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Travere Therapeutics Chief Legal Officer Sells $300k Travere Therapeutics CLO sold $300,000 of TVTX stock on Apr 2, 2026 (Investing.com); obtain the Form 4 and review for 10b5-1 status and concurrent insider activity.

Travere Therapeutics Chief Legal Officer Sells $300k: Travere Therapeutics CLO sold $300,000 of TVTX stock on Apr 2, 2026 (Investing.com); obtain the Form 4 and review for 10b5-1 status and concurrent insider… 👈 Read full analysis #TravereTherapeutics #TVTX #InsiderTrading #StockMarket #Investing

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Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS Travere Therapeutics (Nasdaq: TVTX) said the FDA extended review of its supplemental NDA for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS), setting a new PDUFA target action date of April 13, 2026.The FDA deemed Travere's recent responses to requests for further characterization of clinical benefit a Major Amendment, which triggered the extension. No additional safety or manufacturing information was requested. Travere says commercial launch preparations continue in parallel. FILSPARI is already approved by the FDA and EMA for slowing kidney function decline in adults with IgA nephropathy.

#TVTX Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS

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PRISM Morning Movers
Premarket Gainers:
AlphaTON Capital ( #ATON) up 141%
Ambitions Enterprise Management Co. ( #AHMA) up 138%
Decoy Therapeutics ( #DCOY) up 90%
Beyond Air, Inc. ( #XAIR) up 46%

Premarket Decliners:
Signing Day Sports ( #SGN) down -33%
Travere Therapeutics ( #TVTX) down -31%

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Travere Therapeutics Provides Corporate Update and 2026 Outlook Travere Therapeutics, Inc. today announced that, based on preliminary and unaudited financial data, the Company expects total U.S. net product sales for the fourth quarter of 2025 to be approximately $127 million. For the fiscal year 2025, the Company expects total U.S. net product sales to be approximately $410 million. 908 new patient start forms were...

#TVTX Travere Therapeutics Provides Corporate Update and 2026 Outlook

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Breaking News: ( NASDAQ: #TVTX ) Why Travere Therapeutics Stock Popped by Nearly 14% on Wednesday

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Travere Therapeutics Announces Late-Breaking Data from Phase 3 DUPLEX Study of FILSPARI in FSGS Presented at the American Society of Nephrology (ASN) Kidney Week 2025 Travere Therapeutics (Nasdaq: TVTX) presented late-breaking Phase 3 DUPLEX data at ASN Kidney Week 2025 (Nov 6-9). The analyses show FILSPARI (sparsentan) patients were more likely to reach urine protein-to-creatinine ratio (UPCR) below 0.7 g/g versus maximum labeled dose irbesartan (37.5% vs 21.4%, RR 1.8).At week 108, rates were 19% vs 11.2% (RR 1.7). DUPLEX-aligned RaDaR modeling linked achieving UPCR24% lower 5-year kidney-failure risk (HR 0.76).

#TVTX Travere Therapeutics Announces Late-Breaking Data from Phase 3 DUPLEX Study of FILSPARI in FSGS Presented at the American Society of Nephrology (ASN) Kidney Week 2025

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Travere Therapeutics Reports Third Quarter 2025 Financial Results Travere Therapeutics (NASDAQ: TVTX) reported 3Q 2025 total revenue of $164.9 million, which included a $40.0 million market access milestone and license revenue. The company reported a $25.7 million net income for 3Q 2025 (or $0.29 per basic share) versus a net loss in the year-ago quarter and held $254.5 million in cash, cash equivalents and marketable securities as of Sept 30, 2025. FILSPARI commercial momentum continued: the release cites 155% year-over-year U.S. growth and program updates ahead of a PDUFA target action date of Jan 13, 2026 for FSGS. The company also repaid roughly $68.9 million of 2025 convertible notes and reported progress on pegtibatinase development and global partnerships.

#TVTX Travere Therapeutics Reports Third Quarter 2025 Financial Results

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Breaking News: ( NASDAQ: #TVTX ) CSL Vifor and Travere Therapeutics Recognize Updated KDIGO Clinical Practice Guidelines for IgA Nephropathy

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Breaking News: ( NASDAQ: #TVTX ) Travere Therapeutics Inc. (NASDAQ: TVTX) Making Surprising Moves in Wednesday Session

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NEWS: ( NASDAQ: #TVTX ) Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI (sparsentan) in FSGS

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Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI® (sparsentan) in FSGS Travere Therapeutics (Nasdaq: TVTX) announced that the FDA will no longer require an advisory committee meeting for the supplemental New Drug Application (sNDA) of FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The PDUFA target action date remains January 13, 2026.The sNDA is supported by the Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated FILSPARI's superior efficacy in reducing proteinuria compared to irbesartan. Notably, patients achieving proteinuria remission showed a 67% to 77% lower risk of kidney failure. If approved, FILSPARI would become the first medication specifically indicated for FSGS treatment.

#TVTX Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI® (sparsentan) in FSGS

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53.5% Toxic Metabolite Reduction: Travere's Breakthrough HCU Drug Shows Promise in Year-Long Study Pegtibatinase maintained 53.5% homocysteine and 67.1% methionine reductions over 50 weeks in classical HCU patients. Phase 3 HARMONY study enrollment to restart in 2026.

