ImmunoGen (IMGN) Stock Climbs On Breakthrough Therapy Designation

ImmunoGen IMGN Stock News

ImmunoGen, Inc. (NASDAQ: IMGN) is running for the top in the market this morning, and for good reason. The company announced that it has been granted Breakthrough Therapy designation from the FDA. Here’s what’s going on:

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IMGN Stock Heads Up On Breakthrough Therapy Designation

In the press release, Immunogen said that the FDA has granted it Breakthrough Therapy designation for IMGN632. The designation was based on the candidate’s potential to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, or BPDCN.

This designation is big news for IMGN. After all, Breakthrough Therapy designation was designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary evidendce that the drug may demonstrate substantial imporvement over available therapy.

In the case of IMGN632, Breakthrough Therapy designation was based on the findings from the BPDCN cohort of the first in-human study of the treatment. This data was presented in an oral session at the American Society of Hematology Annual Meeting in 2019. Updated data from the treatment will be presented at the same annual meeting this year.

In a statement, Mark Enyedy, President and CEO at IMGN had the following to offer:

We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer. We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies.

This Is Big News

The news released by ImmunoGen early this morning proved to be overwhelmingly positive. First and foremost, the Breakthrough Therapy designation serves to validate the fact that the company’s headed in the right direction with this treatment. After all, there has to be evidence of efficacy in order to qualify for the designation.

Furthermore, the designation will provide the company with key perks that will provide assistance throughout the development process and potentially reduce the time to potential approval. All in all, the Breakthrough Therapy designation is great news and IMGN stock is one to watch closely.

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