Coherus BioSciences, Inc. - CHRS STOCK NEWS

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.

Coherus BioSciences, a commercial stage biopharmaceutical company, announced that senior management will present at the Bank of America Health Care Conference on May 12, 2021, at 1:15 p.m. EST. The audio of the presentation will be available on their investors page. Coherus is focused on increasing access to cost-effective medicines that can significantly impact patients’ lives while delivering savings to the health care system. For more details, visit their website.

Coherus BioSciences reported a GAAP net loss of $173 million for Q1 2021, largely due to a $145 million upfront payment to Junshi Biosciences for toripalimab rights. UDENYCA® net sales reached $83 million, maintaining a 20% market share. The company initiated the first BLA submission for toripalimab with positive interim data from pivotal trials. Coherus expects four candidates to gain approval in the U.S. within two years, enhancing revenue potential. The company had $400 million in cash as of March 31, 2021.