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Coherus (CHRS) Stock Rises on BLA Re-Filing for Udenyca Onbody
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Coherus BioSciences, Inc. (CHRS - Free Report) shares were up 8.1% on Friday after the company announced that it has resubmitted the biologics license application (BLA) supplement for Udenyca Onbody to the FDA.
Udenyca Onbody is the company's on-body injector presentation of Udenyca. Coherus markets Udenyca (pegfilgrastim-cbqv), which is a biosimilar of Amgen’s (AMGN - Free Report) Neulasta.
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.
Amgen also markets Neulasta Onpro injector, which is an on-body injector of its drug, Neulasta.
The news comes as a major boost for Coherus, especially after the FDA issued a complete response letter (CRL) to the BLA supplement for Udenyca Onbody, last month.
Though the CRL was issued only due to an ongoing review of inspection findings at a third-party filler, it did not identify any issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing or device design and manufacturing related to Udenyca Onbody. Also, the FDA did not request any additional data or trial for it.
The above resubmission of the BLA supplement for Udenyca Onbody comes after the successful completion and satisfactory resolution of the FDA’s review of inspection findings at a third-party filler.
Coherus is expecting a potential approval of the BLA supplement for Udenyca Onbody later in the ongoing year.
Shares of Coherus have lost 52.7% so far this year compared with the industry’s decline of 16.5%.
Image Source: Zacks Investment Research
We note that Coherus is also 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.
In September 2023, 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.
Coherus expects a potential approval for toripalimab by 2023-end.
Toripalimab is presently approved for the treatment of various types of cancer indications such as melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer in China.
Loss per share estimates for Sarepta have narrowed 5.5% for 2023 and 39.7% for 2024 in the past 60 days.
Earnings of Sarepta surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. SRPT witnessed a negative earnings surprise of 5.15% on average.
Loss per share estimates for Annovis Bio have narrowed 10.4% for 2023 and 12.9% for 2024 in the past 60 days.
Earnings of Annovis Bio surpassed estimates in three of the trailing four quarters and missed on the other occasion. ANVS witnessed an earnings surprise of 13.40% on average.
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Coherus (CHRS) Stock Rises on BLA Re-Filing for Udenyca Onbody
Coherus BioSciences, Inc. (CHRS - Free Report) shares were up 8.1% on Friday after the company announced that it has resubmitted the biologics license application (BLA) supplement for Udenyca Onbody to the FDA.
Udenyca Onbody is the company's on-body injector presentation of Udenyca. Coherus markets Udenyca (pegfilgrastim-cbqv), which is a biosimilar of Amgen’s (AMGN - Free Report) Neulasta.
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.
Amgen also markets Neulasta Onpro injector, which is an on-body injector of its drug, Neulasta.
The news comes as a major boost for Coherus, especially after the FDA issued a complete response letter (CRL) to the BLA supplement for Udenyca Onbody, last month.
Though the CRL was issued only due to an ongoing review of inspection findings at a third-party filler, it did not identify any issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing or device design and manufacturing related to Udenyca Onbody. Also, the FDA did not request any additional data or trial for it.
The above resubmission of the BLA supplement for Udenyca Onbody comes after the successful completion and satisfactory resolution of the FDA’s review of inspection findings at a third-party filler.
Coherus is expecting a potential approval of the BLA supplement for Udenyca Onbody later in the ongoing year.
Shares of Coherus have lost 52.7% so far this year compared with the industry’s decline of 16.5%.
Image Source: Zacks Investment Research
We note that Coherus is also 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.
In September 2023, 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.
Coherus expects a potential approval for toripalimab by 2023-end.
Toripalimab is presently approved for the treatment of various types of cancer indications such as melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer in China.
Coherus BioSciences, Inc. Price
Coherus BioSciences, Inc. price | Coherus BioSciences, Inc. Quote
Zacks Rank and Stocks to Consider
Coherus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Sarepta Therapeutics, Inc. (SRPT - Free Report) and Annovis Bio, Inc. (ANVS - Free Report) . While Sarepta sports a Zacks Rank #1 (Strong Buy), Annovis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Sarepta have narrowed 5.5% for 2023 and 39.7% for 2024 in the past 60 days.
Earnings of Sarepta surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. SRPT witnessed a negative earnings surprise of 5.15% on average.
Loss per share estimates for Annovis Bio have narrowed 10.4% for 2023 and 12.9% for 2024 in the past 60 days.
Earnings of Annovis Bio surpassed estimates in three of the trailing four quarters and missed on the other occasion. ANVS witnessed an earnings surprise of 13.40% on average.