APLT - Applied Therapeutics: Speedy Regulatory Review Of Govorestat Might Be Possible

2024-02-16 15:25:00 ET

Summary

• Positive 12-month interim results from the phase 3 INSPIRE study using govorestat for the treatment of patients with SORD deficiency achieved.
• Pre-NDA meeting with FDA to be sought out after to see if an NDA submission of govorestat for SORD deficiency could be done with only the positive 12-month interim data.
• 24-month interim results from the phase 3 INSPIRE study, using govorestat for the treatment of patients with SORD deficiency, is the next data readout to be expected.
• The NDA of govorestat for galactosemia has been submitted by the FDA and the EMA has validated the MAA; There is a good chance that Applied Therapeutics could receive regulatory approval for one or both of these territories.

Applied Therapeutics ( APLT ) announced positive 12-month interim results from its phase 3 INSPIRE study using AT-007 for the treatment of patients with Sorbitol dehydrogenase deficiency [SORD deficiency]. The last time I spoke about this biotech, I noted that it had several value generating inflection points using AT-007 for the treatment of patients with rare diseases. I spoke about such possible inflection points in a prior Seeking Alpha article entitled " Applied Therapeutics: Multiple Inflection Points Could Generate Substantial Value ". While the advancement of AT-007 for the treatment of patients with Galactosemia continues to be in the process of possible review/acceptance in both the U.S. and European territories, the data readout of the phase 3 ARISE-HF study using AT-001 for the treatment of patients with diabetic cardiomyopathy [dCM] was not successful ....

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