Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) is one of the most promising stocks according to Wall Street analysts. On June 24, ...

Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25 If approved, FILSPARI could be the first and only approved medicine ...

Syndax now has two approved therapies, but the share price remains under pressure despite these milestones. See why SNDX ...

sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare ...

The ongoing regulatory approval process carries inherent risks, including the possibility that the FDA may not accept the sNDA for review or grant approval within the anticipated timeline.

Junshi Biosciences Announces the sNDA Approval of Toripalimab for the 1st-line Treatment of Melanoma Provided by GlobeNewswire Apr 25, 2025, 11:43:50 AM ...

Key Highlights: FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information. New IV NAC dosing regimen is both safe and effective.

If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics ...

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...

There is no guarantee that the FDA will accept the sNDA for filing, grant priority review of the sNDA or grant approval of FILSPARI for FSGS on the anticipated timeline, or at all.