Andelyn Biosciences to Manufacture Evolyra’s LGMD Gene Therapies Using AAV Curator Platform

New updates have been reported about Andelyn Biosciences.

Andelyn Biosciences has entered a manufacturing partnership with Evolyra Therapeutics to produce clinical-grade AAV gene therapies for limb-girdle muscular dystrophy subtypes LGMDR3 and LGMDR5, placing its AAV Curator® Platform at the center of Evolyra’s IND-enabling and early clinical work. Under the agreement, Andelyn will support process development and GMP production to back an IND filing targeted for the second half of 2026 and subsequent Phase I/II trials.

The engagement strengthens Andelyn’s position as a specialist CDMO for rare neuromuscular diseases, giving it exposure to an addressable market estimated at $11 billion for LGMDR3 and LGMDR5 within a broader LGMD market exceeding $100 billion globally. Evolyra’s preclinical data, showing full protein expression and muscle restoration in animal models with its AAVMYO2 muscle-targeted vector, could translate into recurring manufacturing demand for Andelyn if clinical results are positive.

Financial terms were not disclosed, but the program is supported by Evolyra’s recently closed $5 million seed round and an ongoing $20 million Series A raise, which is expected to fund progression through early clinical development and associated manufacturing spend at Andelyn. Executives from both companies emphasized that the AAV Curator platform is designed to streamline transitions from preclinical to clinical phases, which may compress timelines and improve capacity utilization across Andelyn’s facilities in Columbus, Ohio.

The deal leverages Andelyn’s more than 20 years of viral vector experience, including production of cGMP material for over 500 clinical batches and 85 clinical trials, and provides another reference program for its configurable, data-driven platform approach. With cGMP capabilities across suspension bioreactors up to 2,000 liters and adherent processes, Andelyn is positioned to scale these LGMD programs from early-stage trials toward potential commercial supply if the therapies advance successfully.

For executives and investors, this partnership signals continued demand for specialized AAV manufacturing capacity amid growing gene therapy pipelines, particularly in rare neuromuscular indications where safety and muscle-targeted efficacy are critical. Strategically, the collaboration expands Andelyn’s footprint in high-value rare disease markets, deepens its portfolio in muscular dystrophy, and may create longer-term revenue visibility tied to Evolyra’s platform if it is extended beyond LGMDR3 and LGMDR5 to additional LGMD subtypes and other genetic disorders.