ARIAD Pharmaceuticals, Inc. (ARIA - Free Report) recently completed the rolling submission of the New Drug Application (NDA) for its oncology candidate, ponatinib, to the US Food and Drug Administration (FDA). The rolling submission was completed with the submission of the rest of the chemistry, manufacturing, and controls (CMC) data.
Notably, in July this year, ARIAD initiated the rolling NDA submission for ponatinib. ARIAD is looking to get the candidate approved for use in adults suffering from resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
The company also requested the US regulatory body for accelerated approval and priority review of the ponatinib application. ARIAD expects ponatinib to be approved and launched in the US by the first quarter of next year.
Moreover, in August this year, ARIAD submitted a Marketing Authorization Application (MAA) for ponatinib, for the same indication, to the European Medicines Agency (EMA). ARIAD had requested accelerated assessment of the MAA for the candidate, which was granted by the Committee for Medicinal Products for Human Use (CHMP).
ARIAD also intends to commercialize ponatinib beyond Europe and the US. In August this year, the company initiated a multi-center phase I/II clinical trial with ponatinib in Japan, one of the largest CML markets in the world.
The Japanese trial is evaluating ponatinib in patients with CML who have failed treatment with Bristol-Myers Squibb Company’s (BMY - Free Report) Sprycel (dasatinib) or Novartis’ (NVS - Free Report) Tasigna (nilotinib) or with Ph+ ALL who have failed treatment with tyrosine kinase inhibitors.
We currently have a Neutral recommendation on ARIAD. The stock carries a Zacks #3 Rank (Hold rating) in the short run.