Coherus Up; Gets FDA Complete Response Letter, But New Clinical Data Not Needed
May 02 2022 - 3:43PM
Dow Jones News
By Michael Dabaie
Coherus BioSciences Inc. shares were higher Monday after it and
Shanghai Junshi Biosciences Co. Ltd. said they received a U.S. Food
and Drug Administration complete response letter, but more clinical
data won't be needed.
The companies said they received the letter, which indicates the
agency won't approve an application in its current form, for
toripalimab in combination with gemcitabine and cisplatin in the
first-line treatment of nasopharyngeal carcinoma and toripalimab
monotherapy in the second-line or later treatment of NPC.
Coherus shares were up 3.3% at $9.34 after trading in negative
territory earlier in the session.
Coherus said it is working close with partner Junshi Biosciences
to facilitate the completion of the FDA's review and in late April,
responded quickly to an FDA request for a quality process change
and implemented required actions.
"The FDA has indicated that the existing toripalimab clinical
data are supportive of the BLA submission," said Coherus Chief
Executive Denny Lanfear.
Coherus and Junshi said they plan to meet with the FDA directly
and expect to resubmit the application by mid-summer 2022.
Mizuho Securities USA analyst Salim Syed said in a note that
said it got more information on the letter from company
management.
"The requested quality process change doesn't relate to how the
product is made, and its implementation should be addressable.
Importantly, no additional clinical data was requested. With onsite
inspections in China expected to take place during 2H of the year,
management is shooting for a potential end-of-the-year approval,"
Mizuho analyst write.
The Mizuho said Monday's news represents a short-term
hurdle.
The FDA not requiring any additional clinical data "implicitly
may be validating the potential approvability of the submitted
clinical data," the analyst note said.
NPC is a type of aggressive cancer that starts in the upper part
of the throat behind the nose and near the base of skull. In 2021,
Coherus in-licensed rights to develop and commercialize toripalimab
in the U.S. and Canada.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
May 02, 2022 15:28 ET (19:28 GMT)
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