Moderna and Recordati announce collaboration on mRNA-3927, an investigational mRNA therapy for propionic acidemia (PA). Details on $50M upfront deal, clinical trials, and global commercialization plans. Data readout expected 2026.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Moderna, Inc. has entered into a strategic collaboration with Recordati to advance the development and future commercialization of mRNA-3927, an investigational therapy for propionic acidemia (PA), a rare and life-threatening inherited metabolic disorder.
The partnership is aimed at supporting mRNA-3927 through the final stages of clinical development and, if approved, bringing the therapy to patients globally.
Development and Commercialization Responsibilities
Under the terms of the agreement, Moderna will continue to lead the clinical development of mRNA-3927 through regulatory approval, while Recordati will assume responsibility for global commercialization.
Stéphane Bancel, Chief Executive Officer of Moderna, said the collaboration reflects a joint commitment to improving the lives of patients living with propionic acidemia. He highlighted Recordati’s established rare disease commercial infrastructure as a key factor in accelerating patient access upon approval.
Recordati CEO Rob Koremans described propionic acidemia as a serious condition with significant unmet medical need, noting the lack of disease-modifying treatment options available today. He added that the company is encouraged by existing clinical data and is looking ahead to the pivotal study readout expected in 2026.
Financial Terms of the Transaction
As part of the agreement:
- Moderna will receive an upfront payment of $50 million
- The company is eligible for up to $110 million in additional near-term development and regulatory milestone payments
- Moderna may also receive further commercial and sales-based milestones
- Recordati will pay tiered royalties on net sales following commercialization
The transaction remains subject to customary closing conditions, including U.S. antitrust clearance, which is expected within 30 days of the relevant filing.
Clinical Development Update
mRNA-3927 is currently being evaluated in a registrational clinical study, which has already reached its target enrolment.
Moderna expects a potential clinical data readout in 2026, which could support regulatory submissions and future approval.
Propionic Acidemia: A Rare and Severe Genetic Disorder
Propionic acidemia is a rare inherited metabolic disease affecting approximately 1 in 100,000 to 150,000 individuals worldwide.
The condition is caused by pathogenic variants in the PCCA or PCCB genes, which encode the alpha and beta subunits of the enzyme propionyl-coenzyme A carboxylase (PCC). Deficiency of this enzyme leads to the accumulation of toxic metabolites in the body.
PA is characterized by:
- Recurrent life-threatening metabolic decompensation events (MDEs)
- Multisystem complications
- High morbidity and mortality
Currently, there are no approved therapies that directly address the underlying cause of the disease.
About mRNA-3927
mRNA-3927 is an investigational mRNA-based therapeutic composed of two mRNAs encoding normal versions of the PCCA and PCCB subunits.
The therapy is administered intravenously with the goal of restoring functional PCC enzyme activity in patients with propionic acidemia.
Interim results from a first-in-human Phase 1/2 open-label dose optimization study (NCT04159103) and extension study (NCT05130437) have shown early signs of potential clinical benefit. The studies also reported infrequent treatment-limiting side effects, supporting further advancement into registrational evaluation.
Reference
Moderna Announces Strategic Collaboration with Recordati to Globally Commercialize Investigational Propionic Acidemia Therapeutic (mRNA-3927), January 30, 2026. https://feeds.issuerdirect.com/news-release.html?newsid
RECORDATI ANNOUNCES STRATEGIC COLLABORATION WITH MODERNA TO DEVELOP AND COMMERCIALIZE WORLDWIDE mRNA 3927 FOR THE TREATMENT OF PROPIONIC ACIDEMIA, 29 January 2026, https://d2e3isjppdvvam.cloudfront.net/wp-content/uploads/2026/01/29220357/Recordati-Strategic-Collaboration-with-Moderna-290126.pdf
Open-Label Study of mRNA-3927 in Participants with Propionic Acidemia ClinicalTrials.gov ID NCT04159103, https://clinicaltrials.gov/study/NCT04159103
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study, ClinicalTrials.gov ID NCT05130437, https://clinicaltrials.gov/study/NCT05130437