#TVTX Travere Therapeutics Presents Abstracts at the 15th International Congress of Inborn Errors of Metabolism

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Major Update: FDA Reduces FILSPARI Monitoring from Monthly to Quarterly for IgA Nephropathy Patients FDA simplifies FILSPARI liver monitoring to quarterly checks and removes embryo-fetal toxicity monitoring requirements. Drug under review for FSGS indication with PDUFA date of Jan 2026.

#TVTX Travere Therapeutics Announces U.S. FDA Approves REMS Modification for FILSPARI® (sparsentan) in IgA Nephropathy

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Travere Earnings Reveal Blockbuster Growth: FILSPARI Sales Soar 165% as FDA Decision Looms for FSGS Treatment Strong Q2 performance drives Travere's growth with FILSPARI sales reaching $71.9M. See full financial results and pipeline updates for FSGS approval timeline.

#TVTX Travere Therapeutics Reports Second Quarter 2025 Financial Results

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Pomerantz Law Firm Launches Investigation into Travere Therapeutics for Potential Securities Fraud Pomerantz Law Firm is investigating claims against Travere Therapeutics over potential securities fraud. Investors may join a class action.

Pomerantz Law Firm Launches Investigation into Travere Therapeutics for Potential Securities Fraud #United_States #New_York #Pomerantz_Law_Firm #Travere_Therapeutics #TVTX

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Pomerantz Law Firm Launches Investigation for Travere Therapeutics Investors Following Stock Drop Pomerantz Law Firm is investigating potential securities fraud claims against Travere Therapeutics, Inc. after a significant stock decline.

Pomerantz Law Firm Launches Investigation for Travere Therapeutics Investors Following Stock Drop #United_States #New_York #Pomerantz_Law_Firm #Travere_Therapeutics #TVTX

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England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy CSL Vifor announced that FILSPARI® (sparsentan) has received recommendation from England's National Institute for Health and Care Excellence (NICE) for treating IgA nephropathy. The treatment is approved for adults with urine protein excretion ≥1.0 g/day or urine protein-to-creatinine ratio ≥0.75 g/g. This marks the first non-immunosuppressive dual-action therapy recommended for this condition, which affects over 22,000 adults in England. The recommendation follows MHRA authorization in April 2025, with commercial availability expected from July 2025. IgA nephropathy, the most common primary glomerular disease worldwide, leads to kidney failure in 30-40% of patients within 10 years of diagnosis if not properly controlled. The NICE decision requires NHS England to fund the treatment within 90 days of final publication, expected on June 27, 2025.

#CSLLY #TVTX England's NICE recommends FILSPARI® (sparsentan) as a treatment option for IgA nephropathy

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Breakthrough: FDA to Review First-Ever Treatment for Rare Kidney Disease FSGS - Decision Expected January 2026 FDA sets January 2026 decision date for potential first-ever FSGS treatment. Phase 3 data shows superior kidney function protection. See complete trial results.

#TVTX Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS

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CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy GALLEN, Switzerland and SAN DIEGO, April 29, 2025/ PRNewswire/-- CSL Vifor and Travere Therapeutics, Inc., are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval into a standard marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein...

#CSLLY #TVTX CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy

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Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking priority review for FILSPARI® (sparsentan) to treat focal segmental glomerulosclerosis (FSGS). The submission is backed by Phase 3 DUPLEX and Phase 2 DUET studies, which demonstrated FILSPARI's superior efficacy in reducing proteinuria compared to irbesartan in both adults and children.FILSPARI, a non-immunosuppressive oral medication targeting podocyte injury, could become the first FDA-approved treatment for FSGS, a rare kidney condition and leading cause of kidney failure. The drug is currently approved for IgA nephropathy to slow kidney function decline.The FDA has 60 days to accept the application for review, with a decision expected in Q2 2025. Additionally, the FDA has deemed REMS monitoring for embryo-fetal toxicity no longer necessary, and the company plans to submit an amendment to modify liver monitoring requirements, with a PDUFA target date of August 28, 2025.

#TVTX Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS

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Travere Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results Travere Therapeutics (NASDAQ: TVTX) reported strong financial results for Q4 and full year 2024. Net product sales reached $73.5 million in Q4 2024 (up from $39.9 million in Q4 2023) and $226.7 million for full year 2024 (up from $127.5 million in 2023). FILSPARI sales contributed $49.6 million in Q4 and $132.2 million for the full year.The company plans to submit an sNDA around the end of Q1 2025 seeking traditional approval of FILSPARI for FSGS. The FDA granted full approval to FILSPARI in September 2024 for slowing kidney function decline in adults with primary IgAN. The company received 693 new patient start forms in Q4 2024.As of December 31, 2024, Travere had cash, cash equivalents, and marketable securities of $370.7 million, including $134.7 million from a November 2024 common stock offering.

#TVTX Travere Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results

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Breaking News: ( NASDAQ: #TVTX ) Travere Therapeutics to Submit sNDA for FILSPARI (sparsentan) in FSGS

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Travere's FILSPARI Eyes Breakthrough: First-Ever Treatment for 40,000 FSGS Patients Travere advances FILSPARI towards potential first-ever FSGS treatment following FDA meeting. Phase 3 data shows promising results for rare kidney disorder.

#TVTX Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS

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