REGENXBIO Reports Q2 2025 Financial Results, Advances Gene Therapy Pipeline

RegenXBio Inc. reported Q2 2025 earnings with a net loss and decreased revenues to $21.4 million due to reduced Zolgensma royalties. However, the company's cash position improved to $363.6 million, supported by strategic partnerships and royalty monetization agreements. RegenXBio is on track with pivotal trials for RGX-202 and surabgene lomparvovec, with potential FDA approvals and commercial launches expected in 2026.

RegenXBio Inc. reported its Q2 2025 earnings, revealing a challenging quarter with declining revenue and expanded net losses. The company's total revenue for the period fell by 4.2% year-over-year to $21.36 million, primarily driven by a reduction in service revenue [1]. Despite these financial setbacks, RegenXBio advanced its gene therapy pipeline, including progress toward potential FDA approval of RGX-121 and momentum in pivotal trials.

The company's net loss widened significantly, reaching $-70.87 million, a 33.7% increase from the $-52.99 million loss in the same period last year [1]. Curran M. Simpson, President and CEO of RegenXBio, emphasized the company's strategic momentum, highlighting the potential FDA approval of RGX-121 in November 2025 and the advancement of RGX-202 pivotal trials ahead of schedule [1]. The company is also preparing for commercial-scale manufacturing of RGX-202 in Q3 2025 to support a projected 2027 launch [1].

RegenXBio's stock has continued to trend downward, reflecting investor concerns over profitability and long-term R&D timelines. The stock has lost 9.61% month-to-date, with a 1.25% drop on the most recent trading day [1].

The company announced a pivotal Phase IIb/III clinical trial for surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery. This clinical advancement follows new, positive two-year data from the Phase II ALTITUDE® trial [2]. RegenXBio will receive $100 million upon first subject dosed in the Phase IIb/III clinical trial and an additional $100 million upon first subject dosed in a second Phase III clinical trial [2].

Despite the financial challenges, RegenXBio's cash position improved to $363.6 million, supported by strategic partnerships and royalty monetization agreements [1]. The company remains focused on its long-term therapeutic pipeline to drive value, with potential FDA approvals and commercial launches expected in 2026.

References:
[1] https://www.ainvest.com/news/regenxbio-2025-q2-earnings-wider-losses-progress-gene-therapy-pipeline-2508/
[2] https://www.marketscreener.com/news/regenxbio-announces-pivotal-program-for-surabgene-lomparvovec-in-diabetic-retinopathy-ce7c5edfda88ff26