Regeneron Downgraded After Fianlimab Trial Misses PFS Threshold (p=0.0627)
Regeneron’s phase 3 trial of fianlimab plus cemiplimab failed to reach statistical significance for progression-free survival versus Keytruda, delivering median PFS of 11.5 months versus 6.4 months with a p-value of 0.0627. Citi cut its rating to neutral and price target from $900 to $700, while BMO lowered its target by nearly 20%.
1. Trial Results and Statistical Outcome
Regeneron reported that its phase 3 trial combining fianlimab with cemiplimab did not achieve statistical significance on the primary endpoint of progression-free survival versus Keytruda. The combination extended median PFS to 11.5 months compared with 6.4 months for Keytruda alone, but the p-value of 0.0627 fell short of the conventional 0.05 threshold.
2. Analyst Downgrades and Price Target Cuts
Following the trial miss, Citi downgraded Regeneron to neutral from buy and trimmed its price target from $900 to $700. BMO also reduced its target by nearly 20%, citing the melanoma trial readout as the defining catalyst of the first half of 2026.
3. Implications for Fianlimab’s Commercial Prospects
The setback compounds earlier phase 2 data shortfalls in non-small cell lung cancer, narrowing the drug’s addressable market. A separate phase 3 trial versus Bristol-Myers Squibb’s Opdualag remains ongoing, but the melanoma miss raises concerns over the programme’s ability to secure regulatory approval and commercial traction.