Welcome to our dedicated page for Coherus BioSciences news (Ticker: CHRS), a resource for investors and traders seeking the latest updates and insights on Coherus BioSciences stock.
Coherus BioSciences, Inc. (NASDAQ: CHRS) is a leading commercial-stage biopharmaceutical company dedicated to improving patient access to high-quality, life-changing biologic medicines. Established in 2010 and headquartered in the San Francisco Bay Area, Coherus specializes in developing biosimilars and innovative immuno-oncology therapies to treat various chronic and life-threatening diseases.
Coherus' core business revolves around providing biosimilar therapeutics that are designed to replace existing branded biologics, thereby reducing healthcare costs. The company's biosimilar portfolio includes FDA-approved products like UDENYCA® (a biosimilar to Neulasta®) and YUSIMRY® (a biosimilar to Humira®), which is set to launch in the US in 2023. These products help manage conditions such as cancer and autoimmune diseases, expanding patient access to essential treatments.
Recently, Coherus completed the divestiture of its ophthalmology franchise, CIMERLI®, to Sandoz, Inc. for $170 million. This move allows Coherus to focus more intently on its immuno-oncology pipeline, which includes the promotion of LOQTORZI™ (toripalimab-tpzi), a next-generation PD-1 inhibitor approved for nasopharyngeal carcinoma. The company's strategy includes advancing its novel immuno-oncology candidates like CHS-114 and CHS-1000, which are in various stages of clinical development targeting solid tumors.
Financially, Coherus is leveraging the revenue from its biosimilar products to fund its immuno-oncology research and development. The company collaborates with global pharmaceutical partners across Europe, Asia, and Latin America, enhancing its market presence and resource capabilities.
Key updates include the successful preclinical data presentation for CHS-1000 at the 2024 AACR Annual Meeting, showcasing its potential to reverse immunosuppression in the tumor microenvironment. Moreover, the Cancer Research Institute (CRI) has selected LOQTORZI for combination studies to explore its efficacy in drug-resistant cancers, further solidifying Coherus' commitment to pioneering cancer therapy advancements.
Led by a team of seasoned industry veterans, Coherus BioSciences aims to become a global leader in the biosimilar and immuno-oncology markets, continually striving to develop therapies that improve patient outcomes and broaden access to high-quality medical treatments.
The FDA has accepted Coherus BioSciences' Biologics License Application (BLA) for toripalimab, an anti-PD-1 monoclonal antibody, for treating nasopharyngeal carcinoma (NPC). This BLA, which includes toripalimab with chemotherapy and as monotherapy, has been granted Priority Review, with a target action date of April 2022. Coherus aims to establish a new treatment standard for NPC, an aggressive cancer lacking FDA-approved immuno-oncology options. The development is supported by pivotal clinical studies POLARIS-02 and JUPITER-02.
Coherus BioSciences (Nasdaq: CHRS) will announce its third-quarter 2021 financial results after the market closes on November 8, 2021. A conference call and webcast will follow at 5 p.m. ET, where management will discuss the results and provide a business update. Investors can access the financial results via the company's website after the announcement. Additionally, the conference call can be joined through specified dial-in numbers and a conference ID. Coherus aims to enhance access to cost-effective medicines for impactful patient care.
Coherus BioSciences (Nasdaq: CHRS) announced the unexpected passing of board member Alan C. Mendelson, who had been a director since January 2021. Mendelson was a prominent figure in the biotech industry, previously serving as external legal counsel since the company’s inception in 2010. CEO Denny Lanfear praised Mendelson's immense contributions to the company and the industry. Mendelson's extensive legal career included significant roles at Latham & Watkins LLP and Cooley LLP, advising multiple biotech firms. His loss is felt deeply across various sectors.
Coherus BioSciences (CHRS) announced positive results from a clinical trial evaluating its proposed UDENYCA® On-Body Injector (OBI). The trial demonstrated pharmacokinetic and pharmacodynamic bioequivalence with the current UDENYCA® pre-filled syringe. Enrolled were 189 subjects, and the study met all primary endpoints with no new safety concerns. Coherus plans to seek FDA marketing authorization in 2022 and expects a commercial launch shortly after approval, positioning itself to compete with Neulasta® Onpro®, which holds over 50% market share in pegfilgrastim delivery.
Coherus BioSciences announced positive results from the pivotal COLUMBUS-AMD trial, comparing the efficacy and safety of CHS-201 against Lucentis® in treating wet age-related macular degeneration. Results showed equivalent clinical efficacy and safety between both treatments in a cohort of 477 patients. If approved, CHS-201 could be marketed in the U.S. in late 2022, following the acceptance of its biologics license application by the FDA. The trial's primary endpoint was met, demonstrating significant visual acuity improvement for both treatments.
Coherus BioSciences (CHRS) announced that the FDA has accepted its 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar of Lucentis. The FDA's target action date is set for August 2, 2022. If approved, Coherus plans to launch CHS-201 in the U.S. in the second half of 2022. The BLA was submitted by Coherus’ partner Bioeq AG, from whom they acquired U.S. commercial rights in 2019. Coherus also anticipates future launches of additional biosimilars, building on their successful biosimilar commercialization track record.
Coherus BioSciences (Nasdaq: CHRS) has announced the passing of board member Dr. Samuel Nussbaum, who served since May 2018. Dr. Nussbaum was a prominent healthcare executive and physician with significant contributions to the industry. His leadership was valued by Coherus, and CEO Denny Lanfear expressed deep gratitude for his service. Dr. Nussbaum previously held executive roles at Anthem and had a distinguished career in medicine and research, including a tenure at Harvard Medical School. His absence will be felt across the organization.
Coherus BioSciences, Inc. (Nasdaq: CHRS) announced on Sept. 24, 2021, that it granted options to purchase 229,500 shares of common stock to newly hired employees, effective Sept. 22, 2021. The options have an exercise price of $17.06, matching the closing trading price on the grant date. Among the recipients, a new Senior Vice President received options for 100,000 shares. These grants were made under the Coherus BioSciences 2016 Employment Commencement Incentive Plan, approved to attract new talent.
Coherus BioSciences (CHRS) and Junshi Biosciences announced positive interim results from the Phase 3 JUPITER-06 trial on toripalimab combined with chemotherapy for advanced esophageal squamous cell carcinoma (ESCC). The study demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone, meeting co-primary endpoints. The companies plan to submit a Biologics License Application (BLA) supplement in 2022 to expedite toripalimab's availability for ESCC patients in the U.S. Full data will be presented at the ESMO Congress on September 17, 2021.
Coherus BioSciences (Nasdaq: CHRS) and Shanghai Junshi Biosciences announced significant findings from the JUPITER-02 clinical trial, published in Nature Medicine. The Phase 3 trial demonstrated that toripalimab combined with standard chemotherapy improved progression-free survival (PFS) in patients with advanced nasopharyngeal carcinoma (NPC), showing a median PFS of 11.7 months versus 8.0 months with chemotherapy alone. While overall survival data is not yet mature, a 40% reduction in death risk was noted. A biologics license application has been submitted to the FDA for approval.
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