Risk Factors Update Summary
- FDA issued a complete response letter for the cosibelimab BLA on December 15, 2023, with a resubmission planned for marketing approval by January 3, 2024.
- The confirmed objective response rate for cosibelimab in metastatic CSCC increased from 47.4% to 50.0%.
- The Company and TGTX mutually terminated collaborations, reverting full rights back to the Company.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1651407&owner=exclude
This content requires a 'Free' membership to view. Please create one here.
This content requires a 'Free' membership to view. Please create one here.