LOS ANGELES, CA / ACCESSWIRE / January 24, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Surmodics, Inc. ("Surmodics" or "the Company") (NASDAQ:SRDX) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Surmodics announced on January 19, 2023, that it had received a letter from the FDA related to its premarket approval (PMA) application for the SurVeilTM drug-coated balloon (DCB). The FDA indicated that the PMA could not be approved in its present form. The agency's letter stated that the Company must add information on biocompatibility and labeling via an amendment, among other items. In response to the FDA letter, the Company stated, "We are evaluating the issues raised in the FDA's letter and plan to meet with Agency representatives regarding its contents. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development." Based on this news, shares of Surmodics fell by more than 28.3% on the same day.
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The class in this case has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
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Brian Schall, Esq.
The Schall Law Firm
SOURCE: The Schall Law Firm