Back to top

Analyst Blog

Raptor Pharmaceutical Corp. (RPTP - Snapshot Report) recently announced that the US Food and Drug Administration (FDA) has extended the review period for its candidate, RP103 (proposed brand name: Procysbi). The FDA’s final decision is now expected by April 30, 2013 instead of January 30, 2013. Raptor Pharma is looking to get RP103 approved for the treatment of nephropathic cystinosis.

The company noted that the FDA has not asked for any additional studies of RP103 and has extended the review period to review the additional data submitted after October 30, 2012.

We note that the company is also seeking approval of RP103 for nephropathic cystinosis in the EU and has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the same. A final decision from the EMA is expected in the first half of 2013.

Raptor Pharma is also developing the candidate for other indications including Huntington's disease. A randomized, controlled, double-blind multicenter phase II/III trial evaluating RP103 for the treatment of Huntington’s disease patients with cysteamine is ongoing. The company has received orphan drug designation from the FDA for RP103 for the Huntington’s disease indication.

The company’s pipeline also includes RP104, a delayed-release tablet form of RP103, which is being developed for non-alcoholic steatohepatitis (NASH). Currently, the candidate is being evaluated in a randomized, multicenter, double-blind, placebo-controlled phase IIb trial for reversal damage caused by NASH in children.

We currently have a Neutral recommendation on Raptor Pharma. The stock carries a Zacks #3 Rank (Hold) in the short run.

Pharma stocks that currently look more attractive include companies like Sanofi (SNY - Analyst Report), AstraZeneca (AZN - Analyst Report) and Novo Nordisk (NVO - Analyst Report). All these companies carries a Zacks #2 Rank (Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
CENTURY ALU… CENX 22.53 +4.50%
ERBA DIAGNO… ERB 2.91 +4.30%
PLANAR SYST… PLNR 4.31 +3.86%
MALLINCKROD… MNK 72.17 +3.83%
GTT COMMUNI… GTT 12.06 +3.52%