FDA Grants RMAT Designation to CRISPR’s CTX110

CRISPR Therapeutics’ (CRSP) CTX110, the allogeneic CAR-T cell therapy that targets CD19+ B-cell malignancies, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA).

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RMAT designation is a program designed to accelerate the drug development and review processes of promising pipeline products, including genetic therapies.

Shares of the biopharmaceutical company closed 2.2% lower on Monday.

CTX110 is undergoing the CARBON trial, which is designed to evaluate the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies. (See CRISPR stock charts on TipRanks)

CEO Comments

The CEO of CRISPR, Samarth Kulkarni, said, “This RMAT designation is based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative potential of CTX110 for the treatment of hematological malignancies. We look forward to working closely with the FDA as we continue our efforts to bring this important new therapeutic modality to patients.”

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Wall Street’s Take

On November 16, Chardan Capital analyst Geulah Livshits maintained a Buy rating with a price target of $171 (112.2% upside potential) on the stock.

The Street has a Strong Buy consensus rating based on 10 Buys versus 1 Hold. The average CRISPR price target stands at $157.30 and implies upside potential of 95.2% to current levels. Meanwhile, shares of the company have lost 26.7% over the past year.

Bloggers Weigh In

TipRanks data shows that financial blogger opinions are 86% Bullish on CRISPR, compared to a sector average of 68%.