Moderna Inc (NASDAQ:MRNA, XETRA:0QF) shares fell almost 6% after the drugmaker announced that the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has issued a Refusal-to-File (RTF) letter for the company’s biologics license application for its investigational seasonal influenza vaccine, mRNA-1010.
According to the company, the FDA cited the choice of a licensed standard-dose influenza vaccine as the comparator in Moderna’s Phase 3 trial as the reason for the refusal.
The RTF letter did not identify any safety or efficacy concerns with mRNA-1010, the company highlighted.
Moderna noted that the refusal is inconsistent with prior communications from CBER, including pre-Phase 3 and pre-submission guidance. In response, the company has requested a Type A meeting with the FDA to clarify the path forward. Moderna has made the full RTF letter publicly available on its website.
The company said that mRNA-1010 has been submitted and accepted for review in the European Union, Canada, and Australia, with additional submissions planned for 2026. Moderna expects potential approvals to begin in late 2026 or early 2027, depending on ongoing regulatory reviews.
Moderna also indicated that the RTF from CBER is not expected to affect its 2026 financial guidance.
"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines," Moderna CEO Stéphane Bancel said in a statement.
“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America's seniors, and those with underlying conditions, continue to have access to American-made innovations."