Moderna Shares Plunge After Reported Data Leak
Moderna shares plunge after a leaked ESMO report; traders face unverified efficacy claims and higher volatility until the full trial dataset is presented.
KEY TAKEAWAYS
- A briefly posted then removed partial INTerpath-001 dataset preceded the share plunge and lacked verification.
- Companies had announced the trial met RFS and DMFS endpoints but withheld detailed hazard ratios and safety tables.
- Full INTerpath-001 results were scheduled for an ESMO presentation, forming the required basis for regulatory filings.
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Moderna Inc. (MRNA) shares plunged on Oct. 22, 2026, after a partial online posting of INTerpath-001 Phase 3 melanoma vaccine data was briefly available and removed before the companies’ scheduled Oct. 24 presentation at the European Society for Medical Oncology (ESMO) Congress. Moderna and Merck had announced on Aug. 19 that the trial met its primary and a key secondary endpoint.
Phase 3 Results and Trial Details
INTerpath-001 was a randomized Phase 3 trial testing intismeran autogene (mRNA-4157/V940) plus pembrolizumab (Keytruda) against placebo plus pembrolizumab in 1,137 patients with completely resected stage IIB, IIC, III, or IV cutaneous melanoma who had not received prior systemic therapy. The treatment is intended as adjuvant therapy to reduce recurrence after surgery. Moderna and Merck are jointly developing the personalized mRNA therapy alongside pembrolizumab.
The companies announced on Aug. 19 that the trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant-metastasis-free survival (DMFS) at a prespecified interim analysis. They reported no new safety signals in Phase 3 and said overall survival remained under evaluation, with detailed safety data still pending.
Earlier five-year Phase 2b data presented at the 2026 American Society of Clinical Oncology meeting showed a 49% reduction in the risk of recurrence or death, with a hazard ratio of 0.51 and a 95% confidence interval of 0.294–0.887, providing context for the Phase 3 results. Moderna and Merck described the Phase 3 findings as showing a “clinically meaningful” and statistically significant improvement in recurrence-free survival.
Leak and Timeline
A third-party posting briefly available online reportedly included specific figures: a 42% reduction in the risk of recurrence or death and two-year recurrence-free survival rates of 82.2% for the combination versus 70.0% for pembrolizumab alone. These numbers were not an official company disclosure, had not been peer-reviewed, and could not be independently validated from available primary materials.
The companies plan to present the full INTerpath-001 dataset at the scheduled ESMO session (abstract LBA1) and said they will work with regulators on potential filings. Reports indicate they are preparing an FDA submission, though no filing date or review status has been publicly identified. Observers emphasize that efficacy conclusions remain conditional on the full ESMO dataset, including hazard ratios, confidence intervals, event counts, safety tables, and longer-term follow-up. The program remains investigational with no FDA approval, filing acceptance, or formal review reported, and no new government safety actions have been announced.
