NEW YORK, NY / ACCESSWIRE / February 8, 2023 / Pomerantz LLP is investigating claims on behalf of investors of Miromatrix Medical Inc. ("Miromatrix" or the "Company") (NASDAQ:MIRO). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.
The investigation concerns whether Miromatirx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
After the market closed on December 14, 2022, Miromatrix issued a press release announcing that the U.S. Food & Drug Administration ("FDA") placed a clinical hold on the Company's Investigational New Drug application for its product miroliverELAP the treatment of acute liver failure. The press release further provided that the FDA would provide an official clinical hold letter to Miromatrix within 30 days.
On this news, Miromatrix's share price fell $1.24 per share, or 30.24%, to close at $2.86 per share on December 15, 2022.
Then, on February 1, 2022, Miromatrix issued a press release announcing that "[i]n January 2023, Miromatrix received the formal clinical hold letter from the FDA detailing the specific items to be addressed in the IND submission and the information needed to resolve them. In the letter, the FDA requested additional non-clinical and clinical information. The information provided by the FDA also provides valuable insights relating to certain chemistry, manufacturing and control (CMC) and clinical protocol topics unrelated to the clinical hold."
On this news, Miromatrix's stock price fell $0.36 per share, or 10.32%, to close at $3.13 per share on February 1, 2023.
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SOURCE: Pomerantz LLP