RECORDATI ANNOUNCES STRATEGIC COLLABORATION WITH MODERNA TO DEVELOP AND COMMERCIALIZE WORLDWIDE mRNA 3927 FOR THE TREATMENT OF PROPIONIC ACIDEMIA
MWN-AI** Summary
Recordati has announced a strategic collaboration with Moderna to develop and commercialize mRNA-3927, an investigational product targeting propionic acidemia (PA), a rare inherited metabolic disorder. This partnership leverages Moderna's mRNA technology and Recordati's established global infrastructure in rare diseases. Under the terms of the agreement, Moderna will lead the development of mRNA-3927, while Recordati will handle global commercialization following potential approval.
mRNA-3927 aims to address the underlying cause of PA, which arises from a deficiency of the propionyl-CoA carboxylase (PCC) enzyme, leading to toxic metabolite accumulation. Patients often experience severe symptoms from early childhood, including metabolic decompensation, which can be life-threatening. Currently, treatment options are limited to symptomatic management, making mRNA-3927 potentially the first effective disease-modifying therapy for this condition.
Recent interim clinical data, published in Nature, indicated promising signs of clinical benefit associated with mRNA-3927, which is undergoing evaluation in a registrational clinical study. With patient enrollment completed, a data readout is anticipated by the end of 2026.
The collaboration includes an upfront payment of $50 million from Recordati to Moderna, with potential additional payments of up to $110 million tied to development and regulatory milestones. In addition, Moderna could receive commercial and sales milestones alongside tiered royalties on net sales.
Recordati's CEO, Rob Koremans, expressed optimism about the partnership, emphasizing the importance of addressing the significant unmet medical need in PA. Moderna's CEO, Stéphane Bancel, echoed this sentiment, highlighting their commitment to improving patient outcomes through innovative therapies. This collaboration signals a promising advancement in the treatment landscape for patients with propionic acidemia.
MWN-AI** Analysis
**Market Analysis and Investment Perspective on Recordati’s Collaboration with Moderna**
Recordati’s recent collaboration with Moderna to develop and commercialize mRNA-3927 for propionic acidemia presents a significant strategic opportunity within the rare metabolic disorder sector. Propionic acidemia (PA), affecting approximately 1 in 100,000-150,000 individuals, currently lacks effective disease-modifying treatments, making mRNA-3927 a potentially groundbreaking option.
This agreement leverages Moderna’s advanced mRNA technology, paired with Recordati’s established presence in the rare disease landscape, enhancing the chances of successful development and commercialization. Notably, interim clinical data has shown early signs of clinical improvement in patients, a promising indicator ahead of pivotal data expected by the end of 2026. If mRNA-3927 receives regulatory approval, it could lead Recordati into a strong market position, addressing a significant unmet medical need.
Financially, the proposed payment structure, including an initial $50 million payment, is balanced by potential milestones totaling up to $110 million. This strategic expenditure is likely to be viewed favorably by investors, who often favor partnerships that blend innovation with established commercial capabilities. Importantly, Recordati does not anticipate significant EBITDA impacts until potential product launch, minimizing immediate financial strain.
From a market perspective, Recordati (XMIL: REC) is well-positioned for growth. The collaboration not only diversifies its product portfolio but also reinforces its market strength in rare diseases. Investors may find value in this strategic move, particularly as the company continues to expand its role in therapeutic innovations.
Given the current climate focusing on rare diseases and innovative therapies, Recordati offers potential upside in a sector that promises growth. Investors should monitor the clinical development outcomes closely, as positive results could catalyze significant stock appreciation, enhancing Recordati's valuation in a competitive pharmaceutical landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
mRNA-3927 is a strong strategic fit with Recordati’s rare Metabolic portfolio
Collaboration combines Moderna’s expertise in mRNA technology for rare metabolic disorders with Recordati’s established global rare disease commercial infrastructure
Moderna will continue to lead development for mRNA-3927, and if approved, Recordati will lead global commercialization efforts
Milan, 29 January 2026 – Recordati today announced that it has entered into a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization.
mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. Propionic acidemia is a rare inherited metabolic disorder which is caused by defective mitochondrial enzymes (PCC) leading to abnormal toxic metabolite build up and organic acidemia. The disease often presents in early childhood with general symptoms of malaise but can progress with brain and cardiac damage and is associated with significant mortality. Current treatment options are symptomatic and may ultimately also include liver transplant. If approved, this could be the first disease-modifying treatment option on the market for this severe disease.
mRNA-3927 is a targeted disease modifying therapy in clinical development. Interim clinical data was recently published in the prestigious journal Nature showing early signs of clinical improvement. mRNA-3927 is currently being evaluated in a potential registrational clinical study with the aim to reduce the risk of metabolic decompensation events in these patients. The target patient enrollment has been reached, with a potential data readout expected by the end of 2026.
