) recently provided an update on its pipeline and maintained its
outlook for fiscal year 2013 (ending June 30) at its recently
held Analyst & Investor Day.
ImmunoGen stated that its primary focus will be on the
advancement of its pipeline. ImmunoGen currently has one approved
product along with three wholly owned clinical-stage compounds
and seven additional clinical-stage partner compounds.
ImmunoGen's Kadcyla (ado-trastuzumab emtansine or T-DM1) was
approved by the US Food and Drug Administration (FDA) for the
treatment of patients suffering from HER2-positive metastatic
breast cancer (mBC) in February this year.
The company is also expecting the EU approval of Kadcyla in
the second half of the calendar year 2013. We note that ImmunoGen
has partnered with
) for Kadcyla.
Pipeline in Focus
The company's three wholly owned clinical-stage compounds
include IMGN901, IMGN853 and IMGN529.
IMGN901 is currently in phase II development for the
first-line treatment of small-cell lung cancer (SCLC). With
patient enrolment being completed for the phase II study, the
company should be able to report results from a planned interim
analysis on progression free survival (PFS) in the second half of
2013. IMGN901 is also being developed for the treatment of
Moreover, ImmunoGen is developing IMGN853 in a phase I study
for the treatment of ovarian cancer, with initial data expected
in mid-2013. Another candidate, IMGN529 is also being developed
in a phase I clinical study for the treatment of non-Hodgkin's
lymphoma. The company expects clinical data from the study by
ImmunoGen plans to add IMGN289 to its pipeline this year. The
company intends to submit an Investigational New Drug (IND)
application for its EGFR-overexpressing solid tumors candidate,
IMGN289, in mid-2013. ImmunoGen expects to begin clinical testing
for the candidate by the end of 2013.
Fiscal 2013 Outlook Maintained
Apart from providing an update on its pipeline development
programs, ImmunoGen also maintained its guidance for fiscal 2013.
The company expects net loss of $70-$74 million for the fiscal
year 2013. ImmunoGen still expects to exit fiscal 2013 with cash
and cash equivalents of $172-$176 million.
We are positive on the FDA approval of Kadcyla since the
breast cancer market represents significant commercial potential.
We are also impressed by the company's efforts to develop its
Moreover ImmunoGen's alliances with big companies like Roche
) are also encouraging.
ImmunoGen, a biotech stock, presently carries a Zacks Rank #3
(Hold). Comparatively, other biotech stocks such as
) look better positioned. QLT currently carries a Zacks Rank #1
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