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!

Making The Call: Pharmacyclics FDA Drug Approval Before Year End

Stocks in this article: PCYC JNJ

^NBI Chart ^NBI data by YCharts

SUNNYVALE, Calif. ( TheStreet) -- Pharmacyclics' (PCYC) BTK inhibitor ibrutinib is an exceptionally effective drug for many B-cell cancers and will likely be approved and launched commercially well before most investors expect -- perhaps as early as the end of 2013.

An initial U.S. approval application for ibrutinib in relapsed/refractory mantle cell lymphoma (MCL) will be filed by the end of the third quarter, Pharmacyclics says. If FDA sticks to its typical eight-month review period, ibrutinib could be approved in the middle of 2014.

Ibrutinib, however, is not your typical cancer drug. FDA has already granted it three breakthrough therapy designations: relapsed/refractory MCL, Waldenstrom's Macroglobulinemia, and CLL/SLL for patients with deletion 17p. Ibrutinib will be the first breakthrough therapy to be reviewed by the FDA, so investors are watching closely to see what benefits (if any) Pharmacyclics receives for these designations.

Let's take a closer look at what the ibrutinib FDA review timeline might look like, and why I believe a December approval is possible:

We don't know the exact date Pharmacyclics and its partner Johnson & Johnson (JNJ) will submit ibrutinib to FDA. I'm going to assume September 1, since it fits the "before the end of the third quarter" guidance given by the two companies. If FDA went about the ibrutinib review in the usual manner, the approval would be announced on May 1, 2014. I'd be shocked if FDA took this much time.

More recently, FDA has been reviewing cancer drugs with alacrity. Ariad Pharmaceuticals' leukemia drug Iclusig was approved on Dec. 14, 2012 -- more than three months earlier than expected. Onyx Pharmaceuticals' multiple myeloma drug Kyprolis was approved one week early on July 20, 2012.

If ibrutinib gets an Iclusig-like review, the approval would come in February 2014.

A five-month review period would be nice, faster than normal, but would it be a prize big enough to justify the hoopla around FDA's breakthrough therapy designation? FDA created this new designation to "expedite the development and review of drugs for serious or life-threatening conditions." A five-month review hardly seems expeditious enough.

1 of 2

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