ARIAD Pharmaceuticals, Inc.
) 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
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
) Sprycel (dasatinib) or
) 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.
ARIAD PHARMA (ARIA): Free Stock Analysis Report
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