공시 • Feb 22

Coherus BioSciences, Inc. Announces U.S. Launch of UDENYCA ONBODY a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv

Coherus BioSciences, Inc. announced the launch of UDENYCA ONBODY, the company's on-body injector (OBI) presentation of UDENYCA (pegfilgrastim-cbqv), is successfully underway, with a broad distribution of accounts nationwide ordering this innovative device, and patients now accessing its benefits. UDENYCA is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. UDENYCA ONBODY was designed with patients in mind; key features include a five-minute injection time, an indicator, status light and auditory signal that help patients confirm the dose has been administered and a strong and well-tolerated adhesive. After the dose is administered, the needle automatically retracts, which reduces the risk of needlestick injury. UDENYCA ONBODY is available through existing full-line and specialty distributors. Billing under the medical benefit for UDENYCA ONBODY is streamlined because it has the same permanent, product-specific Q-Code as the prefilled syringe, Q5111, and a unique NDC number of 70114-0130-01. UDENYCA Solutions™ offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance and office support to ensure successful access, billing, and reimbursement. More details regarding UDENYCA ONBODY, including video instructions for ONBODY preparation and application. UDENYCA is the only pegfilgrastim brand approved in the United States available in three administration options—prefilled syringe (PFS), autoinjector (AI) and on-body injector—providing patients and healthcare providers with choice, control, and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA. INDICATION UDENYCA is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis. WARNINGS AND PRECAUTIONS: Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA® in patients with ARDS. Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA® in patients with serious allergic reactions. Allergies to Acrylics: The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA® if sickle cell crisis occurs. Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA® if causality is likely. Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA® therapy is recommended. Thrombocytopenia: hrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts. Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care. Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings. Potential Device failures: Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended. Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected. Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

공시 • Oct 16

Coherus BioSciences, Inc. Announces Toripalimab Data at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Coherus BioSciences, Inc. announced a presentation of toripalimab data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 11-15, 2023 at the Hynes Convention Center in Boston. PD-L1, a protein found on the surface of some cancer cells, suppresses T cell activation and inhibits the ability of the body’s immune system to kill cancer cells. Toripalimab is an anti-PD-1 monoclonal antibody that binds with high affinity to a unique site on PD-1, thereby blocking the interaction of PD-1 and PD-L1. Preclinical mechanistic data demonstrate statistically significantly higher activation of T cells and higher expression of key immune system activators with toripalimab compared to pembrolizumab, clinically a widely used anti-PD-1 monoclonal antibody for the treatment of cancer patients. These data may provide a mechanistic explanation for the improvements in overall survival irrespective of PD-L1 expression levels observed in clinical trials in multiple tumor types evaluating toripalimab in combination with chemotherapy. A biologics license application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) is currently under review by the U.S. Food and Drug Administration (FDA). Poster presentation data are summarized as follows: Toripalimab in combination with chemotherapy significantly improved overall survival irrespective of PD-L1 status in post hoc analyses of 3 randomized controlled clinical trials, including in NPC, non-small cell lung cancer (NSCLC) and esophageal squamous-cell carcinoma (ESCC). Toripalimab exhibits a 12-fold higher binding affinity for PD-1 compared to pembrolizumab that is driven by a slow-off rate. Toripalimab is more potent than pembrolizumab in enhancing levels of Th1 cytokines and cytotoxicity in human peripheral blood mononuclear cells (PBMCs). In comparison to pembrolizumab, binding of toripalimab to PD-1 induced low levels of SHP1 and SHP2 recruitment, thereby minimizing a key process of T cell suppression. Toripalimab induced and elevated IFN-y gene signature in NSCLC dissociated tumor cells with different kinetics and intensity compared to pembrolizumab. Toripalimab is a next-generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD?-?1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types. The BLA for toripalimab in combination with chemotherapy as the first-line treatment for recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the FDA. In Europe, the marketing authorization applications (MAA) for toripalimab for the first-line treatment of NPC and esophageal squamous cell carcinoma (ESCC) are under review by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of ESCC, NPC, mucosal melanoma, soft tissue sarcoma, and small-cell lung cancer (SCLC). More than 40 company-sponsored toripalimab clinical studies covering over fifteen indications have been conducted globally by Shanghai Junshi Biosciences Co. Ltd. (Junshi Biosciences), including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology. Through an in-licensing agreement with Junshi Biosciences, Coherus is developing toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of NPC is under review by the FDA. Toripalimab is approved in China for the treatment of melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer. Through its recent acquisition of Surface Oncology, Coherus’ immuno-oncology pipeline now includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug (formerly SRF388) is a novel anti-IL-27 antibody currently being evaluated in Phase 1/2 clinical trials in lung and liver cancer. CHS-114 (formerly SRF114) is a highly selective, competitively positioned anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. There are also two out-licensed partnership programs to advance its next-generation cancer therapies. Coherus’ earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms in the tumor microenvironment, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with toripalimab in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.

