This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Biotech Stock Mailbag: Keryx, Sangamo, Threshold and Amarin

Stocks in this article: KERX SGMO THLD AMRN AEZS CELG

The difference in phosphorous levels between Zerenex and placebo needs to be statistically significant in order for the study to be deemed positive.

Keryx has already run shorter phase III studies of Zerenex demonstrating lowered serum phosphorous levels so there's little reason to believe the long-term study will produce contradictory results.

Zerenex is an iron-based phosphate binder, which is different from competing drugs. Dialysis causes patients to become anemic, requiring treatment with intravenous (IV) iron and erythropoietin-stimulating agents (ESAs) like Amgen's Epogen. Keryx believes Zerenex can grab a significant share of the phosphate binder market if the drug boosts patient iron stores enough to reduce IV iron and/or ESA use.

Along with measuring serum phosphate, the long-term Zerenex study also assesses changes over time in iron levels (ferritin and TSAT levels) and changes in IV iron and ESA use. These are key secondary endpoints of the study. Note, the study has 13 pre-specified secondary endpoints, according to a detailed summary published in Hemodialysis International last year.

Wait to see the iron data that Keryx discloses, but I'd be cautious about over-interpretation. The study does not control for either IV iron or ESA use, which makes it harder for Zerenex to show a benefit. Zerenex is iron-based so it will be no surprise to see improvements in ferritin and TSAT levels, but at what cost? Iron causes lots of constipation, so make sure to pay attention to the safety data and toxicities reported by Keryx.

Also, there will be considerable debate about what constitutes a meaningful reduction in IV iron and ESA use -- if any is observed. That's a question for the FDA to settle when it comes to putting together Zerenex's label. Given the "modest" iron benefit observed in prior Zerenex studies, I'm skeptical Keryx can collate enough data to convince FDA -- and dialysis clinics, more importantly -- that there's compelling financial reasons to choose Zerenex over cheaper generic alternatives.

Johnnyboy writes: "Any clue why Sangamo Biosciences (SGMO) has doubled in the last couple of weeks on no news? I like the company and I think their technology is promising but pivotal results are months if not years away. Is this another case of stock pumping before they announce new financing?"

2 of 5

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs