Shares of commercial-stage biopharmaceutical company
Coherus BioSciences, Inc. ( CHRS Quick Quote CHRS - Free Report) were down 9.2% on receipt of a complete response letter (CRL) from the FDA regarding the biologics license application (BLA) supplement for Udenyca Onbody.
Coherus markets Udenyca (pegfilgrastim-cbqv), a biosimilar of
Amgen’s ( AMGN Quick Quote AMGN - Free Report) Neulasta. Udenyca Onbody is the company's on-body injector presentation of Udenyca.
The CRL was issued only due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing or device design and manufacturing. No additional data or trials have been requested by the regulatory body.
Amgen’s Neulasta is indicated for use in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment.
Concurrently, Coherus announced that the FDA completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two clinical trials supporting the BLA for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma as first-line treatment or as second- or greater-line treatment.
Post-inspection, only one site received an FDA Form 483, with one observation noted. Coherus expects to resolve the shortcoming soon and continues to anticipate potential approval for toripalimab by 2023-end.
Shares of Coherus have plunged 48.8% in the year so far compared with the
industry’s decline of 16.2%. Image Source: Zacks Investment Research
Shares of the company declined earlier in the month after it was removed from a small-cap equity index.
We remind investors that Coherus is developing toripalimab, an anti-PD-1 antibody, in the United States and Canada through an in-licensing agreement with Shanghai Junshi Biosciences Ltd. A BLA for toripalimab for treating nasopharyngeal carcinoma is under review by the FDA. Toripalimab is already approved in China for the treatment of melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer.
Earlier in the month, Coherus acquired Surface Oncology, Inc., a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.
As a result of the acquisition, Coherus’ novel I-O pipeline now includes multiple antibody immunotherapy candidates. These include casdozokitug (SRF388 or casdozo), a novel, first-in-class IL-27-targeted antibody currently being evaluated in phase II studies in lung cancer and liver cancer and CHS-114 (SRF114), a highly selective, competitively positioned, ADCC-enhanced CCR8-targeted antibody currently in a phase I/II study as a monotherapy in patients with advanced solid tumors. It also includes CHS-006, a TIGIT-targeted antibody currently in a phase I/II study in combination with toripalimab in patients with advanced solid tumors.
Apart from Neulasta, Coherus is marketing Cimerli (ranibizumab-eqrn), a biosimilar of Lucentis and Yusimry (adalimumab-aqvh), a biosimilar of Humira.
Zacks Rank and Stocks to Consider
Coherus currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are
Eton Pharmaceuticals ( ETON Quick Quote ETON - Free Report) and Dynavax Technologies ( DVAX Quick Quote DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.