Agenus Shares Down 22% After Withdrawing BLA for Balstilimab
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
"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.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires
October 22, 2021 09:39 ET (13:39 GMT)
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