ImmunoGen Inc. (NASDAQ: IMGN) shares pushed higher to start out the week when the U.S. Food and Drug Administration (FDA) provided an update for the firm’s treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Specifically, the FDA granted a Breakthrough Therapy designation for IMGN632 for BPDCN. This designation was granted for IMGN632 based on the findings from the BPDCN cohort of the first-in-human study of IMGN632.
Initial data for IMGN632 was presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in 2019. Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH this December.
Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy.
Note that BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement and frequent spread to the bone marrow.
Management noted that it is looking forward to continuing to work with FDA to define further the development path for IMGN632 in BPDCN, in addition to pursuing its ongoing evaluation of IMGN632 in AML and other hematological malignancies.
Excluding Monday’s move, ImmunoGen stock had underperformed the broad markets with a retreat of 24% year to date. In the past 52 weeks, the share price was actually up about 63%.
ImmunoGen stock traded up about 5% on Monday, at $4.06 in a 52-week range of $1.95 to $7.07. The consensus price target is $7.96.