SRDX - Surmodics stock surges 10% on FDA feedback for drug-coated balloon filing

2023-03-28 12:23:16 ET

Surmodics ( NASDAQ: SRDX ) stock rose ~10% on Tuesday after the company said it received positive feedback from the U.S. Food and Drug Administration (FDA) for its proposed approach to submit an amended premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).

In January, the FDA had declined to approve the SurVeil DCB which was followed by the company's announcement in February to cut its workforce by ~13%.

Surmodics had submitted a Submission Issue Request (SIR), under the FDA's Q-Submission program, to get a formal feedback from the agency.

The FDA requested additional clarification related to  completed biocompatibility studies and revisions to Surmodics' proposed labeling to amend the PMA application to put it into an approvable form.

"The feedback from the FDA provides the necessary clarity on the process and content required to successfully amend our PMA application. Importantly, we do not anticipate the need for additional biocompatibility studies, which will significantly reduce our initial assumptions of the time and cost to amend our PMA application," said Surmodics Gary Maharaj.

The company expects to file an amended PMA application in Q3 of its fiscal year 2023 and aims to get premarket approval in Q4, according to Maharaj.

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