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Risk Factors Update Summary
- We initiated an NDA submission in June 2024 for sebetralstat for on-demand treatment of HAE attacks in adults and adolescents over age 12.
- Disruptions at the FDA or other regulatory authorities due to funding shortages could significantly impact our business operations.
- Under the Tax Cuts and Jobs Act, net operating loss carryforwards generated after 2017 will offset only 80% of taxable income.
- Legislative initiatives to contain healthcare costs may impose additional pricing pressures on sebetralstat and future product candidates.
- Our reliance on third parties for clinical trials may lead to delays or increased costs, adversely affecting our business.
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=1348911&owner=exclude
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