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Allogene Therapeutics Inc (NASDAQ:ALLO) announced deprioritizing the currently enrolling third line Phase 2 ALPHA2 and EXPAND trials of cema-cel (ALLO-501A) and is now pursuing a potentially pivotal trial (ALPHA3) evaluating cema-cel as a consolidation therapy in large B-cell lymphoma (LBCL) patients in the first-line setting who are minimal residual disease positive (MRD+) following R-CHOP.
Start-up activities for the trial are already underway.
Allogene will initiate a new ALPHA2 cohort of 12 patients to evaluate cema-cel in patients with chronic lymphocytic leukemia (CLL) and will leverage currently active ALPHA2 U.S. trial sites to enroll patients. Enrolment will start in Q1 2024, with initial data expected by YE 2024.
Allogene anticipates that the company's cash runway will be sufficient to fund operations into 2026.
Allogene also announced expanding its pipeline into autoimmune diseases using ALLO-329, its next-gen CD19 CAR-T equipped with its Dagger technology. Initiation of the Phase I trial of ALLO-329 in autoimmune disease is expected in early 2025.
Concurrently, the company announced a partnership with Foresight Diagnostics to develop an MRD in-vitro diagnostic (IVD) that will be used to determine eligibility in the ALPHA3 trial.
William Blair writes that the company's recent business update marks a bold strategic move, potentially positioning it ahead of competitors in autologous and allogeneic CD19 CAR-T therapies. This decision might expand the company's potential market significantly.
Additionally, the analyst notes that allogeneic therapies have advantages, being more accessible than autologous products and more powerful than bi-specifics.
The expansion into Chronic Lymphocytic Leukemia (CLL) is a positive step, notes William Blair, showcasing Allogene's capability to effectively target indications suitable for allogeneic therapy.
The analyst reiterates the Outperform rating.
Price Action: ALLO shares are down 15.49% at $2.8650 on the last check Friday.
Posted In: ALLO
