This Day On The Street
Continue to site right-arrow
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: Exact Sciences, Galena, Titan, Arena, Breakthrough Therapy

Stocks in this article: EXAS GALE TTNP MNKD ARNA AMPE

Retail investors own the biggest slice of Galena so I expect the stock's rise and fall will correlate directly with the volume of published stories on sites like Seeking Alpha. If you're curious, I count 21 stories on Galena published by Seeking Alpha contributors since the beginning of the year -- almost all bullish, naturally. This trend will end badly for Galena bulls when the NeuVax phase III study fails.

One more note on Galena: The acquisition of U.S. marketing rights to Abstral, a sublingual fentanyl tablet for breakthrough cancer pain, was a dumb move. Abstral is no better than any of the cheap, generic fentanyl products available for use by doctors here. Galena not only went into debt to buy Abstral, but it will now waste even more money trying to sell the product -- unsuccessfully.

Tom B. asks, "What is your take on the FDA's breakthrough therapy designation?

I snarked on Twitter recently that this year's hottest FDA badge of honor -- breakthrough therapy -- was in danger of becoming as irrelevant as the now-derided fast-track status. I hope I'm wrong but the tangible benefits of breakthrough therapy status are unclear because FDA hasn't bothered to tell us what makes it so special. Right now, breakthrough designation is a shiny crown that drug companies want to wear. It elicits oohs and aahs from investors, but that's about it.

Here's how FDA describes breakthrough therapy designation:

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), as well as more intensive FDA guidance on an efficient drug development program. The FDA also has an organizational commitment to involve senior management in such guidance. 

"Preliminary clinical evidence" isn't defined, nor is "substantial improvement" but I guess it's like porn, you know it when you see it.

The two primary drug-review branches of FDA have received 50 applications for breakthrough therapy designation from July 2012 through March 31, 2013. Ten drugs were granted the designation, 12 were denied during this period. Presumably, the remaining applications are still under review.

Three breakthrough designations were awarded to the leukemia/lymphoma drug ibrutinib that's being developed by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ). Why the same drug requires three different breakthrough crowns is unclear. Other "winners" disclosed so far include Vertex Pharmaceuticals (VRTX), Pfizer (PFE) and Novartis (NVS).

I don't mean to be totally derisive of breakthrough therapy status. I'm just waiting to see if the new program actually accelerates drug development and approvals. Ibrutinib, for instance, is already in phase III studies, so how much will breakthrough status change timelines, compared to the "old" accelerated approval pathway? And if we rush drugs through shortened clinical trials based on preliminary data, will drug developers and FDA miss important safety findings?

3 of 5

Select the service that is right for you!

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!


DOW 18,030.21 +6.04 0.03%
S&P 500 2,081.88 -0.29 -0.01%
NASDAQ 4,773.4720 +8.0480 0.17%

Brokerage Partners

Rates from

  • 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