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CRISPR Therapeutics Trading Halted Today; FDA Advisory Committee to Review Biologics License Application (BLA) for Exagamglogene Autotemcel (exa-cel) in Sickle Cell Disease (SCD)

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CRISPR Therapeutics (Nasdaq: CRSP) announces trading halt as FDA reviews Biologics License Application for exagamglogene autotemcel (exa-cel) for sickle cell disease treatment.
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ZUG, Switzerland and BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that NASDAQ has halted trading of the Company’s common stock.

The U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee is meeting today to review the Biologics License Application (BLA) for exagamglogene autotemcel (exa-cel) for the treatment of sickle cell disease (SCD) in people ages 12 and older with recurrent vaso-occlusive crises.

The Advisory Committee meeting is scheduled for 9:00 AM ET. The briefing materials can be found on the FDA website HERE.

The Prescription Drug User Fee Act date for completion of the review of the BLA for exa-cel for SCD is December 8, 2023.

About CRISPR Therapeutics
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and cardiometabolic diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. For more information, please visit www.crisprtx.com.

CRISPR THERAPEUTICS® standard character mark and design logo are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

Investor Contact:
Susan Kim
+1-617-307-7503
susan.kim@crisprtx.com

Media Contact:
Rachel Eides
+1-617-315-4493
rachel.eides@crisprtx.com


FAQ

What is the company that made the announcement?

The company is CRISPR Therapeutics.

What is the stock symbol of CRISPR Therapeutics?

The stock symbol of CRISPR Therapeutics is CRSP.

What is the purpose of the Biologics License Application (BLA) being reviewed?

The BLA is being reviewed for exagamglogene autotemcel (exa-cel) for the treatment of sickle cell disease (SCD) in people ages 12 and older with recurrent vaso-occlusive crises.

What is the schedule for the Advisory Committee meeting?

The Advisory Committee meeting is scheduled for 9:00 AM ET.

When is the expected completion date for the review of the BLA?

The expected completion date for the review of the BLA is December 8, 2023.

CRISPR Therapeutics AG

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About CRSP

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit www.crisprtx.com.