This Day On The Street
Continue to site
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

Biotech Stock Mailbag: Exact Sciences, Rexahn, Advaxis, Peregrine

NEW YORK (TheStreet) -- Welcome back to the Biotech Stock Mailbag. Let's get started with an email from Dapo A., who wants an update on Exact Sciences (EXAS - Get Report):

The next significant event for Exact Sciences should be publication of the Cologuard pivotal "Deep-C" validation study in a medical journal before the FDA advisory panel on March 27.

Exact Sciences announced top-line results from the Cologuard study last April, showing a 92% sensitivity to detect colon cancer and a 42% sensitivity for the detection of pre-cancerous lesions (the best and most important data from the study.) The specificity in the Deep-C trial was 87%.

We should get more details on Cologuard's stool-based colon-cancer screening performance from the journal publication, including specifics on the comparison to fecal immunochemical testing (FIT). Exact has already told investors Cologuard was superior to FIT for cancer and pre-cancer sensitivity, but we haven't seen the FIT sensitivity numbers yet.

On March 26, an FDA panel will review the blood-based mSEPT9 colon cancer screening test developed by Epigenomics. mSEPT9 is potential competition to Cologuard but sensitivity is weak -- 48% for cancer and 11% for (pre-cancerous) adenomas. mSEPT9 was most accurate in detecting stage IV colon cancer (77% sensitivity) but the benefit for patients is catching colon cancer early when it's most treatable, preferably when lesions are still pre-cancerous. The Epigenomics blood-based screen is convenient but doesn't appear to be particularly useful.

On March 27, the same FDA panel will review Cologuard. Unless there are major, hidden problems with the Deep-C data (I don't expect there will be), the panel should be uneventful and positive with a recommendation to approve Cologuard.

Two potential Cologuard controversies which may crop up at the March 27 panel: The appropriate testing interval, meaning how frequently should the Cologuard test be used. From a compliance and commercial standpoint, Exact Sciences would prefer a longer testing interval like once every three years. Anything shorter, like a recommendation that patients be screened every year, could be seen as a negative by investors.

The other potential hiccup would be pushback or criticism from the panel experts about the clinical significance of a 42% sensitivity for pre-cancerous lesions. The Cologuard detection rate for pre-cancerous lesions is superior to any currently available screening tests, but perhaps panel experts will find a nit to pick.

All in, I don't see a lot of downside risk in Exact Sciences going into publication of the Deep-C data or the FDA panel. (Knock on wood.) I also don't expect the stock to move significantly higher if the panel votes to recommend Cologuard's approval.

The bull-bear debate over Cologuard is focused -- appropriately -- on the commercial launch later this year. I'm an Exact Sciences bull and believe Cologuard will be a commercial success, but convincing people to poop in a bucket is going to be a challenge. Some investors are skeptical about Cologuard for this reason, understandably so. 

1 of 4

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
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
ADXS $22.75 0.00%
EXAS $26.55 0.00%
PPHM $1.30 0.00%
RNN $0.71 0.00%
AAPL $129.62 0.00%

Markets

DOW 18,041.54 -190.48 -1.04%
S&P 500 2,104.20 -21.86 -1.03%
NASDAQ 5,032.7510 -56.6110 -1.11%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs