Global pharma powerhouse Moderna has announced a strategic collaboration with Italian pharmaceutical company Recordati to globally commercialize its investigational propionic acidemia (PA) therapy, mRNA-3927.

Under the agreement, Moderna will continue leading clinical development and manufacturing, while Recordati will spearhead commercialization.

The deal provides Moderna with $50 million upfront and up to $110 million in near-term development and regulatory milestones, plus additional commercial milestones and tiered royalties on net sales. The agreement awaits customary closing conditions, including US antitrust clearance expected within 30 days.

“We are proud to partner with Recordati in a joint mission to improve the lives of people living with propionic acidemia,” said Stéphane Bancel, CEO of Moderna. “Recordati brings deep rare disease commercial expertise and an established global commercial infrastructure in propionic acidemia that will help us accelerate the benefit of mRNA-3927 upon approval.”

Rob Koremans, CEO of Recordati, added, “Propionic acidemia is a serious rare disease with a significant unmet medical need due to the lack of disease modifying treatment options to date. We look forward to partnering with Moderna.

"Their experience in applying innovative mRNA technology, combined with our experience in rare metabolic disorders and strong established commercial infrastructure, positions us well to advance this potential therapy together to serve patients. We are encouraged by the clinical data and look forward to the pivotal readout expected in 2026. This deal strengthens our development portfolio and builds on our heritage in the metabolic field.”

mRNA-3927 is being evaluated in a registrational study that has reached target enrollment, with pivotal data expected in 2026. The therapy uses two mRNAs to produce normal human PCCA and PCCB enzymes, aiming to address the root cause of PA—a rare, inherited metabolic disorder that affects 1 in 100,000–150,000 people worldwide and currently has no effective treatments.

Early Phase 1/2 studies suggest mRNA-3927 shows potential clinical benefit with minimal treatment-limiting side effects.

Moderna continues to expand its footprint in mRNA therapeutics, developing medicines across infectious disease, cancer, and rare diseases.