CP101 is Finch Therapeutics’s investigational new drug designed to prevent recurrent C. difficile infection. The clinical hold was on the company’s application for this drug. This will allow it to move forward with a Phase 3 clinical trial of the treatment.
So what’s behind the end of the clinical hold on CP101? The FDA released its hold on the drug after a review from Finch Therapeutics. That covered its SARS-CoV-2 screening procedures, as well as associated informed consent language.
According to Finch Therapeutics, it will move forward with its PRISM4 clinical trial after completing requirements in manufacturing and quality connected to the FDA hold. The company intends to update shareholders when it has the timing for the clinical trial down.
Mark Smith, PhD, CEO of Finch Therapeutics, said the following in the press release sending FNCH stock higher.
“We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
It’s worth pointing out that the rally of FNCH stock today comes after almost of week of retreats. That was tied to the company cutting 20% of its workforce and shifting focus to different medicines.
FNCH stock is up 32.8% as of Friday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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