Mesoblast ADSs Plunge Premarket on Latest FDA Rejection
04 Agosto 2023 - 10:03AM
Dow Jones News
By Colin Kellaher
American depositary shares of Mesoblast plummeted more than 65%
in premarket trading Friday after the biopharmaceutical company's
latest setback in its bid to win U.S. Food and Drug Administration
approval for its proposed drug for graft-versus-host disease.
The Melbourne, Australia, company, which was again seeking FDA
approval of remestemcel-L for the treatment of children with
steroid-refractory acute graft-versus-host disease, a potentially
life-threatening complication of an allogeneic bone-marrow
transplant for blood cancer, late Thursday said the FDA issued a
so-called complete response letter, indicating the agency won't
approve the application in its current form.
Mesoblast said the FDA requested more data to support marketing
approval, and that it plans to conduct a targeted, controlled study
in the highest-risk adults with the greatest mortality in order to
obtain the data.
Mesoblast said the new study is in line with its commercial
strategy that envisions a sequenced progression from pediatric to
adult indications, adding that adults comprise 80% of the market
for the targeted indication.
The FDA in 2020 turned away Mesoblast's initial application and
called on the company to conduct another study, even though an FDA
advisory committee had recommended approval of the drug. The FDA
usually follows the advice of its advisory committees.
Mesoblast earlier this year resubmitted its application with new
information requested by the FDA, and the agency in March accepted
the application and set a target action date of Aug. 2.
Trading in Mesoblast ADSs was halted after the close on Aug. 1,
ahead of the FDA's decision. Trading resumed premarket on Friday,
and Mesoblast ADSs were recently down 61% to $1.56.
The company's Australia-listed shares plunged 57% to end
Friday's session at 47 Australian cents.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 04, 2023 08:48 ET (12:48 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Mesoblast (ASX:MSB)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Mesoblast (ASX:MSB)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024