Breakthrough in CRISPR-Based Therapy: FDA Accepts Vertex and CRISPR Therapeutics' Exa-cel Application
Portfolio Pulse from Vandana Singh
The FDA has accepted Vertex Pharmaceuticals and CRISPR Therapeutics' exa-cel application for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT). Priority review has been granted for SCD, while standard review has been granted for TDT. Analysts maintain positive ratings on CRISPR Therapeutics.
June 09, 2023 | 6:08 pm
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NEUTRAL IMPACT
The standard review process for TDT could be due to the presence of an FDA-approved gene therapy for TDT from bluebird bio.
The standard review process for TDT in the exa-cel application may not have a significant impact on bluebird bio's stock price, as it is likely due to the presence of an existing FDA-approved gene therapy for TDT from the company. This suggests that the market for TDT treatments may already be competitive, and bluebird bio's position is not directly threatened by the exa-cel application.
CONFIDENCE 80
IMPORTANCE 40
RELEVANCE 50
POSITIVE IMPACT
FDA accepts CRISPR Therapeutics' exa-cel application for SCD and TDT, granting priority review for SCD. Analysts maintain positive ratings and increase price target.
The FDA's acceptance of CRISPR Therapeutics' exa-cel application for SCD and TDT is a major milestone for the company. The priority review for SCD and positive analyst ratings indicate a strong outlook for CRISPR Therapeutics, which could lead to increased stock price and growth.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
FDA accepts Vertex Pharmaceuticals' exa-cel application for SCD and TDT, granting priority review for SCD.
The FDA's acceptance of Vertex Pharmaceuticals' exa-cel application for SCD and TDT is a positive development for the company. The priority review for SCD indicates a faster approval process, which could lead to increased revenue and growth for Vertex.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80