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.
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 cycle is ridaforolimus, a cancer drug developed by ARIAD and licensed to Merck (MRK 1.43%). Merck filed for approval of the drug in the U.S. and Europe in the third quarter of 2011. In June of this year, the FDA responded that initial clinical trials would be needed.
Obstacles to ARIAD's success do exist, though. Other drugs already have a share of the chronic myelogenous leukemia market.
Novartis (NVS 1.85%) makes both Gleevec and Tasigna. Bristol-Myers Squibb (BMY 1.51%) markets Sprycel for patients who cannot take Gleevec. Pfizer (PFE 0.89%) received approval for Bosutinib earlier this year.
While most investors seem to view ARIAD quite optimistically, some wonder how much more its shares can rise. Fellow Fool Sean Williams recently discussed his reasons for being pessimistic about ARIAD. Potential investors would be wise to look at both bull and bear arguments.
My take is that ARIAD should continue to perform well for at least the next several months. At some point, the market might realize that share prices have outpaced the actual revenue potential for ponatinib. In the meantime, ARIAD investors know that the stock rocks and the approval process rolls -- and they like it.