By Colin Kellaher


Shares of Surmodics Inc. lost roughly a third of their value and hit a new 52-week low Thursday after the U.S. Food and Drug Administration turned away its application seeking approval of its SurVeil drug-coated balloon for a second time.

Surmodics, which had refiled its application in October with additional information requested by the FDA in 2021, said the agency once again determined that the application isn't currently approvable and is seeking more information on biocompatibility and labeling.

The Eden Prairie, Minn., company in November had said it was hoping to win FDA approval of the device by the end of March, which would have triggered a $27 million milestone payment from Abbott Laboratories under a 2018 commercialization agreement.

Surmodics said it plans to determine its path forward on SurVeil after meeting with the FDA to discuss the issues raised by the agency, and that it is looking at options to reduce its use of cash.

The company had been eligible for a $30 million payment from Abbott if the FDA had approved SurVeil by the end of 2022. The payment falls to $24 million if an FDA green light comes after June 30.

Surmodics won European approval of SurVeil for the treatment of peripheral artery disease in 2020.

Surmodics shares were recently changing hands at $24.94, down more than 33%, after hitting a 52-week low of $24.33 earlier in the session.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

01-19-23 1214ET