Epicrispr Raises $90M Series C to Advance AAV-Delivered Epigenetic Therapy EPI-321 for FSHD

Aug 10 , 2026
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Aug 10, 2026 —

Epicrispr Biotechnologies announced the closing of a $90 million oversubscribed Series C financing to support pivotal clinical development of EPI-321, its lead AAV-delivered programmable epigenetic medicine for facioscapulohumeral muscular dystrophy, or FSHD.

The financing was co-led by Octagon Capital and Janus Henderson Investors, with participation from Fidelity Management & Research Company, Cormorant Asset Management, Duquesne Family Office, Sanofi Ventures, funds managed by abrdn Inc., Angelini Ventures, Readout Capital, and existing investors.

Proceeds will support advancement of EPI-321 into pivotal studies, accelerate Epicrispr’s pipeline of programmable epigenetic medicines, and expand the company’s proprietary Gene Expression Modulation System, or GEMS™, platform and manufacturing capabilities.

EPI-321 is an investigational AAV-delivered epigenetic therapy designed to address the underlying molecular mechanism of FSHD with a one-time dose. Following intravenous administration, EPI-321 is directed to muscle tissue using a single AAV vector, which the company describes as clinically validated for muscle delivery.

Unlike gene editing approaches that permanently alter DNA sequence, Epicrispr’s programmable epigenetic medicines are designed to durably regulate gene expression without changing the underlying genetic code. The GEMS platform is intended to selectively activate or silence disease-causing genes across serious genetic diseases.

In FSHD, inappropriate expression of DUX4 is a central disease driver. Preclinical studies of AAV-delivered EPI-321 demonstrated suppression of pathological DUX4 expression and reduction of muscle cell death.

Epicrispr said EPI-321 has shown a favorable safety profile and early signs of disease modification in its ongoing first-in-human trial. Reported interim findings included statistically significant increases in whole-body lean muscle volume measured by MRI, circulating biomarker changes consistent with DUX4 suppression, favorable strength and functional outcomes, and a manageable safety profile.

Enrollment in the EPI-321 Phase 1/2 trial has been completed, with additional clinical data expected later this year.

As part of the financing, Anran Li, Ph.D., of Octagon Capital will join Epicrispr’s Board of Directors.

The financing positions Epicrispr to advance a potential first AAV-delivered epigenetic therapy for FSHD into pivotal development while continuing to build a broader pipeline of programmable epigenetic medicines.

Source:

https://www.businesswire.com/news/home/20260810422396/en/Epicrispr-Biotechnologies-Closes-%2490-Million-Oversubscribed-Series-C-Financing-to-Advance-First-in-Class-Epigenetic-Therapy-Toward-Pivotal-Studies-in-FSHD

About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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