That rolling review starts in November and covers the use of exa-cel in treating sickle cell disease and transfusion-dependent beta thalassemia (TDT). This comes after the treatment was awarded several major regulatory designations.
Crispr Therapeutics submitted exa-cel in collaboration with Vertex Pharmaceuticals (NASDAQ:VRTX). The company expects to complete the application for review by the end of the first quarter of 2023.
Nia Tatsis Ph.D., executive vice president, chief regulatory and quality officer at Vertex Pharmaceuticals, said the following about the rolling review:
“We are pleased to have concluded our exa-cel pre-submission meetings with regulators and are excited that FDA has granted a rolling review. We continue to work with urgency to bring forward the first CRISPR therapy for a genetic disease, and one that holds potential to transform the lives of patients with sickle cell disease or beta thalassemia.”
Other Plans for Exa-cel
To go along with this, Vertex Pharmaceuticals has completed discussions with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA). This has it expecting to submit that data by the end of the year.
CRSP stock is up 6.4% and CRTX stock is up 4.3% as of Tuesday morning.
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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.