|By PR Newswire||
|August 22, 2014 10:21 AM EDT||
CHICAGO, Aug. 22, 2014 /PRNewswire/ -- Zacks Equity Research highlights Epizyme (Nasdaq:EPZM-Free Report) as the Bull of the Day and Panera (Nasdaq:PNRA-Free Report) as the Bear of the Day. In addition, Zacks Equity Research provides analysis on Amicus Therapeutics (Nasdaq:FOLD-Free Report), Sanofi (NYSE:SNY-Free Report) and Shire (Nasdaq:SHPG-Free Report).
Here is a synopsis of all five stocks:
The biotech bull market is far from over due to several secular and macro drivers like an aging population, cash-rich "big pharma" facing patent cliffs forcing them to buy new drugs, and the incredible success of small companies doing innovative disease R&D.
One such small company making headlines lately is Epizyme (Nasdaq:EPZM-Free Report), a clinical stage biopharmaceutical company creating personalized therapeutics for patients with genetically defined cancers. Epizyme has built a proprietary product platform that the company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs.
HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme's targeted science seeks to match the right medicines with the right patients for a personalized approach to cancer treatment.
Writing for TheStreet.com this week, David Sobek summed up the pre-clinical data and early clinical observations from an ongoing Phase I trial...
"Epizyme reported the first clinical data on its blood cancer pipeline candidate EPZ-6438 at the ASH Lymphoma Biology Conference last week. The drug is designed to block a specific enzyme, EZH2, which when mutated, is involved in development of certain cancers, including forms of non-Hodgkins lymphoma (NHL).
Some "fast casual" eateries seem to have growing appeal and profits, like Chipotle, and some are really struggling like Panera (Nasdaq:PNRA-Free Report). I actually like Panera a lot -- best oatmeal raisin cookies, and I am an aficionado here -- but the stock has been in a sharp decline since its peak in Q1 above $190 and there's a good reason for it: falling profits.
In the past 90 days, 13 analysts have lowered full-year 2014 EPS estimates from $6.88 to $6.68. That's not a severe drop. But it is part of a longer trend where those estimates were over $8 last year.
And 2015 earnings projections have come down over 7% from $7.71 to $7.15. 2015 had started out last year close to $10.
Amicus (FOLD) Soars on Drug Trial Results
Shares of Amicus Therapeutics (Nasdaq:FOLD-Free Report) soared 20.4% after the company announced positive data from its second phase III study (Study 012) on the oral small molecule chaperone migalastat HCl in Fabry patients with amenable mutations.
The phase III study is evaluating the use of oral migalastat to standard-of-care enzyme replacement therapies (ERTs) − Sanofi's (NYSE:SNY-Free Report) Fabrazyme and Shire's (Nasdaq:SHPG-Free Report) Replagal − for Fabry disease. Eighteen-month data from the phase III study revealed that migalastat successfully met both the primary endpoints of comparability to ERT on key measures of kidney function. Additionally, the candidate demonstrated low and stable plasma lyso-Gb3 levels in patients who switched from ERT to migalastat.
In April this year, Amicus had announced positive results from its first phase III study (Study 011) on migalastat. Shares at that time had gained over 20% on the news. Migalastat had shown a statistically significant reduction in kidney interstitial capillary GL-3 at month 12 as compared to placebo.
Amicus plans to submit the marketing application for migalastat next year. We are encouraged by the positive data on migalastat considering that it is one of the key candidates at Amicus. We believe that post approval the drug could capture ERT's market share which is valued at over $1 billion. Investor focus is expected to remain on migalastat going forward.
Amicus, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy).
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