Coherus Oncology, Inc. reports commercial-stage oncology developments centered on LOQTORZI® (toripalimab-tpzi), an approved next-generation PD-1 inhibitor for recurrent or metastatic nasopharyngeal carcinoma. Company updates also cover its antibody immunotherapy pipeline, including tagmokitug, an anti-CCR8 cytolytic antibody, and casdozokitug, an IL-27 antagonistic antibody, across solid-tumor programs such as liver, prostate, head and neck, colorectal, gastric and esophageal cancers.
Recurring news includes financial results, LOQTORZI revenue commentary, clinical-development updates, strategic partnerships, investor-conference presentations, public common-stock offerings, debt reduction and other capital-structure actions tied to the company's transition from biosimilars to innovative oncology.
Coherus BioSciences (Nasdaq: CHRS) is set to present findings on toripalimab, an anti-PD-1 antibody, at the ASCO 2021 plenary session on June 6, 2021. The data stems from the pivotal JUPITER-02 Phase 3 clinical trial focused on treating recurrent or metastatic nasopharyngeal carcinoma. This session highlights significant studies, addressing a common cancer with limited treatment options. Additionally, multiple other abstracts related to toripalimab have been accepted for further presentation.
Coherus BioSciences has received significant interim results from the JUPITER-06 clinical trial, indicating that the anti-PD-1 monoclonal antibody toripalimab, when combined with paclitaxel/cisplatin, significantly improves progression-free survival and overall survival for patients with advanced esophageal squamous cell carcinoma (ESCC). This randomized phase 3 trial enrolled 514 patients, and the full data release is anticipated later this year. Coherus is also working on filing several Biologics License Applications for toripalimab.
Coherus BioSciences (Nasdaq: CHRS) has completed a stock sale to Junshi Biosciences, raising $50 million from the sale of 2,491,998 shares priced at $20.06 per share. This transaction follows a collaboration agreement for the development of toripalimab, a PD-1 antibody, in the U.S. and Canada. Coherus paid $150 million upfront for exclusive rights and will also pay royalties and potential milestone payments totaling up to $380 million. The partnership aims to expedite the introduction of toripalimab for treating recurrent nasopharyngeal carcinoma.
Coherus Biosciences (CHRS) and Junshi Biosciences have initiated a rolling submission of the Biologics License Application (BLA) for toripalimab to the FDA for treating recurrent or metastatic nasopharyngeal carcinoma (NPC).
The FDA granted Breakthrough Therapy Designation for toripalimab, indicating a potential significant improvement over existing therapies. Coherus will oversee all commercialization activities in the U.S. and Canada following regulatory clearance. The companies also plan to file additional BLA supplements for various cancers in the next three years.
Coherus BioSciences (Nasdaq: CHRS) announced their participation in two upcoming investor conferences in March 2021. The 41st Annual Cowen Healthcare Conference will take place on March 1 at 4 p.m. ET, followed by the Barclays Global Healthcare Conference on March 9 at 1:15 p.m. ET. Investors can access the audio of these presentations on the Coherus BioSciences website. The company focuses on providing cost-effective medicines to improve patient care and reduce healthcare costs.
Coherus BioSciences reported 2020 product revenues of $476 million, with $110 million in Q4. Strong performance of UDENYCA® helped maintain a 21% market share in the pegfilgrastim category. The company completed a successful BLA acceptance for CHS-1420 and plans to file FYB201's BLA mid-2021. The collaboration with Junshi Biosciences aims to enhance their immuno-oncology portfolio, with the first BLA filing for toripalimab expected in 2021. However, lower UDENYCA® net sales are anticipated in 2021 due to COVID-19 impacts.
Coherus BioSciences (CHRS) will announce its fourth quarter and full year 2020 financial results on February 24, 2021, after market close. The company will host an investor conference call at 4:30 p.m. ET to discuss its financial performance and corporate updates. Interested participants can join via telephone or webcast. Coherus is focused on providing cost-effective medicines to improve patient access and reduce healthcare costs.
Coherus BioSciences (CHRS) announced that the FDA has accepted its Biologics License Application for CHS-1420, a Humira® biosimilar, with a decision expected by December 2021. If approved, CHS-1420 could launch in the U.S. on or after July 1, 2023. The Humira® market is projected to exceed $18 billion in annual sales by then, indicating a significant opportunity for Coherus. The company intends to leverage these revenues to expand its biosimilar and immuno-oncology portfolios.
Coherus BioSciences (CHRS) announced the resignation of CFO Jean-Frédéric Viret, effective March 7, 2021. McDavid Stilwell has been appointed as the new CFO. Viret's contributions were acknowledged by CEO Denny Lanfear, who expressed excitement about Stilwell's extensive experience in finance and corporate strategy. Stilwell aims to help the company achieve its strategic and financial goals, focusing on enhancing patient access to medicines while improving healthcare system savings. Coherus aims to bolster its immuno-oncology pipeline and continue its biosimilar launches through 2023.
Coherus BioSciences has announced a collaboration with Junshi Biosciences to develop and commercialize toripalimab, an anti-PD-1 antibody, in the U.S. and Canada. Coherus will pay $150 million upfront and has options for two other treatment candidates. The FDA granted breakthrough therapy designation for toripalimab, with the first BLA filing expected this year for nasopharyngeal carcinoma. The deal positions Coherus in a growing market projected to exceed $25 billion by 2025, enhancing its pipeline and growth potential.