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FDA imposes clinical hold on REGENXBIO gene therapies after tumor case
The FDA has imposed a clinical hold on REGENXBIO’s development programs RGX-111 and RGX-121 after an intraventricular CNS tumor was discovered in a five-year study participant four years after receiving RGX-111. Initial genetic analyses showed an AAV integration event and overexpression of the proto-oncogene PLAG1, but a causal link to the therapy has not yet been confirmed. The affected participant is asymptomatic and, according to the treating physician, is showing positive developmental progress; no tumors have been reported in other participants so far. REGENXBIO is awaiting the full FDA letter; the stock had fallen earlier, but analysts remain largely positive. » More on de.investing.com
Financials
| (EUR) | 2024 | |
|---|---|---|
| Revenue | 119.09K | 72.83% |
| Gross profit | -445.45K | 1.47% |
| Net profit | -3.42M | 21.36% |
| EBITDA | -1.32M | 52.83% |
Fundamentals
| Metric | Value |
|---|---|
Market capitalization | €34.09K |
Number of shares | 395.98M |
52-week high/low | €0.86 - €0.0000861 |
| Dividends | No |
Beta | 0.17 |
P/E ratio | -0.01 |
PEG ratio | 0.00 |
P/B ratio | 0.01 |
P/S ratio | 0.31 |
Company profile
| Name | Regenx Tech Aktie |
| CEO | Donald Edward Weatherbee |
| Employees | 4 |
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