After Miromatrix Medical (MIRO) announced the reception of the official clinical hold letter wherein the FDA requested additional non-clinical and clinical information and noted the response to the FDA would be made in the second half of this year, Piper Sandler analyst Matt O’Brien said announcement amounts to "what is ostensibly a 2 or 3-quarter delay for its miroliverELAP IND approval." While "disappointing," the delay "is not totally surprising as the technology [Miromatrix] is developing is sophisticated to say the least," the firm stated. In addition, Baxter (BAX) and Miromatrix announced a collaborative research agreement that the firm views as a reiteration of support despite the clinical hold. Piper, which remains "excited about the technology the company is developing," reiterates an Overweight rating and $9 price target on Miromatrix shares.
Published first on TheFly
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