By Christy Santhosh
May 18 (Reuters) – Shares of Regeneron fell 11.6% premarket on Monday after the company’s experimental treatment missed the main goal in a late-stage head-to-head trial for patients with a type of skin cancer.
Late on Friday, the drugmaker said its fianlimab-cemiplimab combination did not reach statistical significance in improving progression-free survival (PFS), the length of time patients with advanced melanoma live without the disease worsening.
This marks another major setback for the drugmaker, following 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.
In the 1,546-patient late-stage trial, the high-dose fianlimab combination with cemiplimab, sold as Libtayo, showed a 5.1-month numeric improvement in median PFS versus Merck’s Keytruda, but the difference was not statistically significant.
“These results are the worst-case scenario,” said Evercore analyst Cory Kasimov, adding that while the fundamental impact is relatively limited at this point, sentiment would likely weaken further.
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. About 112,000 new melanomas will be diagnosed this year, according to the American Cancer Society.
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)
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