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.
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