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Recordati and Moderna Partner on mRNA Therapy for Propionic Acidemia

Recordati Industria Chimica e Farmaceutica has entered into a global collaboration and license agreement with Moderna to develop and commercialize mRNA-3927, an investigational therapy for propionic acidemia (PA), a rare inherited metabolic disorder.

Under the agreement, Moderna will continue to lead the clinical development of mRNA-3927, while Recordati will assume responsibility for global commercialization if the therapy receives regulatory approval. The collaboration brings together Moderna’s expertise in mRNA-based therapies and Recordati’s established global rare disease commercial infrastructure.

mRNA-3927 is designed to restore the activity of the propionyl-CoA carboxylase (PCC) enzyme, which is deficient in patients with propionic acidemia. The condition leads to the accumulation of toxic metabolites and can result in recurrent life-threatening metabolic decompensation events, as well as neurological and cardiac complications. Currently, no approved therapies directly target the underlying cause of the disease, and treatment options are largely symptomatic, sometimes including liver transplantation.

Interim clinical data published in Nature showed early signs of clinical improvement. The therapy is currently being evaluated in a potential registrational study aimed at reducing metabolic decompensation events, with patient enrollment completed and a data readout expected by the end of 2026.

Financial terms of the agreement include a $50 million upfront payment from Recordati to Moderna, along with up to $110 million in near-term development and regulatory milestones. Moderna is also eligible for additional commercial and sales milestones, as well as tiered royalties on annual net sales. Recordati indicated that it does not expect a significant EBITDA impact prior to a potential launch. The transaction remains subject to customary closing conditions, including U.S. antitrust clearance.

Propionic acidemia affects approximately 1 in 100,000 to 150,000 individuals worldwide and is caused by pathogenic variants in the PCCA or PCCB genes, resulting in PCC deficiency.
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Author
Global Finance News 02-18-26
Recordati announced a strategic collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational mRNA therapy for propionic acidemia, a rare and life-threatening inherited metabolic disorder. Under the agreement, Moderna will continue to lead clinical development, while Recordati will take responsibility for global commercialization if the treatment is approved.

mRNA-3927 is designed to restore activity of the propionyl-CoA carboxylase enzyme, addressing the root cause of the disease rather than only managing symptoms. Interim clinical data published in Nature has shown early signs of clinical improvement, and a potential registrational study has completed patient enrollment, with key data expected by the end of 2026. If approved, the therapy could become the first disease-modifying treatment for propionic acidemia.

As part of the deal, Recordati will pay Moderna USD 50 million upfront and up to USD 110 million in near-term development and regulatory milestones, with additional commercial milestones and tiered royalties tied to sales. Recordati stated that the transaction is not expected to have a significant impact on EBITDA before a potential launch. The agreement is subject to customary closing conditions, including U.S. antitrust clearance.
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Author
Global Finance News 01-30-26