Coherus (CHRS) Stock Rallies on FDA Nod for Udenyca Onbody
Shares of Coherus BioSciences, Inc. CHRS were up 23.4% on Dec 27 after the company announced that the FDA has approved Udenyca Onbody, the on-body injector presentation of Udenyca (pegfilgrastim-cbqv).
Udenyca is a biosimilar of Amgen’s AMGN 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.
AMGN also markets Neulasta Onpro injector, which is an on-body injector of its drug, Neulasta.
CHRS expects to commercially launch Udenyca Onbody in the United States in the first quarter of 2024. The innovative design for Udenyca Onbody is likely to help cancer patients with a five-minute injection time.
Per the company, the latest FDA approval for Udenyca Onbody was based on comprehensive analytical and clinical data, including pharmacokinetic and pharmacodynamic bioequivalence data, as well as adhesive performance and tolerability data.
Shares of Coherus have plunged 63% in the past year compared with the industry’s decline of 15%.
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In October 2023, Coherus resubmitted the biologics license application (BLA) supplement for Udenyca Onbody to the FDA. The resubmission followed the successful completion and satisfactory resolution of the FDA’s review of inspection findings at a third-party filler.
We remind investors that the regulatory body had issued a complete response letter (CRL) to the BLA supplement for Udenyca Onbody in September.
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, study design, labeling, drug substance manufacturing or device design and manufacturing related to Udenyca Onbody.
Also, the FDA did not request any additional data or study for the same.
Zacks Rank & Stocks to Consider
Coherus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have rallied 19.6%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 56 cents to 64 cents. In the past year, shares of PBYI have gained 4.3%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining one occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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