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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Gsk Plc | LSE:GSK | London | Ordinary Share | GB00BN7SWP63 | ORD 31 1/4P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -24.50 | -1.35% | 1,788.00 | 1,787.50 | 1,788.00 | 1,802.00 | 1,785.00 | 1,792.50 | 733,116 | 12:27:22 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 30.33B | 4.93B | 1.1970 | 14.97 | 73.78B |
From May 2022 to May 2024
By Anthony O. Goriainoff
GSK PLC said Wednesday that momelotinib's new drug application, or NDA, has been accepted by the U.S. Food and Drug Administration for the treatment of myelofibrosis.
The U.K. pharmaceutical company said the FDA assigned a Prescription Drug User Fee Act, or PDUFA, action date of June 16, 2023.
The PDUFA refers to the date by which the agency's review process must be completed.
The FTSE 100-listed company said the NDA is based on results from key Phase 3 trials which met all primary and key secondary endpoints, and added that momelotinib wasn't currently approved in any market.
Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 17, 2022 02:31 ET (06:31 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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