64.50 in the pre-market session Thursday. The company today announced that it has received a response letter from the FDA regarding its manufacturing supplement seeking approval for a single-dose vial of Makena. A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form.
“We believe that the approval of a single-dose vial of Makena could provide important added flexibility and efficiency for our customers, with the assurance of a product that meets the FDA’s strict quality requirements for sterile injectables,” stated William Heiden, CEO of AMAG. “We continue to plan for a commercial launch of the single-dose vial now in the fourth quarter of 2015. Importantly, we do not anticipate today’s news changing our financial outlook for 2015.”
On valuation measures, AMAG shares are currently priced at 12.26x this year’s forecasted earnings. Ticker has a t-12 price/sales ratio of 10.35. EPS for the same period registers at $5.44.
Shares of Great Basin Scientific, Inc. (GBSN) were higher marginally ($0.04 to $3.81) in pre-market hours after the molecular diagnostics firm announced continued expansion of the customer base utilizing the Great Basin sample-to-result molecular diagnostic technology during April and May. The company reported a total of 112 revenue-generating customers in the U.S. as of May 27, 2015, a 10.3% increase over the 101 customers reported as of the prior quarter ending March 31, 2015. Great Basin said active and scheduled customer evaluations, representing the company’s sales pipeline, are 44 as of May 27.
Shares of Xbiotech Inc (XBIT) were up 5% to $21.02 this morning on news that the FDA has lifted its clinical hold from the company’s IND, enabling launch of its therapy for S. aureus infections.
XBiotech was placed on clinical hold while it worked with the agency to prepare its novel therapy and manufacturing process for human studies. XBiotech said it will now begin enrollment of approximately 52 patients in a Phase 1/2 randomized, placebo-controlled, dose escalation study, which will evaluate safety and efficacy of the therapy to treat serious S. aureus infections.
John Simard, the company’s CEO said in a statement, “We are grateful to the FDA for working very closely with us to launch the first of our new infectious disease therapies. It would be difficult to overstate the potential impact this new therapy could have on how therapies are developed and used to treat infections.
Shares of FXCM Inc. (FXCM) are up by 1.32% to $1.53 in pre-market trading on Thursday morning, after the company said it sell FXCM Hong Kong to Rakuten Securities, Inc., a top 5 FX broker in Japan, for approximately $36 million.
“We are pleased to extend our relationship and announce another transaction with Rakuten Sec through the sale of FXCM Hong Kong,” commented Drew Niv, CEO of FXCM. “This is another positive step towards FXCM completing its plan to sell non-core assets and repay the Leucadia loan.”
In the past 52 weeks, share of the New York-based online forex provider have traded between a low of $1.22 and a high of $17.44. Over the past 5 trading sessions the stock has gained 8.63%. Ticker is down 88.35% year-over-year and 90.89% year-to-date.
The chart below shows where the stock has traded over the last year.