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SOUTH SAN FRANCISCO - The U.S. Food and Drug Administration (FDA) has awarded Regenerative Medicine Advanced Therapy (RMAT) designation to LYL314, a therapy developed by Lyell Immunopharma, Inc. (NASDAQ: LYEL) for treating relapsed and/or refractory large B-cell lymphoma. This decision follows the presentation of promising clinical data from an ongoing Phase 1/2 trial. The company, currently valued at $131 million, maintains a strong financial position with more cash than debt on its balance sheet, according to InvestingPro data.
LYL314, formerly known as IMPT-314, is a next-generation CAR T-cell therapy targeting both CD19 and CD20 to potentially improve complete response rates and extend response duration compared to existing CD19-targeted treatments. The RMAT designation is expected to expedite the development and review process by enabling more frequent interactions with the FDA.
In a recent trial involving 23 patients with relapsed or refractory large B-cell lymphoma, LYL314 demonstrated an overall response rate of 94%, with 71% achieving a complete response within three months. The median follow-up period was 6.3 months, with 71% of patients maintaining their response at the last follow-up. Notably, no patients experienced Grade 3 or higher cytokine release syndrome, and immune effector cell-associated neurotoxicity syndrome was manageable. The positive clinical data has contributed to a significant 7.6% stock price increase over the past week, though the shares remain down 62% over the last six months. InvestingPro subscribers have access to 13 additional key insights about LYEL’s performance and outlook.
Lyell Immunopharma plans to present additional data from this trial later in 2025, including outcomes for patients treated in both 3rd or later line and 2nd line settings. The company also anticipates initiating two pivotal programs for LYL314, one for patients in the 3rd or later line setting by mid-2025 and another for those in the 2nd line setting by early 2026.
The RMAT designation, part of the 21st Century Cures Act, is aimed at advancing regenerative medicine therapies for serious or life-threatening conditions by providing benefits similar to the Fast Track and Breakthrough Therapy programs. This includes the possibility of accelerated approval based on surrogate or intermediate endpoints.
Lyell Immunopharma focuses on next-generation CAR T-cell therapies for cancer patients, aiming to enhance the durability and consistency of clinical responses. The company’s approach includes technologies to help CAR T cells resist exhaustion, maintain stem-like qualities, and function effectively in the tumor microenvironment. While the company maintains a healthy current ratio of 7.06 and its liquid assets exceed short-term obligations, InvestingPro analysis indicates the company is rapidly burning through cash, with a negative free cash flow yield. Discover more detailed financial metrics and expert analysis with an InvestingPro subscription.
The information in this article is based on a press release statement from Lyell Immunopharma, Inc.
In other recent news, Lyell Immunopharma announced the closure of its West Hills facility, resulting in the reduction of approximately 73 jobs. This decision follows the successful technology transfer to the LyFE manufacturing center in Bothell, Washington, which has received FDA clearance to manufacture the drug candidate IMPT-314 for clinical trials. The closure is expected to incur costs between $3.0 million and $4.0 million, primarily due to severance and related expenses. In a separate development, H.C. Wainwright maintained a Neutral rating on Lyell Immunopharma, with a price target of $1.00, as they monitor the progress of the IMPT-314 trials. The firm expressed interest in upcoming trial data, noting the competitive landscape for CAR-T therapies. Additionally, Lyell Immunopharma received a notification from Nasdaq for non-compliance with the minimum bid price requirement. The company has until July 22, 2025, to regain compliance, with options including a potential reverse stock split under consideration. Investors are closely watching these developments as Lyell Immunopharma navigates the Nasdaq listing requirements.
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