총 주주 수익률	-25.5%
미래 배당 수익률	0%
배당 성장률	n/a
다음 배당 지급일	n/a
배당락일	n/a
주당 배당금	n/a
배당 성향	n/a

구분	배당 수익률
회사 (CHRS)	n/a
시장 하위 25% (US)	1.4%
시장 상위 25% (US)	4.2%
업계 평균 (Biotechs)	2.4%
분석가 예측 (CHRS) (최대 3년)	0%

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/05/22 06:30
종가	2026/05/22 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Colleen Kusy	Baird
Balaji Prasad	Barclays
Balaji Prasad	Barclays

Coherus Oncology 배당 및 자사주 매입

배당 기준 점검 0/6

핵심 정보

최근 배당 및 자사주 매입 업데이트

Recent updates

Price target increased by 67% to US$7.80

Consensus revenue estimates decrease by 10%

CHRS: Anti Tumor Readouts Will Shape Future Revenue Visibility And Profitability

Coherus Oncology, Inc. to Report Q1, 2026 Results on May 11, 2026

CHRS: Lock Ups And Recent Equity Raise Will Shape Bullish Outlook

CHRS: Upcoming Readouts And New Outperform Coverage Will Shape Oncology Upside

Coherus Oncology, Inc., Annual General Meeting, May 27, 2026

CHRS: Upcoming Readouts And Equity Raises Will Shape Oncology Outlook

CHRS: Upcoming Readouts And Biomarker Data Will Support Stronger Oncology Outlook

CHRS: Upcoming Readouts And New Collaboration Will Shape Oncology Pipeline Outlook

Coherus Oncology, Inc. to Report Q4, 2025 Results on Mar 09, 2026

Coherus: Downgrade To 'Hold' On Potential Advancement Of Anti-CCR8 CHS-114

CHRS: Upcoming Clinical Readouts Will Drive Reassessment Of Oncology Pipeline Potential

Coherus Oncology, Inc. has filed a Follow-on Equity Offering.

Coherus Oncology, Inc. Announces Clinical Supply Agreement with Janssen Research & Development, LLC

CHRS: Upcoming Readouts Will Shape Revenue Visibility And Profitability Expectations

Coherus Oncology, Inc. has filed a Follow-on Equity Offering in the amount of $64.880054 million.

CHRS: Future Biomarker And Index Inclusion Catalysts Will Support Stronger Oncology Outlook

There's No Escaping Coherus Oncology, Inc.'s (NASDAQ:CHRS) Muted Revenues Despite A 27% Share Price Rise

CHRS: Future Immune Activation And Biomarker Data Will Support Stronger Oncology Outlook

Coherus Oncology, Inc. Announces Publication in Molecular Cancer Therapeutics Highlighting the Strong Pharmacology of Investigational Ccr8 Antibody Tagmokitug (Chs-114)

CHRS: Future Immune Activation Data Will Support Stronger Oncology Outlook

Revenues Working Against Coherus Oncology, Inc.'s (NASDAQ:CHRS) Share Price Following 26% Dive

Coherus Oncology, Inc. Presents at SITC Clinical Multiomic Biomarker Data for CHS-114, Highly Selective Anti-CCR8 Cytolytic Antibody

Coherus Oncology, Inc. to Report Q3, 2025 Results on Nov 06, 2025

Upcoming Clinical Data Will Reshape Immuno-Oncology Amid Uncertainties

Industry Analysts Just Upgraded Their Coherus Oncology, Inc. (NASDAQ:CHRS) Revenue Forecasts By 21%

Coherus Oncology, Inc. to Report Q2, 2025 Results on Aug 07, 2025

Coherus Oncology, Inc.'s (NASDAQ:CHRS) Price Is Right But Growth Is Lacking After Shares Rocket 35%

Coherus Oncology Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement

Storm Therapeutics Announces First Patient Dosed in Clinical Collaboration to Evaluate Stc-15 in Combination with Loqtorzi®?

