Coherus BioSciences, Inc. - CHRS STOCK NEWS

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.

Coherus BioSciences (Nasdaq: CHRS) will announce its third-quarter 2021 financial results after the market closes on November 8, 2021. A conference call and webcast will follow at 5 p.m. ET, where management will discuss the results and provide a business update. Investors can access the financial results via the company's website after the announcement. Additionally, the conference call can be joined through specified dial-in numbers and a conference ID. Coherus aims to enhance access to cost-effective medicines for impactful patient care.

Coherus BioSciences (Nasdaq: CHRS) announced the unexpected passing of board member Alan C. Mendelson, who had been a director since January 2021. Mendelson was a prominent figure in the biotech industry, previously serving as external legal counsel since the company’s inception in 2010. CEO Denny Lanfear praised Mendelson's immense contributions to the company and the industry. Mendelson's extensive legal career included significant roles at Latham & Watkins LLP and Cooley LLP, advising multiple biotech firms. His loss is felt deeply across various sectors.

Coherus BioSciences (CHRS) announced positive results from a clinical trial evaluating its proposed UDENYCA® On-Body Injector (OBI). The trial demonstrated pharmacokinetic and pharmacodynamic bioequivalence with the current UDENYCA® pre-filled syringe. Enrolled were 189 subjects, and the study met all primary endpoints with no new safety concerns. Coherus plans to seek FDA marketing authorization in 2022 and expects a commercial launch shortly after approval, positioning itself to compete with Neulasta® Onpro®, which holds over 50% market share in pegfilgrastim delivery.

Coherus BioSciences announced positive results from the pivotal COLUMBUS-AMD trial, comparing the efficacy and safety of CHS-201 against Lucentis® in treating wet age-related macular degeneration. Results showed equivalent clinical efficacy and safety between both treatments in a cohort of 477 patients. If approved, CHS-201 could be marketed in the U.S. in late 2022, following the acceptance of its biologics license application by the FDA. The trial's primary endpoint was met, demonstrating significant visual acuity improvement for both treatments.