Eli Lilly is dropping the development of three therapies that did not meet expectations, including a gene therapy acquired during a $1bn buyout of Prevail Therapeutics.
Lilly is terminating the development of gene therapy LY3884963, as reported by Fierce Pharma, which it acquired during a buyout of Prevail Therapeutics in March 2022. The gene therapy is in a Phase I/II trial (NCT04408625) in frontotemporal dementia with progranulin mutations (FTD-GRN). The trial has a completion date in April 2031.
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A spokesperson for Eli Lilly told Clinical Trials Arena: “Lilly discontinued GRN gene therapy in frontotemporal dementia due to a lack of compelling efficacy in the studied patient population. The decision was not due to any safety concern. Subjects enrolled as of the date of discontinuation will be followed for the protocol-defined safety follow-up period. While we recognise the significant unmet medical need in this area, we remain committed to assessing future opportunities that best support our strategic priorities and portfolio focus. We aim to leverage insights gained from this programme in upcoming interventions and are planning to share the data at a forthcoming scientific meeting.”
The second candidate that has been terminated is LY3541860, an anti-CD19 antibody being investigated in multiple sclerosis (MS) and rheumatoid arthritis (RA). The drug is in a Phase II (NCT06220669) in patients with relapsing MS, with LY3541860 being pitted against a placebo. The study is currently listed as “recruiting”, with the study completion due in August 2028. Meanwhile, the Phase II trial (NCT06859294) in RA is a single-arm study, which is currently listed as “active, not recruiting” with a completion due in September 2026.
Finally, the pharma giant is terminating the development of AC-225-PSMA-62, an investigational radioligand therapy which is in a Phase I/II trial (NCT06229366) in prostate cancer. The trial status on ClinicalTrials.gov continues to be “active, not recruiting”, with a study completion in December 2032.
The Lilly spokesperson added that the development of the anti-CD19 antibody and radioligand therapy have been terminated due to efficacy concerns, adding that safety was not a concern in any of the programmes.
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By GlobalDataThe drugs were all excluded from Lilly’s Q4 2025 presentation. On the same day, during the publication of its financials, Lilly said it anticipates revenue of between $80bn and $83bn in 2026, with hopes that orforglipron will enter the market.
In 2025, Lilly’s total revenue reached $65.2bn, a significant increase from the $45bn recorded in 2024, with the company’s share value jumping 7.1%.
The termination of LY3884963 comes despite Lilly signing multiple deals in the gene therapy space in the past year. In January 2026, the company outlaid $1.2bn for a partnership with hearing loss gene therapy developer Seamless Therapeutics. In 2025, the drugmaker signed a licensing deal with Rznomics, a South Korea-based biotech developing RNA-based therapies, and acquired gene editing partner Verve Therapeutics, in separate deals worth $1.3bn each.
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