Short answer
Xeris Biopharma Holdings, Inc. (XERS) filed an 8-K current report with the SEC on February 27, 2026 reporting Item 7.01 (Regulation FD Disclosure). Patent infringement suit filed under Hatch-Waxman Act against two generic drug companies seeking to market generic RECORLEV (levoketoconazole).
Xeris Biopharma Holdings, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Patent infringement suit filed under Hatch-Waxman Act against two generic drug companies seeking to market generic RECORLEV (levoketoconazole)
- Filing triggers automatic 30-month FDA approval stay for the ANDAs, protecting RECORLEV exclusivity during litigation
- RECORLEV is Xeris's key commercial product (treatment for Cushing's syndrome), making generic defense critical to revenue protection
- Lawsuit filed in U.S. District Court, District of New Jersey: standard venue for Hatch-Waxman patent litigation
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other Xeris Biopharma Holdings, Inc. 8-K filings
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