H.C. Wainwright sees no further delay after Krystal’s B-VEC PDUFA date revision

H.C. Wainwright analyst Joseph Pantginis notes Krystal announced that based on manufacturing information recently submitted to the FDA in response to an information request, the agency has revised the PDUFA date for the B-VEC application to May 19, 2023, with labeling discussions anticipated no later than April 20, 2023. Specifically, per company management, the additional manufacturing information submitted described a replaced hardware unit in the concentration step of the manufacturing process and comparability data supporting the use of the unit which, importantly, did not affect any processing parameters. Pantginis highlights that although this is not a desirable revision in timeline, the basis for the change should be viewed as a non-issue moving forward, as the amendment is not data-related. The analyst has a Buy rating on the shares with a price target of $119.