Coherus BioSciences, Inc.'s (NASDAQ:CHRS) 32% Dip In Price Shows Sentiment Is Matching Revenues

Some Coherus BioSciences, Inc. (NASDAQ:CHRS) Analysts Just Made A Major Cut To Next Year's Estimates

Coherus BioSciences, Inc. to Report Q1, 2025 Results on May 12, 2025

Coherus BioSciences, Inc., Annual General Meeting, Jun 11, 2025

Coherus Presents Early Clinical Data from Phase 1 Dose Expansion Study of CHS-114 in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma At AACR 2025

Coherus BioSciences: Cleaning The Balance Sheet And Developing New Drugs

UDENYCA Divestiture And LOQTORZI Progress Will Forge Opportunity Amid Risks

Lacklustre Performance Is Driving Coherus BioSciences, Inc.'s (NASDAQ:CHRS) 27% Price Drop

Shareholders Shouldn’t Be Too Comfortable With Coherus BioSciences' (NASDAQ:CHRS) Strong Earnings

Coherus BioSciences, Inc. to Report Q4, 2024 Results on Mar 10, 2025

Coherus BioSciences, Inc. Presents Final Phase 2 Clinical Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

There's No Escaping Coherus BioSciences, Inc.'s (NASDAQ:CHRS) Muted Revenues Despite A 38% Share Price Rise

Coherus to Present Final Phase 2 Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carinoma at ASCO-GI 2025

Coherus BioSciences: Shedding Pegfilgrastim To Fuel Ongoing Development

Intas Pharmaceuticals Limited entered into asset purchase agreement to acquire UDENYCA Franchise of Coherus BioSciences, Inc. (NasdaqGM:CHRS) for $560 million.

Investors Don't See Light At End Of Coherus BioSciences, Inc.'s (NASDAQ:CHRS) Tunnel And Push Stock Down 30%

Coherus BioSciences, Inc. to Report Q3, 2024 Results on Nov 06, 2024

Revenues Working Against Coherus BioSciences, Inc.'s (NASDAQ:CHRS) Share Price Following 27% Dive

Evaluating Coherus BioSciences: Udenyca's Success And Loqtorzi's Prospects

Why Investors Shouldn't Be Surprised By Coherus BioSciences, Inc.'s (NASDAQ:CHRS) Low P/S

Coherus BioSciences, Inc. to Report Q2, 2024 Results on Aug 08, 2024

Coherus BioSciences, Inc. Appoints Rita Karachun to Its Board of Directors

Coherus BioSciences: CHS-114 Comes Into View At ASCO, Drug Launches Underway

Coherus Biosciences, Inc. Presents Preliminary Results from Phase I Dose Escalation Study of its Anti-Chemokine Receptor 8 (CCR8) Antibody, CHS-114, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Shareholders May Be More Conservative With Coherus BioSciences, Inc.'s (NASDAQ:CHRS) CEO Compensation For Now

Forecast breakeven date moved forward to 2024

First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind

Coherus BioSciences, Inc. announced that it has received $38.7 million in funding

Coherus BioSciences, Inc. Announces Clinical Collaboration with the Cancer Research Institute for a Novel Combination Evaluating LOQTORZI®? (toripalimab-tpzi) with ENB-003 for the Treatment of Ovarian Cancer

Coherus BioSciences, Inc. to Report Q1, 2024 Results on May 09, 2024

Coherus BioSciences, Inc. Announces Presentation of Clinical Data for CHS-114 at 2024 American Society of Clinical Oncology Annual Meeting

Coherus BioSciences, Inc., Annual General Meeting, May 29, 2024

Consensus EPS estimates upgraded to US$0.55 loss, revenue downgraded

Coherus Biosciences: Dumping One Drug But Showing Promise With Another

Forecast breakeven date pushed back to 2026

Coherus BioSciences, Inc. to Report Q4, 2023 Results on Mar 13, 2024

New major risk - Financial position

Coherus BioSciences, Inc. Announces U.S. Launch of UDENYCA ONBODY a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv

Lead Independent Director exercised options to buy US$139k worth of stock.

Revenues Working Against Coherus BioSciences, Inc.'s (NASDAQ:CHRS) Share Price Following 29% Dive

Sandoz Group AG (SWX:SDZ) entered into a definitive agreement to acquire CIMERLI an ophthalmology franchise from Coherus BioSciences, Inc. (NasdaqGM:CHRS) for approximately $170 million.

Coherus BioSciences, Inc. Presents Positive Phase 2 Clinical Data on Casdozokitug, A First-In-Class IL-27-Targeted Antibody, At the 2024 ASCO GI Cancers Symposium

Coherus BioSciences: FDA Approvals Spice Up The Pipeline

Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv