Surmodics Shares Rise 11% After FDA Request for SurVeil Drug-Coated Balloon Info

By Chris Wack

Surmodics Inc. shares were up 11% at $21.34 after the company said Tuesday it has received formal feedback from the U.S. Food and Drug Administration related to its proposed approach to submit an amended premarket approval application for the SurVeil drug-coated balloon.

The stock hit its 52-week low of $16 on March 20, and is down 50% in the past 12 months.

Following the receipt of the FDA letter in January, Surmodics said it has been focused on obtaining additional clarification and feedback on the pathway and requirements to submit an amended premarket approval application for the SurVeil DCB in an approvable form.

Surmodics prepared and submitted a Submission Issue Request, under the FDA's Q-Submission Program, to obtain the agency's formal feedback on its proposed approach for addressing the FDA letter. The company has received written feedback from the FDA in response to its Submission Issue Request and completed a Submission Issue Meeting to discuss the request and this written feedback.

In its verbal and written feedback, the FDA requested additional clarification related to already completed biocompatibility studies and revisions to the company's proposed labeling to amend the PMA application to put it into an approvable form.

The company said it is preparing an amended PMA application for submission in the third quarter of fiscal 2023, with a target of receiving premarket approval in the fourth quarter.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 28, 2023 12:53 ET (16:53 GMT)

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