Regeneron’s Drug Combo Fails To Prove Superiority Over Merck’s Keytruda In Melanoma

• While the fianlimab arm showed a numerical improvement in progression-free survival, the difference was not statistically significant, Regeneron said.
• The company is continuing a separate late-stage trial comparing the same combination against Bristol Myers Squibb’s Opdualag.
• The setback is a disappointment for Regeneron as it tries to carve out a position in the fast-growing melanoma immunotherapy market.

Regeneron Pharmaceuticals (REGN) shares slipped marginally in after-hours trading on Friday after the company reported that its experimental drug fianlimab, combined with its approved medicine Libtayo, failed to meet the main goal of a pivotal late-stage melanoma trial.

The late-stage study tested the combination against Merck’s blockbuster drug Keytruda in patients with advanced melanoma. While the fianlimab arm showed a numerical improvement in progression-free survival, the difference was not statistically significant, Regeneron said.

In the high-dose arm, patients lived a median of 11.5 months without their cancer worsening, compared with 6.4 months for those on Keytruda alone. The lower-dose arm also fell short of statistical significance. No new safety concerns were reported, the company said.

Regeneron said full results will be presented at a future medical meeting. The company is continuing a separate late-stage trial comparing the same combination against Bristol Myers Squibb’s Opdualag.

The setback is a disappointment for Regeneron as it tries to carve out a position in the fast-growing melanoma immunotherapy market. Fianlimab plus Libtayo remains an investigational therapy with no approved indication yet.

According to data from Koyfin, 22 of the 29 analysts covering REGN stock rate it ‘Buy’ or ‘higher’ while seven rate it ‘Hold’. The average 12-month price target on the stock is $875.31, representing a potential upside of about 25% from the last close.

How Did Retail Traders React?

On Stocktwits, retail sentiment around REGN stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

A Stocktwits user opined that REGN is in a “short-term downtrend.”

REGN stock has gained 19% over the past 12 months. 

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