AnaptysBio Shares Rise 11% After Jemperli Plus Chemotherapy Approved in U.S.
01 August 2023 - 4:27AM
Dow Jones News
By Chris Wack
AnaptysBio shares were 11% higher after GSK received U.S. Food
and Drug Administration approval for a treatment indication using a
drug it licenses from AnaptysBio.
The FDA on Monday approved Jemperli plus carboplatin and
paclitaxel, or chemotherapy, for the treatment of adult patients
with mismatch repair deficient/microsatellite instability-high
primary advanced or recurrent endometrial cancer.
AnaptysBio shares hit their 52-week low of $16.66 on Thursday,
and are down 9% in the past 12 months.
The supplemental Biologics License Application supporting this
new indication received Priority Review and was approved ahead of
the Sept. 23 Prescription Drug User Fee Act action date.
The dual-primary endpoints in Part 1 of the trial are
investigator-assessed progression-free survival and overall
survival.
Jemperli was discovered by AnaptysBio and licensed to Tesaro,
now a part of the GSK group of companies, under a collaboration and
exclusive license agreement signed in March 2014. GSK is
responsible for the ongoing development and commercialization of
Jemperli. AnaptysBio is entitled to receive milestones and tiered
royalties of 8% for net sales of Jemperli below $1 billion and 12%
up to 25% of sales above $1 billion.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 31, 2023 14:12 ET (18:12 GMT)
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