By Michael Dabaie
Agenus Inc. shares were down 22% to $3.98 in premarket trading Friday after the immuno-oncology company said it is withdrawing its biologics license application for balstilimab.
The decision to withdraw the biologics license application doesn't change the development plans for balstilimab combinations, the company said.
Following the full approval of pembrolizumab, or Keytruda, the U.S. Food and Drug Administration no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw, the company said. Merck & Co. earlier this month said that the FDA approved Keytruda in cervical cancer.
"While the commercial market for balstilimab monotherapy in second line cervical cancer was always anticipated to be small, Agenus' priority remains developing balstilimab as a necessary component of highly effective and affordable combination therapies, both with its own portfolio and with partners, including in combination with Agenus' next-generation CTLA-4, AGEN1181," Agenus Chief Executive Garo Armen said.
Agenus said it will discontinue its ongoing confirmatory trial, which is expected to reduce research and development expenses by more than $100 million.
Given the clinical benefit demonstrated by balstilimab, Agenus said it plans to launch expanded access programs to give patients and doctors access to balstilimab in several countries, including the U.S., pending regulatory processes.
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(END) Dow Jones Newswires