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Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotech company currently trading at $1.17 per share, announced Friday that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen for its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL). According to InvestingPro analysis, the company maintains a strong liquidity position with a current ratio of 9.71, though it’s currently experiencing significant cash burn. The decision was made in collaboration with the ALPHA3 Data and Safety Monitoring Board, the study’s Steering Committee, and after consultation with the U.S. Food and Drug Administration.
The company reported that the arm of the study testing FC plus ALLO-647, an anti-CD52 monoclonal antibody, is now closed to further enrollment. This action was taken ahead of the scheduled futility analysis due to a Grade 5 adverse event in that arm. With a market capitalization of $258.1 million and holding more cash than debt on its balance sheet, the company appears positioned to navigate this clinical setback. For deeper insights into Allogene’s financial health and future prospects, InvestingPro subscribers have access to over 10 additional exclusive ProTips and comprehensive financial metrics. The event, which occurred on Day 54 post-infusion, involved hepatic failure attributed to disseminated adenovirus infection in the context of immune suppression. According to the company, the event was linked to the use of ALLO-647 and was deemed unrelated to cema-cel. Allogene stated that severe viral infections have been rare in its clinical trials, but when present, have been associated with immunosuppression from ALLO-647. No cases of adenoviral infection or hepatic failure have been observed in participants treated with FC lymphodepletion alone.
Following this protocol change, none of Allogene’s ongoing or planned trials will include ALLO-647. The company stated it will proceed with next-generation AlloCAR T product candidates using its proprietary Dagger Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion.
The amended ALPHA3 trial will now continue as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, which is the current standard of care. The statistical design and study conduct remain unchanged. The next milestone, a futility analysis comparing minimal residual disease conversion, is expected in the first half of 2026. With the stock down 18% in the past week and trading below its InvestingPro Fair Value, investors should note that 4 analysts have recently revised their earnings expectations upward for the upcoming period, suggesting potential optimism about the company’s strategic direction. Over 50 clinical sites in the United States and Canada are currently activated for the trial.
This information is based on a press release statement included in a filing with the Securities and Exchange Commission.
In other recent news, Allogene Therapeutics Inc . reported a net loss of $59.7 million for the first quarter of 2025, which equates to a loss of $0.28 per share. This result was in line with analysts’ expectations, who had projected a loss of $0.2864 per share. The company’s revenue forecast was set at $2.22 billion. In terms of analyst activity, Citizens JMP downgraded Allogene’s stock from Market Outperform to Market Perform following the release of the earnings report and corporate updates, citing delays in the ALPHA3 development timeline as a key factor. Meanwhile, both Citi and H.C. Wainwright maintained their Buy ratings on Allogene stock, with price targets of $4.00 and $8.00, respectively. These ratings were influenced by the company’s presentation of updated Phase 1b TRAVERSE data at the ASCO 2025 meeting. The data highlighted the efficacy of ALLO-316, a CD70-directed CAR-T therapy, in treating renal cell carcinoma. The presentation also emphasized the use of Allogene’s Dagger technology, which achieved a 31% confirmed overall response rate in heavily pretreated patients.
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