Regeneron Drops 12% After Melanoma Drug Misses Phase 3 Goal, Erasing $9 Billion

7 articles · Updated · CNBC · May 18

$612.06 shares put Regeneron on track to lose about $9 billion in market value after its fianlimab-cemiplimab melanoma regimen failed a late-stage trial's main endpoint.
In the 1,546-patient study, the combo extended median progression-free survival by about five months versus Merck's Keytruda, but the difference was not statistically significant.
At least 10 brokerages cut price targets, and some analysts called the result a worst-case outcome that raises pressure on Regeneron's next 12 to 18 months of clinical development.
The setback follows regulatory delays for a pre-filled Eylea syringe and last year's late-stage itepekimab failure, while a separate head-to-head melanoma trial against Bristol Myers Squibb's Opdualag is still underway.
Separately, Regeneron said Monday it will partner with Parabilis Medicines in a deal that could bring up to $2.2 billion in milestone payments tied to new therapies.

With its blockbuster hope dashed, can Regeneron's pivot to radiopharmaceuticals salvage its oncology ambitions?

Despite failing statistics, could fianlimab's data hide a key to beating melanoma in specific patients?

A 5-month survival gain wasn't enough. Is the FDA's standard for new cancer drugs too rigid?