Inovio Pharmaceuticals, Inc. announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that data from its completed Phase 1/2 trial of INO-3107 for the treatment of RRP could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial would not be required to support this submission. INOVIO will be required to initiate a confirmatory trial prior to BLA submission for accelerated approval and satisfy all other FDA filing requirements.
Market Closed -
Other stock markets
|
5-day change | 1st Jan Change | ||
10.57 USD | +4.40% | +9.19% | +72.71% |
EPS Revisions
1st Jan change | Capi. | |
---|---|---|
+72.71% | 274M | |
+1.51% | 42.75B | |
+8.57% | 41.34B | |
+49.22% | 41.61B | |
-12.36% | 26.59B | |
+8.92% | 25.49B | |
-25.13% | 18.12B | |
+29.17% | 12.24B | |
-3.12% | 11.76B | |
+6.35% | 11B |
- Stock Market
- Equities
- INO Stock
- News Inovio Pharmaceuticals, Inc.
- Inovio Pharmaceuticals, Inc. Receives FDA Feedback That Data from Completed Phase 1/2 Trial of INO-3107