This Day On The Street
Continue to site
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

Biotech Stock Mailbag: Keryx, Sangamo, Threshold and Amarin

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 <i>Hemodialysis International</i> 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 - Get Report) 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

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AMRN $1.85 0.00%
AEZS $4.13 1.70%
CELG $108.03 1.77%
KERX $5.26 3.54%
SGMO $6.30 -1.41%


Chart of I:DJI
DOW 17,830.76 -210.79 -1.17%
S&P 500 2,075.81 -19.34 -0.92%
NASDAQ 4,805.2910 -57.85 -1.19%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs