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| Name | Symbol | Market | Type |
|---|---|---|---|
| Roche Holdings Ltd AG (QX) | USOTC:RHHBY | OTCMarkets | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.57 | 1.95% | 29.83 | 29.78 | 29.86 | 30.08 | 29.715 | 30.04 | 4,829,456 | 21:22:28 |
From May 2019 to May 2024
By Colin Kellaher
Roche Holding AG's (ROG.EB) Genentech unit Wednesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to Gazyva for adults with lupus nephritis, a potentially life-threatening inflammation of the kidneys.
Genentech said the designation is based on a phase II study in which Gazyva in combination with standard of care showed enhanced efficacy compared to placebo in achieving complete renal response at one year.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
There are currently no FDA-approved medicines for lupus nephritis, Genentech said.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 18, 2019 06:25 ET (10:25 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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