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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 (Nasdaq: CHRS) and Shanghai Junshi Biosciences announced that the FDA has granted Orphan Drug Designation for toripalimab, a PD-1 inhibitor, for small cell lung cancer (SCLC). This designation, meant for rare diseases, aims to boost the drug's development and commercialization. SCLC has a poor prognosis, with a five-year survival rate of around 20%. The ongoing JUPITER-08 Phase 3 trial is assessing toripalimab combined with chemotherapy as a first-line treatment for extensive stage SCLC. Topline data is expected later this year.
Coherus (CHRS) and Junshi Biosciences announced significant results from the JUPITER-02 study, a Phase 3 trial assessing toripalimab with chemotherapy for advanced nasopharyngeal carcinoma (NPC).
The trial revealed a median progression-free survival (PFS) of 21.4 months for the toripalimab group versus 8.2 months for placebo, showing a strong statistical significance. Interim overall survival (OS) data indicates a 41% reduced risk of death.
The FDA has granted breakthrough therapy designation for toripalimab, with a biologics license application currently under priority review.
Coherus BioSciences (NASDAQ: CHRS) announced on April 5, 2022, that it granted stock options for 461,000 shares to newly hired employees as of March 31, 2022. These options have an exercise price of $12.91, aligned with the closing price on the grant date. A Chief level executive received options for 200,000 shares and 50,000 restricted stock units, while 18 non-officer employees were awarded options for a total of 261,000 shares. This move aims to attract new talent under the 2016 Employment Commencement Incentive Plan approved by the Company’s board.
Coherus BioSciences, Inc. (CHRS) is positioning itself for long-term growth by targeting $1.2 billion in annual net sales by 2026. The company is advancing its immuno-oncology pipeline, focusing on its PD-1 inhibitor, toripalimab, which is under FDA review for nasopharyngeal carcinoma. Upcoming product launches include CIMERLI, a Lucentis biosimilar, and YUSIMRY, a Humira biosimilar. Coherus plans to leverage existing commercial infrastructure for these launches, aiming for significant shareholder value creation.
Coherus BioSciences (Nasdaq: CHRS) announced an Analyst Day set for March 29, 2022, at 9:30 a.m. ET in New York City. The event will focus on prospective product launches over the next 15 months, along with updates on the company’s entry into immuno-oncology with PD-1 inhibitor toripalimab and combination therapies. The FDA is reviewing toripalimab for nasopharyngeal carcinoma, with a decision expected by April 30, 2022. Additionally, Coherus plans to launch its Humira biosimilar in 2023 and is pursuing various biosimilars in development.
Coherus BioSciences has appointed Dr. Rosh Dias as Chief Medical Officer, enhancing its leadership at a critical time for upcoming product launches. Dr. Dias, with over 20 years in the biotech sector, has experience in oncology and immuno-oncology. Coherus is preparing to launch several products, including toripalimab, currently under FDA review with a target action date of April 30, 2022. The company intends to utilize cash generated from its existing biosimilars to fund its immuno-oncology initiatives, positioning itself as a leader in innovative therapies for cancer treatment.
Junshi Biosciences and Coherus BioSciences announced positive results from the pivotal CHOICE-01 Phase 3 clinical trial of toripalimab plus chemotherapy for advanced non-small cell lung cancer (NSCLC) patients without EGFR/ALK mutations. The trial met its primary endpoint of progression-free survival (PFS) and a secondary endpoint of overall survival (OS), showing a median PFS of 8.4 months versus 5.6 months with chemotherapy alone (HR=0.49). The study revealed a manageable safety profile and the potential for future trials based on biomarker data. The FDA has granted priority review for toripalimab.
Coherus BioSciences (Nasdaq: CHRS) announced its participation in two key investor conferences in March 2022. The 42nd Annual Cowen Health Care Conference will take place on March 9 at 10:30 a.m. ET, followed by the Barclays Global Healthcare Conference on March 15 at 2:35 p.m. ET. Audio webcasts of both presentations will be available on the investors' section of Coherus' website and will remain archived for 30 days. Investors are encouraged to access the site beforehand for a timely connection.
Coherus BioSciences (CHRS) and Junshi Biosciences announced the publication of results from the JUPITER-06 trial demonstrating that toripalimab combined with chemotherapy significantly improves progression-free survival (PFS) and overall survival (OS) in patients with advanced esophageal squamous cell carcinoma (ESCC). The trial, which involved 514 treatment-naïve patients, showed median OS at 17 months (toripalimab) versus 11 months (placebo), with a hazard ratio of 0.58. Notably, benefits were observed across all PD-L1 expression subgroups, including those with low expression.
Coherus BioSciences (NASDAQ: CHRS) reported Q4 and FY 2021 results, highlighting a net revenue of $73 million in Q4 and $327 million for the year, reflecting declines attributed to increased competition and COVID-19 impacts. The FDA approved YUSIMRY, with a projected launch in 2023, and toripalimab's BLA received priority review for nasopharyngeal carcinoma. The company aims for further diversification with the anticipated launch of CIMERLI. Financial guidance for 2022 estimates combined R&D and SG&A expenses between $415 million and $450 million, coupled with significant projected losses.
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