ARIAD Pharmaceuticals, Inc.
) share price was up 2.37% after the company announced that
Iclusig was once again available in the U.S.
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We remind investors that the marketing and commercial
distribution of Iclusig in the U.S. was temporarily suspended in
Oct 2013 following instructions from the FDA due to a
higher-than-expected incidence of blood clots and narrowing of
The product now carries a revised label (indication) as well as a
boxed warning along with updated safety information and
recommendations regarding dosing. The label indicates that
Iclusig is approved for the treatment of T315I-positive chronic
myeloid leukemia (chronic phase, accelerated phase, or blast
phase) or T315I-positive Philadelphia chromosome positive (Ph+)
acute lymphoblastic leukemia, or chronic phase, accelerated
phase, or blast phase chronic myeloid leukemia or Ph+ acute
lymphoblastic leukemia in patients for whom no other
tyrosine-kinase inhibitor therapy is indicated.
Meanwhile, the starting dose remains unchanged at 45mg daily.
The resumption of marketing of Iclusig in the U.S. is a positive
development for ARIAD. ARIAD's shares have been on a
rollercoaster ride ever since news regarding safety issues
surrounding Iclusig first emerged. Now that Iclusig is back in
the market, we expect investor focus to remain on the product's
performance. Iclusig sales for the quarter ended Sep 30, 2013
were $16.7 million.
ARIAD carries a Zacks Rank #2 (Buy). Other players which look
attractive at current levels include
). While Endocyte and Grifols are Zacks Rank #1 (Strong Buy)
stocks, Biodel is a Zacks Rank #2 stock.