Pompano Beach, Fla. (January 4, 2013)
Amicus Therapeutics, Inc. (NASDAQ: FOLD) shares jumped 12.73% to $3.71 after the company announced positive preliminary results from all 4 dose cohorts in a Phase 2 study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme® and Lumizyme®). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are the first and only approved treatments for Pompe disease.
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Johnson & Johnson (NYSE: JNJ) stock gained 1.19% to $71.57. The company will shortly begin shipping supplies of the first new drug developed for tuberculosis in half a century, following US regulatory approval this week. Paul Stoffels, joint head of Janssen, the US healthcare group’s pharmaceutical division, pledged to make the medicine available affordably to patients around the world rather than focusing on charging high prices for a drug that could help revolutionise treatment.
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Eli Lilly & Co. (NYSE: LLY) shares climbed 3.90% to $51.66. The company expects its profit to rise in 2013 on potentially modest sales growth, even as the drug maker grapples with sales erosion from one of the steepest patent cliffs in the industry.
For 2013, Lilly expects full-year earnings of $4.03 to $4.18 a share, or $3.75 to $3.90 a share excluding the impact of income associated with the termination of a diabetes-drug partnership with Amylin Pharmaceuticals, which was acquired by Bristol-Myers Squibb last year. The 2013 forecast excludes the one-time impact associated with 2012 that will be recorded this year from the fiscal-cliff legislation.
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Accuray Incorporated (NASDAQ: ARAY) shares declined 19.76% to $5.44 in the early hour after ARAY’s stock was downgraded by equities researchers at JPMorgan Chase from a “neutral” rating to an “underweight” rating in a report issued today.
The company announced preliminary results for the second quarter of fiscal 2013 that ended December 31, 2012 and updated guidance for fiscal 2013. Preliminary consolidated GAAP revenues for second quarter fiscal 2013 are expected to be in the range of $72 million to $75 million and total non-GAAP revenue of $72 million to $75 million. By comparison, for the second quarter of fiscal 2012, total GAAP revenue was $106.4 million and total non-GAAP revenue was $102.9 million.
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Repros Therapeutics Inc. (NASDAQ: RPRX) stock fell 1.55% to $15.20. The company reported top line results from its Phase 2 study of vaginally administered Proellex in the treatment of symptomatic fibroids. The results from the study suggest the 12 mg dose may provide clinical benefit to women suffering from symptomatic uterine fibroids. The Company plans to request an end of Phase 2 meeting with the FDA as soon as practicable.
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