Risk Factors Update Summary
- Recent U.S. Supreme Court decision may impact claim scope of biological therapeutic products, including certain candidates.
- Terminated enrollment in clinical studies involving davoceticept, focusing on advancing povetacicept and acazicolcept.
- Positive data from RUBY-3 trial may lead to advancing povetacicept into a pivotal study in IgAN.
- Voluntarily terminated enrollment in the Phase 2 study of acazicolcept in SLE, the Synergy study.
- Changes in orphan designation and exclusivity frameworks in the U.S. and EU may affect future designations.
- Increased spending on research and development, exceeding expectations, with ongoing significant investment.
- Elimination of statutory cap on Medicaid Drug Rebate Program rebates may impact financial obligations.
- Potential challenges to FDA authority due to Chevron doctrine reversal may lead to delays in marketing applications.
- Uncertainty regarding new models for drug cost reduction and care quality evaluation may impact future health reform measures.
- Various states enacting privacy legislation may increase compliance costs and potential liability for 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=1626199&owner=exclude
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