Shares of Crispr Therapeutics AG CRSP 6.36% fell more than 7 percent Thursday morning after the U.S. Food and Drug Administration said it placed a clinical hold on the company’s therapy.
What Happened
The FDA placed a clinical hold on the Investigational New Drug application for Crispr’s CTX001 for the treatment of sickle cell disease, Crispr and its partner Vertex Pharmaceuticals Incorporated VRTX 1.69% said in a press release. The hold is subject to the companies answering certain questions from the FDA as part of its review of the IND.
Why It’s Important
The details of the FDA’s hold are not revealed to the market, so the overall implications for Crispr aren’t fully known, Chardan’s Gbola Amusa said in a research report. Three outcomes are possible, the analyst said:
- A hold can be based on concerns over Crispr’s specificity or editing efficiency (overall sector risk).
- A hold can be based on an element of the CTX001 production or an aspect of the trial design (company-specific risk).
- A “rapid resolution” would help mitigate a negative impact on the CTX001 program and the gene editing space.
Chardan has a Buy rating on Crispr with a $72.50 price target.
What’s Next
Crispr and Vertex expect to receive additional information on the FDA’s list of questions in the “near future” and will “work rapidly” with the FDA toward a solution, the press release said.
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