We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
ALLO Rises on Strong MRD Clearance With Cema-Cel in ALPHA3 Study
Read MoreHide Full Article
Key Takeaways
Allogene shares rose 12.5% after strong interim ALPHA3 data for cema-cel in first-line LBCL.
Cema-cel showed 58.3% MRD negativity versus 16.7% in the observation arm, a 41.6% improvement.
Cema-cel delivered 97.7% plasma ctDNA reduction with no serious adverse events reported.
Shares of Allogene Therapeutics (ALLO - Free Report) rose 12.5% on Monday after the company announced encouraging data from the planned interim futility analysis of the pivotal phase II ALPHA3 study, which evaluated its lead candidate, cema-cel, an off-the-shelf CAR T therapy, for treating first-line consolidation large B-cell lymphoma (LBCL).
Year to date, shares of Allogene have skyrocketed 123.3% compared with the industry’s rise of 0.6%.
Image Source: Zacks Investment Research
What Did the ALPHA3 Study Data Show?
At the planned data cutoff, triggered after the 24th patient completed day 45 minimal residual disease (MRD) assessment, treatment with cema-cel led to a higher MRD negativity (58.3%) than the observation arm (16.7%). This reflects a 41.6% absolute difference in MRD clearance between the two arms. MRD negativity is a strong predictor of relapse risk in LBCL.
Based on published literature, a 25-30% point improvement in MRD clearance may lead to meaningful clinical benefit at study completion.
Additionally, at the first MRD assessment (Day 45), treatment with cema-cel led to a 97.7% median reduction in plasma ctDNA levels, while the observation arm saw a 26.6% median increase.
Overall, the data showed that treatment with cema-cel led to a rapid, more effective and earlier reduction in MRD levels, the residual cancer that remains in the body after treatment, after first-line therapy.
Treatment with cema-cel was generally safe and well-tolerated at the data cutoff, with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease, or treatment-related serious adverse events reported.
How Does the Data Benefit ALLO?
Management noted that the above findings support cema-cel’s potential as a novel approach for high-risk LBCL patients following first-line treatment. Post-treatment MRD status is a strong predictor of relapse in LBCL, highlighting an opportunity for earlier intervention when disease burden is low but progression risk remains high.
Importantly, cema-cel demonstrated a favorable safety profile, with no treatment-related serious adverse events reported, and no cases of CRS or ICANS observed, supporting its potential for safe outpatient management.
Enrollment in the phase II ALPHA3 study is expected to be completed by the end of 2027.
The primary endpoint of the ALPHA3 study is event-free survival (EFS), along with key secondary endpoints of progression-free survival and overall survival, which remain blinded. The company plans an interim EFS analysis in mid-2027, followed by the primary EFS analysis in mid-2028. If successful, these data could support a biologics license application filing for cema-cel in LBCL.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87, while the same for 2027 have increased from $2.85 to $3.25. CPRX shares have gained 8.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08, while the same for 2027 have increased from $3.22 to $3.41. INDV shares have lost 11.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have rallied 32.1% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
ALLO Rises on Strong MRD Clearance With Cema-Cel in ALPHA3 Study
Key Takeaways
Shares of Allogene Therapeutics (ALLO - Free Report) rose 12.5% on Monday after the company announced encouraging data from the planned interim futility analysis of the pivotal phase II ALPHA3 study, which evaluated its lead candidate, cema-cel, an off-the-shelf CAR T therapy, for treating first-line consolidation large B-cell lymphoma (LBCL).
Year to date, shares of Allogene have skyrocketed 123.3% compared with the industry’s rise of 0.6%.
Image Source: Zacks Investment Research
What Did the ALPHA3 Study Data Show?
At the planned data cutoff, triggered after the 24th patient completed day 45 minimal residual disease (MRD) assessment, treatment with cema-cel led to a higher MRD negativity (58.3%) than the observation arm (16.7%). This reflects a 41.6% absolute difference in MRD clearance between the two arms. MRD negativity is a strong predictor of relapse risk in LBCL.
Based on published literature, a 25-30% point improvement in MRD clearance may lead to meaningful clinical benefit at study completion.
Additionally, at the first MRD assessment (Day 45), treatment with cema-cel led to a 97.7% median reduction in plasma ctDNA levels, while the observation arm saw a 26.6% median increase.
Overall, the data showed that treatment with cema-cel led to a rapid, more effective and earlier reduction in MRD levels, the residual cancer that remains in the body after treatment, after first-line therapy.
Treatment with cema-cel was generally safe and well-tolerated at the data cutoff, with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease, or treatment-related serious adverse events reported.
How Does the Data Benefit ALLO?
Management noted that the above findings support cema-cel’s potential as a novel approach for high-risk LBCL patients following first-line treatment. Post-treatment MRD status is a strong predictor of relapse in LBCL, highlighting an opportunity for earlier intervention when disease burden is low but progression risk remains high.
Importantly, cema-cel demonstrated a favorable safety profile, with no treatment-related serious adverse events reported, and no cases of CRS or ICANS observed, supporting its potential for safe outpatient management.
Enrollment in the phase II ALPHA3 study is expected to be completed by the end of 2027.
The primary endpoint of the ALPHA3 study is event-free survival (EFS), along with key secondary endpoints of progression-free survival and overall survival, which remain blinded. The company plans an interim EFS analysis in mid-2027, followed by the primary EFS analysis in mid-2028. If successful, these data could support a biologics license application filing for cema-cel in LBCL.
Allogene Therapeutics, Inc. Price
Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote
ALLO's Zacks Rank & Stocks to Consider
Allogene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Agenus (AGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87, while the same for 2027 have increased from $2.85 to $3.25. CPRX shares have gained 8.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08, while the same for 2027 have increased from $3.22 to $3.41. INDV shares have lost 11.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have rallied 32.1% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.