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) to Focus on Next-Generation CAR T Pipeline
Read MoreHide Full Article
CRISPR Therapeutics (CRSP - Free Report) announced new updates on its immuno-oncology pipeline, focused on developing CRISPR/Cas9 gene-edited allogeneic CAR T cell product candidates.
CRSP announced its decision to discontinue the development of first-generation allogeneic CAR T product candidates, CTX110 (targeting CD19) and CTX130 (targeting CD70). Management will focus on developing their respective next-generation CAR T candidates, CTX112 and CTX131. As part of this decision, it will transition patients treated with first-generation candidates to long-term follow-up programs where needed.
This decision is based on preliminary data from ongoing early-stage clinical studies, which suggest that CTX112 and CTX131 have the potential to improve upon the clinical profile observed with CTX110 and CTX130, respectively.
Per management, the gene-edits made for next-generation candidates lead to significantly higher CAR T cell expansion and functional persistence in patients compared with the first-generation candidates. Also, CTX112 and CTX131 have demonstrated increased manufacturing robustness, with a higher and more consistent number of CAR T cells produced per batch.
In May 2023, management announced that it had started separate phase I/II studies on CTX112 (targeting CD19-positive B-cell malignancies) and CTX131 (targeting relapsed or refractory solid tumors). These candidates have demonstrated the potential to enhance CAR-T potency and reduce CAR T exhaustion.
CRISPR Therapeutics also announced its plans to expand the next-generation candidates beyond immune-oncology indications. The company intends to expand CTX112 into autoimmune indications. In this regard, management intends to start a clinical study evaluating CTX112 in systemic lupus erythematosus (SLE) indication by first-half 2024.
Year to date, shares of CRISPR Therapeutics have surged 75.9% against the industry’s 21.2% decline.
Image Source: Zacks Investment Research
Prior to the discontinuation decision, CRISPR was developing CTX110 and CTX130 in separate clinical studies for hematological and solid-tumor cancers. A phase II study evaluating the consolidation dosing regimen of CTX110 was enrolling patients. The company was also evaluating the safety and efficacy of CTX130 in two ongoing early-stage studies for treating solid tumors such as renal cell carcinoma and certain T-cell and B-cell hematologic malignancies.
Management claims that the ongoing studies on CTX110 and CTX130 have provided important proof of concept that allogeneic CAR T cells can produce durable remissions following a standard lymphodepletion regimen.
These updates just come a few days prior to the FDA’s final decision on CRISPR Therapeutics’ regulatory filing on the CRISPR/Cas9 gene-edited therapy exa-cel to treat sickle cell disease (SCD). A final decision is expected by Dec 8, 2023. The company also submitted a regulatory filing with the agency for exa-cel in transfusion-dependent beta thalassemia (TDT), whose decision is expected by Mar 30, 2024.
Exa-cel has been developed by CRSP in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) . Earlier this month, the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the U.K. granted conditional marketing authorization to exa-cel for treating SCD and TDT indications. CRISPR and Vertex will market exa-cel in the U.K. under the trade name Casgevy.
Following the U.K. authorization, the CRISPR/Vertex partnered therapy became the first CRISPR-based gene-editing therapy to get regulatory approval in the world. CRISPR and Vertex have also filed similar regulatory submissions for exa-cel in the European Union, which were validated in January.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 10.0% in the year-to-date period.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share (EPS) have increased from $2.19 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.54 to $3.07. Shares of NVO have surged 49.1% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
CRISPR (CRSP) to Focus on Next-Generation CAR T Pipeline
CRISPR Therapeutics (CRSP - Free Report) announced new updates on its immuno-oncology pipeline, focused on developing CRISPR/Cas9 gene-edited allogeneic CAR T cell product candidates.
CRSP announced its decision to discontinue the development of first-generation allogeneic CAR T product candidates, CTX110 (targeting CD19) and CTX130 (targeting CD70). Management will focus on developing their respective next-generation CAR T candidates, CTX112 and CTX131. As part of this decision, it will transition patients treated with first-generation candidates to long-term follow-up programs where needed.
This decision is based on preliminary data from ongoing early-stage clinical studies, which suggest that CTX112 and CTX131 have the potential to improve upon the clinical profile observed with CTX110 and CTX130, respectively.
Per management, the gene-edits made for next-generation candidates lead to significantly higher CAR T cell expansion and functional persistence in patients compared with the first-generation candidates. Also, CTX112 and CTX131 have demonstrated increased manufacturing robustness, with a higher and more consistent number of CAR T cells produced per batch.
In May 2023, management announced that it had started separate phase I/II studies on CTX112 (targeting CD19-positive B-cell malignancies) and CTX131 (targeting relapsed or refractory solid tumors). These candidates have demonstrated the potential to enhance CAR-T potency and reduce CAR T exhaustion.
CRISPR Therapeutics also announced its plans to expand the next-generation candidates beyond immune-oncology indications. The company intends to expand CTX112 into autoimmune indications. In this regard, management intends to start a clinical study evaluating CTX112 in systemic lupus erythematosus (SLE) indication by first-half 2024.
Year to date, shares of CRISPR Therapeutics have surged 75.9% against the industry’s 21.2% decline.
Image Source: Zacks Investment Research
Prior to the discontinuation decision, CRISPR was developing CTX110 and CTX130 in separate clinical studies for hematological and solid-tumor cancers. A phase II study evaluating the consolidation dosing regimen of CTX110 was enrolling patients. The company was also evaluating the safety and efficacy of CTX130 in two ongoing early-stage studies for treating solid tumors such as renal cell carcinoma and certain T-cell and B-cell hematologic malignancies.
Management claims that the ongoing studies on CTX110 and CTX130 have provided important proof of concept that allogeneic CAR T cells can produce durable remissions following a standard lymphodepletion regimen.
These updates just come a few days prior to the FDA’s final decision on CRISPR Therapeutics’ regulatory filing on the CRISPR/Cas9 gene-edited therapy exa-cel to treat sickle cell disease (SCD). A final decision is expected by Dec 8, 2023. The company also submitted a regulatory filing with the agency for exa-cel in transfusion-dependent beta thalassemia (TDT), whose decision is expected by Mar 30, 2024.
Exa-cel has been developed by CRSP in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) . Earlier this month, the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the U.K. granted conditional marketing authorization to exa-cel for treating SCD and TDT indications. CRISPR and Vertex will market exa-cel in the U.K. under the trade name Casgevy.
Following the U.K. authorization, the CRISPR/Vertex partnered therapy became the first CRISPR-based gene-editing therapy to get regulatory approval in the world. CRISPR and Vertex have also filed similar regulatory submissions for exa-cel in the European Union, which were validated in January.
CRISPR Therapeutics AG Price
CRISPR Therapeutics AG price | CRISPR Therapeutics AG Quote
Zacks Rank & Other Key Picks
CRISPR Therapeutics currently carries a Zacks Rank #2 (Buy). Another couple of top-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) and Novo Nordisk (NVO - Free Report) , each 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 improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 10.0% in the year-to-date period.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share (EPS) have increased from $2.19 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.54 to $3.07. Shares of NVO have surged 49.1% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.