CVT in an Explanatory Mood

On Monday, Rule Breakers pick CV Therapeutics (Nasdaq: CVTX  ) presented preclinical data on its lead drug Ranexa at the American College of Cardiology (ACC) meeting.

Ranexa is already approved and marketed by CVT as a treatment for angina sufferers who are not responding to their current medications. CVT is also waiting to hear back from the FDA on its marketing applications to expand Ranexa's use into front-line angina, and for diabetics with coronary artery disease. The PDUFA review date for these two marketing applications is July 27, although it's anyone's guess whether the FDA can meet these review date goals. CVT suffered an FDA delay earlier this month with another drug.

The preclinical data on Ranexa that CVT announced on Monday was related to the drug's potential efficacy against type 2 diabetes, specifically Ranexa's ability to help control blood glucose levels. Although not a prerequisite for FDA approval, this information is important; the FDA also likes to understand how a drug works (its mechanism of action) when ruling on a compound. CVT surely hopes that the FDA will buy its argument and approve the new indication, so that it can compete -- in a limited subpopulation of diabetics -- against other diabetes treatments like GlaxoSmithKline's (NYSE: GSK  ) Avandia and Eli Lilly' (NYSE: LLY  ) and Amylin Pharmaceuticals' (Nasdaq: AMLN  ) Byetta.

The ACC meeting actually included nine presentations related to Ranexa. Investors interested in an overview can type in Ranexa's generic name (ranolazine) in the search field here to read them. CVT's choice to spotlight the preclinical mechanism of action data in an ACC press release, rather than providing clinical trial results, should assure investors that the company announced nothing dramatic at the conference. Nonetheless, the company's touting of Ranexa's potential benefits and past clinical trial successes will only help publicize its drug, and perhaps grow its sales from last year's $67 million.

Read/Post Comments (0) | Recommend This Article (3)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 613335, ~/Articles/ArticleHandler.aspx, 10/28/2016 6:20:52 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 9 hours ago Sponsored by:
DOW 18,169.68 -29.65 -0.16%
S&P 500 2,133.04 -6.39 -0.30%
NASD 5,215.97 -34.29 -0.65%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

4/17/2009 4:00 PM
CVTX.DL $20.01 Down +0.00 +0.00%
CV Therapeutics CAPS Rating: **
AMLN.DL $0.00 Down +0.00 +0.00%
Amylin Pharmaceuti… CAPS Rating: **
GSK $40.42 Up +0.08 +0.20%
GlaxoSmithKline CAPS Rating: ***
LLY $76.16 Down -0.60 -0.78%
Eli Lilly and Co. CAPS Rating: ***