Welcome to our dedicated page for Coherus Bioscien news (Ticker: CHRS), a resource for investors and traders seeking the latest updates and insights on Coherus Bioscien stock.
Coherus BioSciences (NASDAQ: CHRS) is a commercial-stage biopharmaceutical company advancing innovative oncology therapies, including immunotherapies and biosimilars. This page provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives shaping cancer care.
Discover comprehensive coverage of CHRS news, including FDA approvals, partnership announcements, and pipeline advancements. Our curated updates ensure you stay informed about the company activities that matter most—from late-stage clinical trials to commercialization strategies for oncology biosimilars.
Key focus areas include updates on immuno-oncology candidates targeting tumor microenvironments, progress in expanding global biosimilar access, and analyses of strategic collaborations. All content is verified for accuracy and relevance to support informed decision-making.
Bookmark this page for direct access to Coherus BioSciences' latest press releases and news. Check back regularly for authoritative insights into one of oncology’s most dynamic innovators.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced positive results from the final overall survival analysis of the JUPITER-02 trial.
The study evaluated the combination of toripalimab with chemotherapy in patients with advanced nasopharyngeal carcinoma (NPC), showing a statistically significant improvement in overall survival compared to chemotherapy alone.
The FDA has granted Breakthrough Therapy designation for toripalimab's use in this indication, underscoring its potential as a new standard-of-care treatment for NPC once approved.
Coherus BioSciences announced a significant milestone for its biosimilar CIMERLI®, as the Centers for Medicare and Medicaid Services assigned a Healthcare Common Procedure Coding System (HCPCS) Q-code effective April 1, 2023. This Q-code will enhance billing efficiency and reimbursement speed for healthcare providers. Paul Reider, Chief Commercial Officer, indicated that this development could catalyze market conversion and growth for CIMERLI® in 2023. CIMERLI® is the only FDA-approved interchangeable biosimilar of Lucentis®, indicated for various ocular diseases, making it a vital addition to Coherus' portfolio.
Coherus BioSciences announced the grant of stock options on February 1, 2023, to three new employees, totaling 22,500 shares. The exercise price for these options is set at $8.65, equal to the closing stock price on the grant date. This initiative is part of the 2016 Employment Commencement Incentive Plan, designed to attract and retain talent within the company. The plan was approved under Nasdaq regulations, emphasizing Coherus's commitment to strengthening its workforce and enhancing operational capacity.
Coherus BioSciences has signed a binding term sheet with Klinge Biopharma for exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea®, in the U.S. The deal involves a total upfront payment of approximately €30 million and includes milestone payments and profit-sharing. Coherus plans to file a Biologics License Application with the FDA in 2023 and aims to launch FYB203 by 2025 if approved. This expansion targets the $7 billion anti-VEGF market, enhancing Coherus' portfolio and growth potential.
Coherus BioSciences (Nasdaq: CHRS) announced that senior management will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 8:15 a.m. PT. The presentation will include a Q&A session and can be accessed via webcast, available for replay until February 10, 2023. As a commercial-stage biopharmaceutical company, Coherus focuses on innovative immunotherapies for cancer treatment and has a portfolio of FDA-approved therapeutics.
The FDA has delayed its review of Coherus BioSciences' Biologics License Application (BLA) for toripalimab due to travel restrictions in China preventing necessary site inspections. The application was not acted upon by the December 23, 2022 PDUFA date. Coherus and Junshi Biosciences are in discussions with the FDA to expedite the inspection process. Toripalimab is intended for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC), a condition with significant unmet medical needs. The FDA has awarded Priority Review and Breakthrough Therapy designations to toripalimab.
Coherus BioSciences (Nasdaq: CHRS) reported Q3 2022 net sales of $45.4 million, a decline from $82.5 million in Q3 2021. This drop stemmed from reduced sales volume of UDENYCA® and lower prices amid increased competition. The FDA approved CIMERLI™ in August 2022, which launched on October 3, 2022, and is projected to generate over $100 million in 2023 sales. Coherus anticipates the launch of several new products in 2023 and is targeting profitability by 2024. The net loss for Q3 was $86.7 million, up from a $38.5 million loss in the same quarter last year.
Coherus BioSciences (CHRS) has announced its third quarter 2022 financial results will be released on November 8, 2022, after market close. Following the release, management will host a conference call at 5:00 p.m. Eastern Time to discuss the results and provide a business update. Investors can access the press release and related materials on the official website before the call. A replay of the webcast will be available post-call. Pre-registration is required for call access, ensuring a timely connection.
Coherus BioSciences and Junshi Biosciences announced significant improvements in overall survival (OS) and progression-free survival (PFS) in their phase 3 trial of toripalimab combined with chemotherapy for treatment-naïve advanced non-small cell lung cancer (NSCLC) without EGFR/ALK mutations. The trial showed a median PFS of 8.4 months compared to 5.6 months for chemotherapy alone, and a 2-year OS rate of 51.2% versus 33.9%. No new safety concerns were reported. This data supports further development of toripalimab in combination with other immunotherapies.
CIMERLI is the first FDA-approved biosimilar interchangeable with Lucentis for all indications, with a 12-month exclusivity on interchangeability. Launching on October 3, 2022, it offers the same efficacy and safety as Lucentis, allowing for confident transitions for existing patients. The product is priced at $1,360 for the 0.5 mg dose, providing a 30% discount compared to Lucentis. Coherus aims to capture a significant market share by leveraging its dedicated sales team and CIMERLI Solutions™ for patient support and reimbursement.
