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 reported Q4 2022 net product sales of $45.4 million and full-year sales of $211.0 million. The FDA plans an inspection of the toripalimab manufacturing site in Q2 2023, with launches of toripalimab and UDENYCA® products anticipated. The UDENYCA® autoinjector received FDA approval, while the on-body injector is under review. The company also plans a reduction in workforce by approximately 60 employees and expects combined R&D and SG&A expenses for 2023 to be $315 to $335 million, reflecting a nearly $100 million reduction from previous guidance. The net loss for Q4 2022 was $58.9 million.
Coherus BioSciences, Inc. (Nasdaq: CHRS) announced FDA approval for the UDENYCA® autoinjector, a pegfilgrastim treatment that reduces infection risks in cancer patients after chemotherapy. This innovative, easy-to-use device allows for both in-clinic and at-home administration, enhancing patient accessibility. The approval is supported by extensive data, and the autoinjector's commercial launch is planned for the second quarter of 2023. Additionally, a proprietary on-body injector is under FDA review, potentially expanding UDENYCA®'s market reach further. Over 263,000 patients have utilized UDENYCA® since its 2019 launch.
Coherus BioSciences (Nasdaq: CHRS) will present at two major investor conferences in March 2023. The first is the 43rd Annual Cowen Health Care Conference on March 7 at 2:10 p.m. ET, followed by the Barclays 2023 Global Healthcare Conference on March 14 at 4:05 p.m. ET. Audio webcasts of these presentations will be accessible on the Coherus investors' page and archived for 30 days. Investors are encouraged to connect to the webcasts promptly.
For inquiries, contact Marek Ciszewski, SVP Investor Relations at IR@coherus.com.
Coherus BioSciences, Inc. (CHRS) announced that it will release its fourth quarter and full year 2022 financial results on March 6, 2023, after market close. The company will host a conference call and webcast at 5:00 pm ET that same day to discuss the results and provide a business update. Interested parties can access the conference call by pre-registering for dial-in information. A replay of the webcast and press release will be available on Coherus' investor website after the call.
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.
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