Showing posts with label Repligen. Show all posts
Showing posts with label Repligen. Show all posts

Friday, June 22, 2012

Friday’s biggest gaining and declining stocks

Friday’s biggest gaining and declining stocksAtlanta, GA 6/22/12 (StreetBeat) -- Here are some of the most active stocks in U.S. trading Friday:

Gainers

Alexza Pharmaceuticals (Nasdaq:ALXA) rose 40% on Friday, rallying after the company said that it has resubmitted a new drug application for its Adasuve candidate with the Food and Drug Administration.

Harvest Natural Resources Inc. (NYSE:HNR) shares jumped 75%, Late Thursday, the energy company reached an agreement to sell some Venezuelan assets for about $725 million.

NPS Pharmaceuticals Inc. (Nasdaq:NPSP) shares added 11% after the company said it and partner Takeda Pharmaceutical have won support from a European regulatory committee recommending the companies’ treatment for short bowel syndrome.

U.S.-listed shares of Sony Corp. (NYSE:SNE) climbed 6%. The electronics and entertainment conglomerate reportedly is considering making an investment in fellow Japanese company Olympus.

Decliners

Protalix Biotherapeutics (AMEX:PLX) shares shed 7% after the company said that European medical authorities have ruled against recommending taliglucerase alfa, a treatment for Gaucher disease that Pfizer Inc. (NYSE:PFE) and Protalix have partnered on.

Repligen (Nasdaq:RGEN) shares fell 9% on Friday. Earlier, the company said that the FDA has requested more data on one of its drugs used for the treatment of pancreatitis.

Ryder System Inc. (NYSE:R) shares fell 11%. On Thursday the company issued a lowered outlook for its fiscal second quarter and full-year earnings.

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FDA rejects Repligen's (Nasdaq: REGN) imaging agent, shares drop

FDA rejects Repligen's (Nasdaq: REGN) imaging agent, shares dropAtlanta, GA 6/22/12 (StreetBeat) -- Repligen Corp (Nasdaq: REGN) said U.S. health regulators denied approval for its imaging agent to detect structural abnormalities in the pancreas, sending its shares down 10 percent.

The U.S. Food and Drug Administration has asked for additional efficacy and safety trial data to approve the agent, called RG1068, in a complete response letter.

Repligen said in April that it did not expect the FDA to approve the imaging agent as the regulator had canceled an advisory committee meeting to review the agent.

In the complete response letter, the regulator did not cite any deficiency with respect to the manufacturing, pharmacology or toxicology sections of the approval application.

The company's shares, which dropped 40 percent on April 26 when the company said it was expecting a rejection, were down 9 percent at $3.99 in morning trade on the Nasdaq. They touched a low of $3.95 earlier in the session.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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