Applied Therapeutics, Inc. announced successful completion of a recent pre-New Drug Application (?NDA?) meeting with the Food and Drug Administration (FDA) regarding its govorestat (AT-007) Galactosemia program. Based on discussions with the FDA, the Company believes they are aligned with the FDA and plans to submit an NDA for govorestat (AT-007) for the treatment of Galactosemia in the fourth quarter of this year.
Real-time Estimate
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5-day change | 1st Jan Change | ||
5.24 USD | +2.54% | +19.39% | +52.54% |
09/05 | Applied Therapeutics, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2024 | CI |
09/05 | Earnings Flash (APLT) APPLIED THERAPEUTICS Posts Q1 Revenue $190,000 | MT |
EPS Revisions
1st Jan change | Capi. | |
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+52.54% | 584M | |
+18.77% | 125B | |
+14.05% | 108B | |
-7.16% | 23.64B | |
+1.83% | 22.39B | |
-11.72% | 17.78B | |
-41.74% | 16.43B | |
-13.47% | 16.34B | |
+2.23% | 13.56B | |
+27.13% | 11.59B |
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- Applied Therapeutics, Inc. Announces Successful Pre-Nda Meeting with the Fda and Confirms Plans to Submit Nda for Govorestat (At-007) for Treatment of Classic Galactosemia to Fda in Fourth Quarter 2023