By Christy Santhosh
May 18 (Reuters) – Regeneron’s shares fell 12% in morning trade on Monday after the company’s experimental treatment missed the main goal in a late-stage trial for patients with a type of skin cancer.
The drugmaker said late on Friday its combination of fianlimab and cemiplimab did not reach statistical significance in improving the time that patients with advanced melanoma live without the disease worsening.
The setback is the latest for the drugmaker after U.S. regulatory delays for a pre-filled syringe version of its eye drug Eylea and last year’s late-stage failure of its lung disease drug, itepekimab.
“Back-to-back key pipeline misses amp up the pressure on the next 12 to 18 months of clinical development,” said BMO Capital Markets analyst Evan Seigerman.
Shares of the company fell to $612.06, putting it on track to lose about $9 billion in market value. At least 10 brokerages cut their price target on Regeneron’s stock.
In the 1,546-patient trial, those given the high-dose fianlimab combination with cemiplimab, sold as Libtayo, had median progression-free survival of about five months longer than patients on Merck’s Keytruda, but the difference was not statistically significant.
“These results are the worst-case scenario,” said Evercore analyst Cory Kasimov, adding sentiment would likely worsen even though the business impact was relatively limited currently.
Regeneron is conducting a separate head-to-head trial comparing the fianlimab combination with Bristol Myers Squibb’s Opdualag. At least two brokerages said they have low confidence in a potential positive outcome from this trial.
Advanced melanoma is a serious form of skin cancer that can spread rapidly to other parts of the body, making it harder to treat.
Separately, Regeneron said on Monday it is partnering with privately held Parabilis Medicines, which could receive up to $2.2 billion in milestone payments to develop new treatments for hard-to-reach disease targets.
(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid and Devika Syamnath)
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