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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.
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Coherus (Nasdaq: CHRS) and Junshi Biosciences have completed the rolling submission of a Biologics License Application (BLA) to the FDA for toripalimab in combination with chemotherapy and as a monotherapy for nasopharyngeal carcinoma (NPC). The FDA granted Breakthrough Therapy Designation for both treatment options, intended to expedite drug development for severe diseases. Toripalimab has shown significant efficacy in clinical studies and received early approval in China. Coherus plans to file additional BLAs for toripalimab over the next three years.
On August 27, 2021, Coherus BioSciences (Nasdaq: CHRS) announced the grant of stock options totaling 278,000 shares to newly hired employees, effective as of August 26, 2021. The options have an exercise price of $15.82 per share, matching the closing price on the grant date. Among the recipients, two Vice Presidents received options for 45,000 shares each, while an additional 188,000 shares were granted to fifteen non-officer employees. This grant is part of the 2016 Employment Commencement Incentive Plan approved by the board to attract new talent.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced positive interim results from the CHOICE-01 Phase 3 trial evaluating toripalimab plus chemotherapy for advanced non-small cell lung cancer (NSCLC). The interim analysis met its primary endpoint, showing a significant improvement in progression-free survival (PFS) of 8.3 months versus 5.6 months with chemotherapy alone (HR=0.58, p=0.0001). Both squamous and non-squamous NSCLC patients benefited, leading to plans for potential regulatory submissions in the US and China.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announced that the FDA granted Breakthrough Therapy Designation for toripalimab combined with chemotherapy for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).
The designation will expedite the review process, providing closer guidance from the FDA. A biologics license application (BLA) for this combination and for toripalimab monotherapy for second/third line NPC is expected this quarter.
The designation is backed by positive results from the JUPITER-02 trial, showing significant progression-free survival improvements.
Coherus BioSciences (CHRS) reported Q2 2021 net product revenue of $88 million from UDENYCA®, with a net loss of $29.9 million. The company is advancing its portfolio, including a BLA for toripalimab expected to be submitted soon, alongside submissions for biosimilars CHS-201 and CHS-1420. R&D expenses surged to $54.8 million due to intensified development efforts. Despite a cash balance of $454.4 million, the company anticipates $370M-$400M in total R&D and SG&A expenses for the full year, reflecting high investment in product development and commercialization.
Coherus BioSciences, Inc. (CHRS) will announce its second quarter 2021 financial results on August 5, 2021, after market close. A conference call will be held at 5 p.m. ET to discuss these results and provide a business update. Interested parties can access the conference via a toll-free number or listen to a webcast. Financial results will also be posted on the Coherus website following the announcement. Coherus aims to enhance access to affordable medicines while delivering cost savings to the healthcare system.
Coherus BioSciences has appointed Dr. Ildiko Csiki as Chair of its Scientific Advisory Board, bringing over 20 years of experience in the field of cancer immunotherapies. Under her leadership, the SAB will collaborate with Coherus to enhance its immuno-oncology portfolio, particularly focusing on toripalimab, a PD-1 blocking antibody in development. This appointment is expected to strengthen Coherus' position as it aims for multiple therapeutic indications and registrations through its commercial biosimilar operations.
Coherus BioSciences announced the grant of stock options to newly hired employees effective July 6, 2021. A total of 221,500 shares were allocated, with a per share exercise price set at $13.63, matching the closing price on the grant date. Notably, a newly appointed Vice President received options for 45,000 shares. This action is part of the Company's 2016 Employment Commencement Incentive Plan, aimed at incentivizing new talent to join the organization.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences will host a virtual investor event on June 7, 2021, at 6 p.m. ET. The event will discuss toripalimab clinical data from the 2021 ASCO Annual Meeting, including results from the JUPITER-02 trial for treating nasopharyngeal carcinoma. Key speakers include experts from Junshi Biosciences and Coherus. Participants can join via phone or webcast. An archived version will be available post-event. For more information, visit the Coherus website.
Coherus BioSciences (CHRS) and Junshi Biosciences announced positive results from the Phase 3 JUPITER-02 study, showing that toripalimab combined with chemotherapy significantly improved progression-free survival (PFS) for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). Median PFS was 11.7 months for the toripalimab group compared to 8.0 months for chemotherapy alone. Additionally, a 40% reduction in risk of death was noted, although overall survival data is not yet mature. The results will be presented at the 2021 ASCO plenary session on June 6, 2021.