Coherus Stock Price, News & Analysis

Coherus BioSciences has received FDA approval for YUSIMRY (adalimumab-aqvh), a biosimilar to Humira, indicating its potential for treating several inflammatory diseases, including rheumatoid arthritis and Crohn’s disease. This marks Coherus's second FDA-approved product. YUSIMRY, with proven biosimilarity to Humira, presents a significant commercial opportunity, given Humira's $16 billion U.S. sales in 2020. Coherus plans to launch YUSIMRY post-July 1, 2023, aiming to increase patient access and reduce healthcare costs.

Coherus BioSciences (Nasdaq: CHRS) has appointed Theresa LaVallee, Ph.D., as the new Chief Development Officer, effective immediately. Dr. LaVallee, a seasoned executive with over 25 years in drug discovery and development, will oversee regulatory matters and product development. She aims to enhance the company’s focus on immuno-oncology, particularly with its lead asset, toripalimab, a PD-1 inhibitor. Her extensive background includes roles at the Parker Institute for Cancer Immunotherapy and AstraZeneca, positioning her to significantly contribute to Coherus' growth in immuno-oncology.

Coherus BioSciences (CHRS) announced on December 16, 2021, that it granted stock options for 367,000 shares to new employees, with an exercise price of $17.06. The grants included 200,000 shares for a Chief level executive, 45,000 shares for a Vice President, and 122,000 shares for other non-officer employees. This compensation strategy is part of the 2016 Employment Commencement Incentive Plan, aimed at attracting new talent.

Coherus strives to enhance access to affordable medicines while delivering savings to the healthcare system.

Coherus and Junshi Biosciences announced positive interim results from the Phase 3 study CHOICE-01, showing significant overall survival improvement in advanced non-small cell lung cancer (NSCLC) patients treated with toripalimab plus chemotherapy.

The FDA is being engaged for a potential Biologics License Application (BLA) supplement submission. Toripalimab, already under priority review for other indications, demonstrates robust efficacy across multiple cancer types, positioning both companies for future growth in oncology.

Coherus BioSciences (CHRS) and Junshi Biosciences announced that the FDA has granted Orphan Drug Designation for toripalimab in treating esophageal cancer. This designation supports the development of therapies for rare diseases affecting under 200,000 patients in the U.S. Esophageal cancer claims approximately 15,000 lives annually in the U.S. Coherus plans to file a BLA supplement in 2022 for toripalimab combined with chemotherapy, based on positive results from the JUPITER-06 clinical trial which showed significant improvements in survival for treated patients.

Coherus BioSciences, Inc. (Nasdaq: CHRS) announced the grant of stock options for 177,500 shares to several newly hired employees, effective November 5, 2021. The granted options have an exercise price of $17.81 per share, reflecting the closing trading price on the grant date. A newly hired Vice President received options for 45,000 shares, while 11 non-officer employees received the remaining 132,500 shares. This incentive plan aims to attract new talent to the company.

Coherus BioSciences (CHRS) reported key milestones and financial results for Q3 2021, highlighting significant advances in its product portfolio. Three biologics license applications (BLAs) are under FDA review, including toripalimab for advanced nasopharyngeal carcinoma, with priority review slated for April 2022. Q3 net product revenue fell to $82.5 million from $113.6 million YoY. The company posted a GAAP net loss of $38.5 million. Coherus maintains a strong cash position of $468.7 million and anticipates increased R&D and SG&A expenses, projecting a full-year spending between $370 million to $400 million.

Coherus BioSciences (Nasdaq: CHRS) announced that the Centers for Medicare & Medicaid Services will continue to offer increased Medicare reimbursement through the end of 2022 for select drugs, including its product UDENYCA^® (pegfilgrastim-cbqv). This follows transitional pass-through payment status expiration on March 31, 2022, ensuring reimbursement levels remain unchanged in the 340B outpatient hospital setting. UDENYCA^® is highlighted as the leading pegfilgrastim pre-filled syringe in the U.S., aimed at reducing infection risks in cancer patients receiving myelosuppressive therapy.

The FDA has accepted Coherus BioSciences' Biologics License Application (BLA) for toripalimab, an anti-PD-1 monoclonal antibody, for treating nasopharyngeal carcinoma (NPC). This BLA, which includes toripalimab with chemotherapy and as monotherapy, has been granted Priority Review, with a target action date of April 2022. Coherus aims to establish a new treatment standard for NPC, an aggressive cancer lacking FDA-approved immuno-oncology options. The development is supported by pivotal clinical studies POLARIS-02 and JUPITER-02.