Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy
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Intra-Cellular Therapies has submitted a supplemental New Drug Application to the FDA for CAPLYTA, aiming to treat Major Depressive Disorder as an adjunctive therapy.
December 03, 2024 | 12:45 pm
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Intra-Cellular Therapies has submitted a supplemental New Drug Application to the FDA for CAPLYTA, targeting its use as an adjunctive therapy for Major Depressive Disorder. This regulatory step could lead to expanded use and market for CAPLYTA.
The submission of a supplemental New Drug Application to the FDA is a significant regulatory step that could lead to an expanded market for CAPLYTA if approved. This could positively impact ITCI's stock price as it may increase revenue potential.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100