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This Stock Rocks as Its Drug Rolls Ahead

Keith Speights
September 28, 2012

Check another item off the list for ARIAD Pharmaceuticals (Nasdaq: ARIA  ) as it rolls along with its plans for ponatinib. The company announced on Thursday that it completed the rolling submission of the New Drug Application for ponatinib. ARIAD has requested accelerated approval and a priority review from the Food and Drug Administration.

What it means
The FDA allows rolling submissions of NDAs only for drugs that have received fast-track designation. The process enables drug companies to file sections of the NDA for the FDA to review prior to the entire NDA being completed. 

ARIAD submitted most sections of the NDA for ponatinib in July. The final submission that was just announced included remaining chemistry, manufacturing, and controls data.

Shares immediately received a bump upwards on the news of the final submission. Not that much of a bump was needed. The stock continues to perform like a rock star for shareholders, shooting up more than 130% in the past year.

The market appears to have baked ultimate FDA approval for ponatinib into the stock price. So far, no reasons have emerged to doubt that approval will be given.

Looking ahead
ARIAD certainly looks like a winner right now, with the stock rocking and the approval process for ponatinib rolling along in the U.S. and Europe. The company's pipeline also includes several other promising drugs.

The product farthest along in the development