UMRX Plummets 23% on FDA Hold


Unum’s ($UMRX) already battered pharma stock was down 23% after hours last night, due to news of an FDA clinical hold on its ACTR087 treatment as a component for efficacy against non-Hodgkin’s lymphoma.

The basis for the FDA’s action illustrates some of the common dangers of chemotherapy drug combinations.

Reportedly, one patient included in a clinical trial suffered “serious neurotoxicity” and “life-threatening respiratory distress” from the treatment.

SeekingAlpha reports the clinical hold may not be as damaging to the company as it appears on its face, since UMRX has already pivoted to a different formulation referred to as ACTR707.

Internal fact sheets from Unum show how the new ACTR707 is being clinically developed, as well as how another product  is being researched for multiple myeloma:

“As a first-step, we are currently testing ACTR707 as a proof of concept in a Phase I multi-center open label clinical trial, ATTCK-20-03, in combination with rituximab, to enable rapid assessment of this alternative construct. We expect to leverage data from this Phase I clinical trial to inform future studies combining ACTR707 with a variety of antibodies targeting different cancers, including one combination, ACTR707 used in combination with trastuzumab, that we plan to evaluate for treatment of HER2+ cancers.”

The multiple product tracks will be good news for UMRX holders, since in addition to the fall from nearly $3.00 to $2.16 premarket, the stock has fallen from a high of $16 last August meaning that UMRX now stands at around one eighth of its maximum value overall.

Will news of future trials be enough to push the stock back up and garner investor interest? We’ll see. It might also be helpful to examine the context of some of the diseases that these products are meant to treat – for example, emerging non-Hodgkin’s lymphoma cases and their funding from Bayer/Monsanto settlements.

At the same time, it’s worth evaluating the current price point of UMRX in the context of its clinical trials and the industry as a whole.