We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
CRISPR (CRSP) Rises More Than 40% in Past 3 Months: Here's Why
Read MoreHide Full Article
Shares of CRISPR Therapeutics AG (CRSP - Free Report) have rallied 41.9% in the past three months against the industry’s decline of 11.2%.
CRISPR Therapeutics has co-developed a CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel [exa-cel]), in partnership with Vertex Pharmaceuticals (VRTX - Free Report) , for treating two debilitating blood disorders, sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Earlier this month, the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom granted conditional marketing authorization to Casgevy for treating SCD and TDT.
Following the nod in the United Kingdom, Casgevy became the first CRISPR-based gene-editing therapy to get a regulatory authorization in the entire world.
Importantly, the approval made Casgevy the first approved product in CRISPR Therapeutics’ portfolio.
Image Source: Zacks Investment Research
We note that CRSP and VRTX’s biologics license applications (BLAs) seeking approval for exa-cel in SCD and TDT indications are currently under review in the United States.
The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication was accepted for a standard review. A final decision on the BLAs for exa-cel in SCD and TDT indications is expected by Dec 8, 2023 and Mar 30, 2024, respectively.
In October 2023, an FDA advisory committee appeared satisfied with CRISPR/Vertex’s regulatory filing on exa-cel in the SCD indication. This likely moves the gene therapy closer to gaining potential marketing approval from the agency.
Both the SCD and the TDT indications have a significant unmet medical need. A potential nod for exa-cel in the United States will be a major boost for CRISPR Therapeutics and is likely to drive the stock further in the future quarters.
This apart, CRISPR Therapeutics is also developing CRISPR candidates to create next-generation CAR-T cell therapies for treating hematological and solid-tumor cancers.
CTX110 is the company’s lead immune-oncology product candidate. A phase II study evaluating the consolidation dosing regimen of CTX110 is currently enrolling patients.
The company is also evaluating the safety and efficacy of CTX130 in two ongoing phase I studies for treating solid tumors such as renal cell carcinoma and certain T-cell and B-cell hematologic malignancies.
The company is developing two stem-cell therapy candidates targeting type I diabetes (T1D), along with partner ViaCyte (now acquired by Vertex).
Successful development of these candidates will be a significant boost for CRISPR Therapeutics.
However, stiff competition remains a headwind, as a few other companies are also using the CRISPR/Cas9 gene editing technology to address various ailments.
One such company is Editas Medicine (EDIT - Free Report) , which is developing its lead pipeline candidate EDIT-301, which employs CRISPR gene editing in a phase I/II study for SCD and TDT indications.
A prospective approval for the candidate developed by EDIT is likely to induce acute competition for CRISPR Therapeutics in the future.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 19.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
CRISPR (CRSP) Rises More Than 40% in Past 3 Months: Here's Why
Shares of CRISPR Therapeutics AG (CRSP - Free Report) have rallied 41.9% in the past three months against the industry’s decline of 11.2%.
CRISPR Therapeutics has co-developed a CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel [exa-cel]), in partnership with Vertex Pharmaceuticals (VRTX - Free Report) , for treating two debilitating blood disorders, sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Earlier this month, the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom granted conditional marketing authorization to Casgevy for treating SCD and TDT.
Following the nod in the United Kingdom, Casgevy became the first CRISPR-based gene-editing therapy to get a regulatory authorization in the entire world.
Importantly, the approval made Casgevy the first approved product in CRISPR Therapeutics’ portfolio.
We note that CRSP and VRTX’s biologics license applications (BLAs) seeking approval for exa-cel in SCD and TDT indications are currently under review in the United States.
The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication was accepted for a standard review. A final decision on the BLAs for exa-cel in SCD and TDT indications is expected by Dec 8, 2023 and Mar 30, 2024, respectively.
In October 2023, an FDA advisory committee appeared satisfied with CRISPR/Vertex’s regulatory filing on exa-cel in the SCD indication. This likely moves the gene therapy closer to gaining potential marketing approval from the agency.
Both the SCD and the TDT indications have a significant unmet medical need. A potential nod for exa-cel in the United States will be a major boost for CRISPR Therapeutics and is likely to drive the stock further in the future quarters.
This apart, CRISPR Therapeutics is also developing CRISPR candidates to create next-generation CAR-T cell therapies for treating hematological and solid-tumor cancers.
CTX110 is the company’s lead immune-oncology product candidate. A phase II study evaluating the consolidation dosing regimen of CTX110 is currently enrolling patients.
The company is also evaluating the safety and efficacy of CTX130 in two ongoing phase I studies for treating solid tumors such as renal cell carcinoma and certain T-cell and B-cell hematologic malignancies.
The company is developing two stem-cell therapy candidates targeting type I diabetes (T1D), along with partner ViaCyte (now acquired by Vertex).
Successful development of these candidates will be a significant boost for CRISPR Therapeutics.
However, stiff competition remains a headwind, as a few other companies are also using the CRISPR/Cas9 gene editing technology to address various ailments.
One such company is Editas Medicine (EDIT - Free Report) , which is developing its lead pipeline candidate EDIT-301, which employs CRISPR gene editing in a phase I/II study for SCD and TDT indications.
A prospective approval for the candidate developed by EDIT is likely to induce acute competition for CRISPR Therapeutics in the future.
CRISPR Therapeutics AG Price
CRISPR Therapeutics AG price | CRISPR Therapeutics AG Quote
Zacks Rank & Another Stock to Consider
CRISPR Therapeutics currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the biotech sector is CytomX Therapeutics, Inc. (CTMX - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 19.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.