Maxim Group raised its price target for Coherus Biosciences (NASDAQ:CHRS) to $22 from $18 after the FDA has accepted for review the recently resubmitted BLA for CHS-1701 (Neulasta biosimilar).
This is a Type I response related to the complete response letter (CRL) received last year. The BSUFA, or Biosimilar User Fee Act, date is Nov. 3. “We have removed our risk adjustment of 15% in our model, which raises our price target to $22, from $18,” writes analyst Jason McCarthy.
The CRL last year was related to manufacturing documentation-related issues as well as the FDA requesting retesting of a segment of patient samples for immunogenicity, he added.
Mr. McCarthy said Coherus is not alone and that’s important for investors to be aware of because Neulasta has proven a challenging biosimilar to make. “Three competitors also received CRLs, though as opposed to Coherus, these CRLs were related to manufacturing and clinical trials. Coherus has resubmitted and could be first to approval/launch in the U.S.”
Mr. McCarthy said Coherus is continuing to make progress building CHS-1701 inventory as the company prepares to transform from a clinical to commercial entity.
