Regeneron drops after skin cancer treatment fails late-stage trial


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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