Under the terms of the agreement, Recordati will pay Moderna an upfront payment of USD 50 million and up to an additional USD 110 million in near-term development and regulatory milestones. Moderna is also eligible to receive commercial and sales milestones, as well as tiered royalties on annual net sales. Recordati does not expect any significant impact on its EBITDA prior to a potential launch.
The transaction is subject to customary closing conditions, including U.S. antitrust clearance which is expected within 30 days from the relevant filing.
Rob Koremans, Chief Executive Officer, Recordati, commented, “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 by the end of 2026. This deal strengthens our development portfolio and builds on our heritage in the metabolic field.”
Stéphane Bancel, Chief Executive Officer of Moderna, added, “We are proud to partner with Recordati in a joint mission to improve the lives of people living with propionic acidemia. 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.”
About propionic acidemia (PA)
Propionic acidemia is a rare, serious, inherited metabolic disorder with significant morbidity and mortality, affecting 1 in 100,000-150,000 individuals worldwide. PA is caused by pathogenic variants in the propionyl-coenzyme A carboxylase (PCC) ? or ? subunits (PCCA and PCCB genes, respectively), leading to PCC deficiency and subsequent accumulation of toxic metabolites. PA is characterized by recurrent life-threatening metabolic decompensation events (MDEs) and multisystemic complications. Currently, there are no effective therapies for PA that target the underlying root cause of the disease.
About mRNA-3927
mRNA-3927 is an investigational novel mRNA-based therapeutic agent that is composed of two mRNAs encoding for normal human PCCA and PCCB subunits. Intravenous (IV) administration of mRNA-3927 is intended to restore functional PCC enzymes in patients with PA.
Interim data from a first-in-human, phase 1/2, open-label, dose optimization study and extension study evaluating the safety and efficacy of mRNA-3927 indicate early signs of potential clinical benefit and demonstrate that mRNA-3927 has infrequent treatment-limiting side effects.
mRNA-3927 is currently being evaluated in a potential registrational clinical study with the aim to reduce the risk of metabolic decompensation events in these patients (NCT04159103).
Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,500 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest.
Investor Relations
Eugenia Litz eugenia.litz@recordati.com
Gianluca Saletta saletta.g@recordati.it
Media Relations
Laura Conti conti.l@recordati.it
Rebecca Kerr rebecca.kerr@recordati.com
This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast as a result of a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising.
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A.
Registered office VIA M. CIVITALI, 1 20148 MILAN, ITALY
TEL. +39 0248787.1
FAX +39 0240073747
SHARE CAPITAL € 26,140,644.50 fully paid up
BUSINESS REGISTER OF MILAN, MONZA, BRIANZA and LODI 00748210150 TAX CODE/VAT NO. 00748210150
MILAN ECONOMIC AND ADMINISTRATIVE INDEX (REA) 401832
Company subject to management and coordination by Rossini Luxembourg S.àr.l
FAQ**
How does the collaboration between Moderna and Recordati, specifically regarding mRNA-3927, enhance Recordati Industria Chim RCDTF’s position in the rare metabolic disorders market compared to existing treatment options for propionic acidemia?
What specific milestones and regulatory conditions must be met for mRNA-39to progress to commercialization, and how does Recordati Industria Chim RCDTF plan to manage these phases following the expected readout at the end of 2026?
Given the significant upfront and milestone payments to Moderna, how does Recordati Industria Chim RCDTF anticipate balancing its financial commitments while investing in the marketing and infrastructure needed for mRNA-3927?
What strategies will Recordati Industria Chim RCDTF employ to educate healthcare providers and patients about the potential impact of mRNA-3927 as a disease-modifying treatment for propionic acidemia once it receives approval?
**MWN-AI FAQ is based on asking OpenAI questions about Recordati Industria Chim (OTC: RCDTF).
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