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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Xeris Biopharma Holdings Inc | NASDAQ:XERS | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 1.89 | 1.90 | 1.92 | 10 | 11:46:20 |
From May 2022 to May 2024
By Chris Wack
Xeris Biopharma Holdings Inc. said Monday that the Food and Drug Administration granted orphan-drug exclusivity for Recorlev to treat adults with Cushing's syndrome, a potentially fatal endocrine disease.
As the first approval of Recorlev for Cushing's syndrome, Xeris is entitled to seven years of exclusivity from its FDA approval date of Dec. 30, 2021.
This regulatory exclusivity is in addition to the patent exclusivity under Xeris' U.S. patents covering Recorlev and its therapeutic use, which extends to at least March 2040.
The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 30, 2023 07:43 ET (12:43 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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