Coherus Biosciences Inc (NASDAQ:CHRS) investors are wildly disappointed today following the news that the FDA has issued a complete response letter (CRL) for its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway.
Coherus Biosciences shares reacted to the news, tumbling over 30% to $14.00 in pre-market trading Monday.
The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.
Coherus will work with the FDA to address the information requests.
CEO Denny Lanfear said, “While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” said Denny Lanfear, President and CEO of Coherus BioSciences. “We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months. Neulasta is the largest selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access.”
On the ratings front, Coherus stock has been the subject of a number of recent research reports. In a report issued on May 17, Citigroup analyst Mohit Bansal maintained a Buy rating on CHRS, with a price target of $38, which represents a potential upside of 84% from where the stock is currently trading. Separately, on the same day, Maxim Group’s Jason McCarthy reiterated a Buy rating on the stock and has a price target of $44.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mohit Bansal and Jason McCarthy have a yearly average loss of 14.1% and 12.5% respectively. Bansal has a success rate of 14% and is ranked #4025 out of 4570 analysts, while McCarthy has a success rate of 33% and is ranked #4503.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $54.00 which is 161.5% above where the stock closed last Friday.
Coherus BioSciences, Inc. is a late-stage clinical biologics platform company, which engages in the development and commercializition of biosimilar therapeutics worldwide. It focuses on global biosimilar market.