Questions Surround Vertex/CRISPR's Sickle Cell Gene Therapy As FDA AdComm Meeting Approaches
Portfolio Pulse from Vandana Singh
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee is set to discuss Vertex Pharmaceuticals Inc (VRTX) and CRISPR Therapeutics AG's (CRSP) sickle cell disease gene therapy candidate. The FDA has raised questions about the sample size used by Vertex for its off-target editing analysis. The FDA decision date is set for 8 December. William Blair sees the situation as highly favorable for CRISPR/Vertex, but investors are concerned about whether the FDA will demand further analyses.
October 27, 2023 | 4:57 pm
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NEGATIVE IMPACT
The FDA's questions about the sample size used in the analysis of the gene therapy candidate could potentially impact CRISPR Therapeutics' stock.
The FDA's questions about the sample size used in the analysis of the gene therapy candidate could potentially delay the approval of the therapy, which could negatively impact CRISPR Therapeutics' stock.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 80
NEGATIVE IMPACT
The FDA's questions about the sample size used by Vertex for its off-target editing analysis could potentially impact the company's stock.
The FDA's questions about the sample size used by Vertex for its off-target editing analysis could potentially delay the approval of the therapy, which could negatively impact the company's stock.
CONFIDENCE 80
IMPORTANCE 70
RELEVANCE 80