Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



1 Biotech, 1 Week, 2 FDA Decisions

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

Regeneron Pharmaceuticals (Nasdaq: REGN  ) has two Food and Drug Administration decisions coming up this week.

Only one has a chance at resulting in an approval, though.

First the bad news: An FDA advisory panel unanimously recommended against expanding Arcalyst's indication to include the treatment of gout. Arcalyst is currently approved for treating cryopyrin-associated periodic syndromes, but those are ultra-orphan diseases that don't affect that many patients. In the second quarter, Arcalyst sales were just $6 million.

The biotech is expected to hear from the FDA today about the approval, but given the advisory committee's recommendation, I'd be shocked if the agency went against the strong recommendation and approved the expanded indication. Regeneron's management has basically conceded defeat, waiting for the FDA rejection so it has an outline of what's required before Arcalyst can be resubmitted. Given that the FDA's outside advisors were worried about the safety of the drug, there may be nothing that Regeneron can do but leave the gout market to Savient (Nasdaq: SVNT  ) , AstraZeneca (NYSE: AZN  ) , BioCryst Pharmaceuticals (Nasdaq: BCRX  ) and others developing gout treatments.

Regeneron's Zaltrap, which has a PDUFA date on Saturday, has a much better chance at an approval. The drug passed its phase 3 clinical trial in metastatic colon cancer, and side effects shouldn't be a problem given the life-threatening nature of colon cancer.

While an approval looks likely, it doesn't look like Zaltrap will be providing much to Regeneron's bottom line in the near future since the biotech got its partner Sanofi (NYSE: SNY  ) to pick up the development cost, but has to repay that before it can start reaping profits from the drug.

For now, Regeneron will have to rely on its macular degeneration drug, Eylea. Good thing the launch is going better than planned.

The biggest binary event, the presidential election, is around the corner. Check out the Fool's new free report, "These Stocks Could Skyrocket After the 2012 Presidential Election," where you'll get ideas for companies that can benefit from each candidate's platform. Get your free copy by clicking here.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

Read/Post Comments (0) | Recommend This Article (4)

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: 1964253, ~/Articles/ArticleHandler.aspx, 10/27/2016 10:48:28 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 Moments ago Sponsored by:
DOW 18,182.18 -17.15 -0.09%
S&P 500 2,135.68 -3.75 -0.18%
NASD 5,242.70 -7.57 -0.14%

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

10/27/2016 10:32 AM
REGN $367.45 Up +4.37 +1.20%
Regeneron Pharmace… CAPS Rating: ****
AZN $29.94 Up +0.35 +1.18%
AstraZeneca CAPS Rating: ****
BCRX $4.55 Down -0.03 -0.66%
BioCryst Pharmaceu… CAPS Rating: **
SNY $37.67 Up +0.61 +1.65%
Sanofi CAPS Rating: *****
SVNTQ $0.00 Down +0.00 +0.00%
Savient Pharmaceut… CAPS Rating: **