Biotech pulls plans to file accelerated approval after FDA 'change in direction' — shares plummet
When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were then on a smooth road toward an accelerated approval, with plans to file an NDA in the third quarter of 2021.
Regulators, though, apparently changed their mind.
Applied has decided to hold on submitting an NDA for AT-007 as a treatment for galactosemia, the company disclosed, following discussions with the FDA in which the agency indicated that “clinical outcomes data will likely be required for approval.”
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