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SOUTH SAN FRANCISCO - Allogene Therapeutics, Inc. (NASDAQ: ALLO), a $313 million market cap biotechnology firm focusing on allogeneic CAR T therapies, announced today that its investigational CAR T product, ALLO-329, has been granted three Fast Track Designations by the U.S. Food and Drug Administration (FDA). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 8.54, though it’s currently operating at a loss. These designations are for the treatment of adult patients with certain severe autoimmune diseases, including systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).
The Fast Track Designations aim to expedite the development and review process of drugs that target serious conditions and fulfill unmet medical needs. ALLO-329 is engineered to target both CD19+ B cells and CD70+ T cells, which are implicated in the pathogenesis of autoimmune diseases. With the company’s next earnings report due on April 30, 2025, InvestingPro analysis shows that three analysts have revised their earnings upwards for the upcoming period, suggesting growing confidence in the company’s prospects. The company’s Dagger® technology, which is part of ALLO-329’s design, could potentially reduce or eliminate the need for lymphodepletion—a pre-treatment that can be a significant barrier to CAR T cell therapy in autoimmune diseases.
Allogene plans to initiate the Phase 1 RESOLUTION trial in mid-2025. This trial will assess the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc. The trial will include two lymphodepletion arms, one with cyclophosphamide alone and another without lymphodepletion. Proof-of-concept results are expected by the end of 2025.
ALLO-329 employs CRISPR-based site-specific integration for dual CAR expression, which may enhance therapeutic benefits across a range of autoimmune indications. The product candidate’s development reflects Allogene’s broader goal of delivering scalable, off-the-shelf CAR T cell therapies to a wider patient population.
The Fast Track Designations for ALLO-329 underscore the potential of this investigational product to transform the treatment landscape for autoimmune diseases. However, it’s important to note that such designations do not guarantee future approval or commercial success and can be revoked if the product no longer meets the necessary criteria.
This news is based on a press release statement from Allogene Therapeutics. The company’s forward-looking statements involve risks and uncertainties, and there is no assurance that ALLO-329 will successfully complete clinical development or receive regulatory approval. Trading at $1.44, the stock has declined over 63% in the past year, though InvestingPro analysis indicates the company is currently undervalued. Investors seeking deeper insights can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, which includes detailed analysis of the company’s financial health, valuation metrics, and growth prospects.
In other recent news, Allogene Therapeutics reported a narrower-than-expected loss for the fourth quarter of 2024, with earnings per share (EPS) at -$0.28, surpassing the forecasted -$0.32. The company’s revenue forecast was noted at $11.87 billion, although specific revenue figures were not disclosed. Analyst firms have been active in their evaluations of Allogene. H.C. Wainwright adjusted its price target for the company to $8.00, down from $9.00, while maintaining a Buy rating, citing the removal of ALLO-715 from its valuation model. Citi also maintained a Buy rating with an $8.00 price target, expressing optimism about Allogene’s ALPHA3 clinical study. Meanwhile, Citizens JMP upgraded the stock from Market Perform to Market Outperform, setting a price target at $5.00, based on promising clinical trial results for ALPHA3. The company continues to advance its clinical programs, with significant milestones anticipated for ALLO-329 in autoimmune diseases and ALLO-316 in renal cell carcinoma by mid-2025. Allogene’s strong cash position of $373 million supports its ongoing research and development efforts.
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