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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ambrx Biopharma Inc | NASDAQ:AMAM | 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% | 28.00 | 27.92 | 25.00 | 0 | 01:00:00 |
By Chris Wack
Ambrx Biopharma said Wednesday that the U.S. Food and Drug Administration has granted Fast Track designation to its proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517.
The company's ARX517 is intended for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.
Fast Track designation is a process designed to help the development and expedite the review of drugs which may demonstrate substantial improvement over available therapy for serious conditions with unmet medical need.
Ambrx said ARX517 is currently being studied in a Phase 1/2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with mCRPC whose tumors have progressed on at least two prior FDA approved treatments for prostate cancer.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 19, 2023 09:34 ET (13:34 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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