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.
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.
Coherus BioSciences (Nasdaq: CHRS) announced participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 10:00 am ET. Senior management will engage in a fireside chat, which will be available via an audio webcast on the company's investor page. Interested parties are encouraged to access the webcast in advance to ensure a timely connection. The archived webcast will be accessible on the Coherus website for 30 days following the event.
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