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.
On April 27, 2023, Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced that data from four pivotal clinical studies of toripalimab will be presented at the ASCO Annual Meeting from June 2-6, 2023. Key presentations include final overall survival analyses from phase 3 studies for nasopharyngeal carcinoma and non-small cell lung cancer, and interim analyses for resectable stage cancers. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for advanced recurrent nasopharyngeal carcinoma. This demonstrates the potential of toripalimab, an anti-PD-1 monoclonal antibody, in treating multiple cancer types, with ongoing studies covering over 15 indications globally.
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.
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