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CRISPR (CRSP) Shares Rise 24% in the Last Quarter: Here's Why
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In the last quarter, shares of CRISPR Therapeutics (CRSP - Free Report) have gained 24.1% against the industry’s 3.4% fall.
Image Source: Zacks Investment Research
The steep rise in the stock price can be associated with the completion of the biologics license applications (BLAs) to the FDA for exagamglogene autotemcel (exa-cel) and its subsequent acceptance to treat sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT) by CRISPR and partner, Vertex Pharmaceuticals (VRTX - Free Report) .
The companies started the BLA submission in November 2022 and announced completing the same in April 2023. Notably, if exa-cel is approved in Europe or the United States, it will trigger a $200 million milestone payment which we expect the company to receive in the fourth quarter of 2023.
CRISPR is rapidly leveraging its CRISPR/Cas9 gene-editing platform to make therapies for the treatment of hemoglobinopathies, cancer, diabetes and other diseases. Currently, it has no marketed drug in its portfolio. Its lead pipeline candidate is exa-cel.
Exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy, developed to treat SCD or TDT. The completion of the BLA filing for exa-cel is a milestone as it is the first regulatory filing for a CRISPR-based treatment within a decade of the CRISPR platform’s discovery.
In June 2023, CRSP and VRTX announced that the FDA has accepted its BLAs for exa-cel to treat SCD and TDT. Furthermore, The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication has been accepted for a standard review by the agency. Final decisions on the BLAs for exa-cel in SCD and TDT indications are expected by Dec 8, 2023 and Mar 30, 2024, respectively.
Unlike standard reviews that require a time of 12 months for completion, priority reviews shorten the FDA's review timeline to eight months.
The BLA submission is supported by data from the ongoing phase III studies, CLIMB-111 and CLIMB-121, and an ongoing long-term follow-up study, CLIMB-131.
Both SCD and TDT have significant unmet medical needs and if successfully developed and commercialized, exa-cel can provide a huge boost to CRISPR Therapeutics’ prospects. The company, along with Vertex, has also initiated two new phase III studies evaluating exa-cel in pediatric patients with TDT and SCD.
Vertex and CRISPR also filed similar submissions on exa-cel in Europe and the U.K. in December 2022 that were validated by the respective regulatory authorities in January 2023.
Apart from exa-cel, ViaCyte (now acquired by Vertex) and CRISPR are developing stem-cell therapies for diabetes. VRTX is currently enrolling study participants in a phase I/II study evaluating VCTX211, a stem-derived candidate for type I diabetes indication. This March, Vertex signed another agreement with CRSP to accelerate the development of the former’s hypoimmune cell therapies for type I diabetes.
Besides its collaboration with Vertex, the company is also developing two gene-edited allogeneic CAR-T cell therapy candidates, CTX110 and CTX130, targeting hematological and solid tumor cancers in separate early-to-mid-stage studies. In May 2023, CRISPR announced that it has started separate phase I/II studies on new CAR-T candidates, which are CTX112 (targeting CD19-positive B-cell malignancies) and CTX131 (targeting relapsed or refractory solid tumors).
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 14 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. In the last quarter, shares of ADMA have gained 11.5%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.92 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.31 to $3.27. In the last quarter, shares of AKRO have gained 22%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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CRISPR (CRSP) Shares Rise 24% in the Last Quarter: Here's Why
In the last quarter, shares of CRISPR Therapeutics (CRSP - Free Report) have gained 24.1% against the industry’s 3.4% fall.
Image Source: Zacks Investment Research
The steep rise in the stock price can be associated with the completion of the biologics license applications (BLAs) to the FDA for exagamglogene autotemcel (exa-cel) and its subsequent acceptance to treat sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT) by CRISPR and partner, Vertex Pharmaceuticals (VRTX - Free Report) .
The companies started the BLA submission in November 2022 and announced completing the same in April 2023. Notably, if exa-cel is approved in Europe or the United States, it will trigger a $200 million milestone payment which we expect the company to receive in the fourth quarter of 2023.
CRISPR is rapidly leveraging its CRISPR/Cas9 gene-editing platform to make therapies for the treatment of hemoglobinopathies, cancer, diabetes and other diseases. Currently, it has no marketed drug in its portfolio. Its lead pipeline candidate is exa-cel.
Exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy, developed to treat SCD or TDT. The completion of the BLA filing for exa-cel is a milestone as it is the first regulatory filing for a CRISPR-based treatment within a decade of the CRISPR platform’s discovery.
In June 2023, CRSP and VRTX announced that the FDA has accepted its BLAs for exa-cel to treat SCD and TDT. Furthermore, The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication has been accepted for a standard review by the agency. Final decisions on the BLAs for exa-cel in SCD and TDT indications are expected by Dec 8, 2023 and Mar 30, 2024, respectively.
Unlike standard reviews that require a time of 12 months for completion, priority reviews shorten the FDA's review timeline to eight months.
The BLA submission is supported by data from the ongoing phase III studies, CLIMB-111 and CLIMB-121, and an ongoing long-term follow-up study, CLIMB-131.
Both SCD and TDT have significant unmet medical needs and if successfully developed and commercialized, exa-cel can provide a huge boost to CRISPR Therapeutics’ prospects. The company, along with Vertex, has also initiated two new phase III studies evaluating exa-cel in pediatric patients with TDT and SCD.
Vertex and CRISPR also filed similar submissions on exa-cel in Europe and the U.K. in December 2022 that were validated by the respective regulatory authorities in January 2023.
Apart from exa-cel, ViaCyte (now acquired by Vertex) and CRISPR are developing stem-cell therapies for diabetes. VRTX is currently enrolling study participants in a phase I/II study evaluating VCTX211, a stem-derived candidate for type I diabetes indication. This March, Vertex signed another agreement with CRSP to accelerate the development of the former’s hypoimmune cell therapies for type I diabetes.
Besides its collaboration with Vertex, the company is also developing two gene-edited allogeneic CAR-T cell therapy candidates, CTX110 and CTX130, targeting hematological and solid tumor cancers in separate early-to-mid-stage studies. In May 2023, CRISPR announced that it has started separate phase I/II studies on new CAR-T candidates, which are CTX112 (targeting CD19-positive B-cell malignancies) and CTX131 (targeting relapsed or refractory solid tumors).
CRISPR Therapeutics AG Price and Consensus
CRISPR Therapeutics AG price-consensus-chart | CRISPR Therapeutics AG Quote
Zacks Rank and Stocks to Consider
CRISPR currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ADMA Biologics, Inc. (ADMA - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 14 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. In the last quarter, shares of ADMA have gained 11.5%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.92 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.31 to $3.27. In the last quarter, shares of AKRO have gained 22%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.