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As evidenced by the volume of shares traded, IMGN still has not caught the fancy of investors or traders of substance. IMGN has moved up smartly from month ago lows of 4 dollars and is now trading in the $7 range. The volume remains around one-half million shares per day, with no major high volume days. Buyers seem content to add a few blocks of stock per day, as the stock price climbs 20-30 cents a day for a few days, then retreat for a day or so, then resume.
One would ask, "why is the stock moving?" Well, Genentech (DNA), which has collaborated with IMGN to produce future blockbuster drug TDM1 announced the beginning of a Pivotal phase 3 trial for second-line treatment of metastatic breast cancer (MBC). This news was highly anticipated, yet a welcome relief to shareholders who wondered aloud, "what's taking so long?" But the real news on the TDM1 front is not the pivotal phase 3 trial, but rather the phase 2 trial which just recently completed enrollment for third-line treatment of MBC. It's given after patients have already failed, second line treatment (Tykerb + Xeloda).
Data announced at the SABC in December 2008 blew away investigators with response rates,CRs / PRs over 40% in the patient population that already failed second line treatment (Tykerb + Xeloda). It left investors wondering why the drug is not already approved. Well, that day is coming.
Genentech announced that the final patients of the phase 2 trial in third line treatment will dosed before the end of March 2009. Data will be compiled, and investors expect Genentech to file for approval of TDM1 in the third line setting at the end of calendar 2009 or early Q1, 2010, with approval expected in late Q3 of 2010.
Here is a link to comments made by Dr Burris, regarding TDM1 from the SABC. Enlightening does not come close to describing his feelings about the future of TDM1.
Disclosure: Long IMGN.
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