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SOUTH SAN FRANCISCO - Allogene Therapeutics, Inc. (NASDAQ:ALLO), a biotechnology firm specializing in allogeneic CAR T therapies currently valued at approximately $299 million, has published new data from its Phase 1 ALPHA and ALPHA2 clinical trials. According to InvestingPro data, the company’s stock is trading near its 52-week low of $1.32, suggesting potential value opportunity for investors interested in the biotechnology sector. The studies, which investigated the efficacy of cemacabtagene ansegedleucel (cema-cel) in patients with relapsed/refractory large B-cell lymphoma (LBCL), showed comparable results to approved autologous CD19 CAR T treatments.
The data, featured in the Journal of Clinical Oncology, indicates an overall response rate of 58% and a complete response rate of 42% across the study. While the clinical results appear promising, InvestingPro analysis reveals the company maintains a strong current ratio of 9.35, with cash reserves exceeding debt obligations, providing financial flexibility to advance its clinical programs. With the pivotal study regimen, these rates improved to 67% and 58%, respectively. The median duration of response among patients who achieved complete response was 23.1 months, with median overall survival not yet reached.
The safety profile of cema-cel was manageable and consistent with approved autologous CD19 CAR T cell therapies. Notably, there were no instances of graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome, or high-grade cytokine release syndrome reported.
The treatment also demonstrated a quick turnaround, with a median time of two days from enrollment to treatment commencement, offering a significant advantage over the longer wait times typically associated with autologous CAR T cell products.
In addition, the study highlighted the potential benefits of cema-cel in patients with low disease burden. Among this subgroup, a complete response rate of 100% was achieved, supporting the use of cema-cel for patients with minimal residual disease (MRD).
These findings lay the groundwork for the ongoing ALPHA3 trial, which evaluates cema-cel as a consolidation therapy in LBCL patients who are in remission following first-line treatment but remain positive for MRD. This trial aims to intervene before relapse, potentially redefining the treatment paradigm for newly diagnosed patients.
Cema-cel has received Regenerative Medicine Advanced Therapy designation from the U.S. FDA for relapsed/refractory LBCL, with the ALPHA3 trial commencing in June 2024. Allogene holds rights to cema-cel in the U.S., EU, and UK, with options for rights in China and Japan.
This report is based on a press release statement from Allogene Therapeutics, Inc. Investors should note that the company’s next earnings report is scheduled for February 26, 2025. InvestingPro subscribers have access to 16 additional exclusive ProTips and comprehensive analysis, including detailed financial health scores and Fair Value estimates, helping investors make more informed decisions about biotechnology investments. The Pro Research Report available on InvestingPro provides deep-dive analysis of ALLO among 1,400+ top stocks.
In other recent news, Allogene Therapeutics has been in the spotlight with several significant developments. The company has announced the upcoming departure of executive officer Timothy Moore, with a consulting agreement in the works. The severance package, including cash compensation and COBRA reimbursement benefits, is contingent upon Moore providing a release and waiver of claims.
Simultaneously, Allogene has decided to halt new patient enrollment in the Phase 1 cohort of its ALPHA2 study, which is researching cema-cel for relapsed or refractory Chronic Lymphocytic Leukemia. This decision was influenced by slower-than-expected recruitment rates and the availability of new treatment alternatives. In response to this, Piper Sandler adjusted its financial outlook for Allogene, revising the stock’s price target down to $9 from the previous $11 but maintaining an Overweight rating.
These developments come as Allogene continues to focus on its core mission in the biotech industry. The company is expected to pursue a smooth transition following Moore’s departure and maintain its strategic direction in the biotechnology sector. It is noteworthy that these are recent developments, and the company’s next steps are anticipated with interest.
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