Travere Therapeutics, Inc. TVTX shares are trading higher Tuesday. The company announced several FDA regulatory updates after the market close on Monday.
The Details:
Travere Therapeutics announced the completion of a successful pre-NDA meeting with the FDA for Filspari. The company said that it will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of Filspari to full approval.
The Company also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS). The company said the FDA communicated that the Phase 3 Duplex study results alone are not sufficient to support an sNDA submission for an FSGS indication for sparsentan.
Following the company's announcements, Citigroup analyst Carly Kenselaar upgraded Travere Therapeutics from Neutral to Buy and raised the price target from $7 to $10.
Also, HC Wainwright analyst Ed Arce reiterated Travere Therapeutics with a Buy and maintained a $18 price target.
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TVTX Price Action: According to Benzinga Pro, Travere Therapeutics shares are up by 25% at $7.89 at the time of publication.
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