Immunomedics indicated that it is now in broad alignment with the FDA around the issues raised in the Complete Response Letter and is projecting a biologics license application resubmission for sacituzumab to occur in early Q4, Piper Jaffray analyst Joseph Catanzaro tells investors in a post-earnings research note. The analyst believes this timeline is largely in-line with consensus and should provide a “bit of relief.” Investors may still have some questions around the Ascent trial timing, but given the FDA’s apparent comfort with the clinical data, a further approval delay is unlikely given the extreme unmet need in triple-negative breast cancer, adds the analyst. He maintains an Overweight rating on Immunomedics with a $20 price target.
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