Overview
BofA Securities on Friday lowered its price target for Moderna (NASDAQ:MRNA) to $24.00 from $27.00 and reiterated an Underperform rating following a regulatory setback for the company’s influenza vaccine candidate, mRNA-1010. The new target sits well below Moderna’s recent trading level of $36.95 and at the lower end of analyst projections, which range from $17 to $135. According to InvestingPro data cited in the report, Moderna is currently judged overvalued against Fair Value estimates.
Regulatory action and company response
The price target reduction follows an FDA action in which the agency issued a Refusal to File (RTF) letter for the Biologics License Application (BLA) for mRNA-1010. BofA said the RTF letter referenced a "lack of an adequate and well-controlled study with a comparator arm that does not reflect the best-available standard of care." In response, Moderna has asked for a Type A meeting with the FDA’s Center for Biologics Evaluation and Research (CBER) to discuss next steps. Separately, the company is continuing regulatory submissions for the vaccine in the European Union, Canada, and Australia.
Analysts' view on program prospects and financial implications
BofA characterized the outlook for the flu vaccine program as having "an unclear path forward," noting several key questions remain unresolved. The bank also said the RTF could affect Moderna’s broader respiratory strategy because approval of a flu+COVID combination product would likely require approval of both component vaccines. As a result of the setback and its implications, BofA adjusted its model and now expects Moderna to reach breakeven in 2030, instead of the company’s own 2028 guidance.
Moderna has said it does not expect the RTF letter to affect its financial guidance for 2026. BofA, however, had previously projected that the bulk of revenue contribution from the flu vaccine would be realized in 2027 and beyond.
Additional corporate developments
In related corporate news, Moderna announced a five-year strategic agreement with the Mexican government and domestic pharmaceutical partners to bolster local vaccine manufacturing. The arrangement includes supplying Moderna’s respiratory vaccine portfolio to Mexico and transferring technology to enable domestic production.
Moderna also disclosed executive changes and pipeline partnerships. The company named David Berman as Chief Development Officer, effective March 2026, and said Dr. Jacqueline Miller will step down as Chief Medical Officer. In a separate collaboration, Moderna and Italian drugmaker Recordati agreed to develop and commercialize mRNA-3927 for propionic acidemia. As part of that pact, Recordati will make a $50 million upfront payment, additional milestone payments, and provide tiered royalties on future sales.
Following the Recordati deal, Leerink Partners lowered its price target for Moderna to $17 while maintaining an Underperform rating.
Market context and valuation note
BofA’s revision places its target materially beneath current market pricing and at the low end of the broker range. The combination of the FDA’s RTF and analyst downgrades has informed a more cautious near-term outlook from sell-side firms. InvestingPro data referenced in the coverage indicates Moderna is trading above Fair Value estimates, which contributes to the valuation concerns noted by analysts.
Conclusion
The FDA’s refusal to accept the BLA for mRNA-1010 has prompted BofA to reduce its price target for Moderna and delay its forecast for when the company reaches breakeven. Moderna continues to pursue regulatory review in other jurisdictions and to engage with the FDA through a requested Type A meeting, while advancing partnerships and manufacturing agreements intended to support its respiratory vaccine portfolio.
Key points
- BofA lowered Moderna’s price target to $24 from $27 and kept an Underperform rating following an FDA Refusal to File for mRNA-1010.
- The FDA’s RTF cited the comparator arm in the clinical study as not reflecting the best-available standard of care; Moderna has requested a Type A meeting with CBER and continues submissions in the EU, Canada, and Australia.
- BofA now models breakeven in 2030 rather than the company’s 2028 guidance; the setback could also affect approval prospects for a flu+COVID combination vaccine since both components would likely need approval.
Risks and uncertainties
- Regulatory risk - The FDA’s refusal to file introduces uncertainty for the mRNA-1010 program and could delay or alter approval timelines, affecting the biotech and pharmaceutical sectors.
- Commercial and financial risk - BofA’s revised breakeven projection to 2030 highlights the potential for reduced near-term revenue from the flu vaccine program, which could influence Moderna’s valuation and investor returns.
- Program dependency risk - The flu+COVID combination vaccine may depend on approval of both individual components, creating an additional pathway risk for products combining multiple vaccines.