Core Insights - Travere Therapeutics has completed a Type C meeting with the FDA and plans to submit a supplemental New Drug Application (sNDA) for FILSPARI, targeting focal segmental glomerulosclerosis (FSGS) [1][2] - If approved, FILSPARI could be the first and only approved treatment for FSGS, a rare kidney disorder affecting over 40,000 patients in the U.S. [2][5] - The sNDA submission will rely on data from the Phase 3 DUPLEX and Phase 2 DUET studies, which have shown promising results in reducing proteinuria [1][6][7] Company Updates - The sNDA submission is expected around the end of the first quarter of 2025 [1] - The CEO of Travere Therapeutics expressed optimism about the sNDA submission and highlighted the urgent need for treatment options for FSGS [2] - A conference call and webcast will be held to discuss these updates, scheduled for February 11, 2025, at 8:30 a.m. ET [3][4] Study Insights - The Phase 3 DUPLEX study is noted as the largest interventional study in FSGS, achieving significant results in reducing proteinuria [6][7] - The Phase 2 DUET study demonstrated a greater than two-fold reduction in proteinuria compared to irbesartan, indicating the efficacy of FILSPARI [7] - Both studies support the importance of proteinuria reduction as a key endpoint in FSGS treatment, aligning with findings from the PARASOL workgroup [2][8] Disease Context - FSGS is characterized by progressive kidney scarring and is a leading cause of kidney failure, with no currently approved pharmacologic treatments [5] - The disorder affects both adults and children, highlighting the need for effective therapies [5]

EXHIBIT 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Provides Corporate Update and 2025 Outlook Received 693 new patient start forms for FILSPARI (sparsentan) in the fourth quarter of 2024; approximately $50 million in preliminary net product sales of FILSPARI for the fourth quarter ® sNDA requesting modification of liver monitoring for FILSPARI in IgAN accepted for review by FDA; PDUFA target action date of August 28, 2025 Company ...

Received 693 new patient start forms for FILSPARI® (sparsentan) in the fourth quarter of 2024; approximately $50 million in preliminary net product sales of FILSPARI for the fourth quarter sNDA requesting modification of liver monitoring for FILSPARI in IgAN accepted for review by FDA; PDUFA target action date of August 28, 2025 Company remains on track to provide regulatory update on sparsentan in FSGS by its fourth quarter 2024 earnings call SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutic ...

Core Viewpoint - Travere Therapeutics (TVTX) shows potential for significant upside, with a mean price target of $27.20 indicating a 42.6% increase from the current price of $19.08 [1] Price Target Analysis - The mean estimate consists of 15 short-term price targets with a standard deviation of $8.33, indicating variability among analysts [2] - The lowest estimate is $18, suggesting a 5.7% decline, while the highest estimate predicts a 120.1% increase to $42 [2] - A low standard deviation indicates strong agreement among analysts regarding price movement direction [7] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about TVTX's earnings prospects, with a positive trend in earnings estimate revisions [9] - The Zacks Consensus Estimate for the current year has risen by 0.9% over the past month, with no negative revisions [10] - TVTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11] Caution on Price Targets - Solely relying on price targets for investment decisions may not be wise, as they can mislead investors [3][5][8] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6]

Core Viewpoint - Travere Therapeutics, Inc. will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 8:15 a.m. PT, highlighting its commitment to addressing rare diseases [1] Group 1: Company Overview - Travere Therapeutics is a biopharmaceutical company focused on developing therapies for patients with rare diseases, emphasizing the urgent need for treatment options [2] - The company collaborates with the rare disease community to identify, develop, and deliver life-changing therapies, aiming to provide hope for patients and their families [2] Group 2: Event Details - Eric Dube, Ph.D., the president and CEO of Travere Therapeutics, will be the presenter at the upcoming healthcare conference [1] - A live webcast of the presentation will be available on the company's investor page, with a replay accessible for up to 30 days post-event [1]

Group 1 - Travere Therapeutics received full approval for its sparsentan 200/400 mg tablets, branded as Filspari, for the treatment of IgA nephropathy (IgAN) [1] - IgAN is a chronic kidney disease caused by the immune system producing abnormal antibodies [1] Group 2 - The article does not provide additional relevant content for further summarization.

Dublin, Dec. 18, 2024 (GLOBE NEWSWIRE) -- The "Homocystinuria - Pipeline Insight, 2024" drug pipelines has been added to ResearchAndMarkets.com's offering.This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Homocystinuria pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactiv ...

SAN DIEGO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the pricing of an underwritten public offering of 7,812,500 shares of its common stock at a price to the public of $16.00 per share. All of the shares are being sold by Travere. The gross proceeds from the offering are expected to be $125.0 million, before deducting the underwriting discounts and commissions and offering expenses. The offering is expected to close on November 12, 2024, subject to customary ...

Financial Data and Key Metrics Changes - Net product sales for Q3 2024 reached $61 million, an increase of approximately 80% compared to $33.9 million in Q3 2023, driven by strong performance in the U.S. launch of FILSPARI for IgA nephropathy [60] - Total revenue for Q3 2024 was $62.9 million, up from $37.1 million in the same period last year [61] - Net loss for Q3 2024 was $54.8 million or $0.70 per share, compared to a net income of $150.7 million or $1.97 per share in Q3 2023 [65] Business Line Data and Key Metrics Changes - FILSPARI's net sales grew by more than 30% quarter-over-quarter, with over 500 new patient start forms added during Q3 2024 [8][49] - The company continues to outperform previous rare nephrology launches on all core metrics and is on track to exceed benchmarks for net revenue in the first full year of launch [50] Market Data and Key Metrics Changes - FILSPARI has launched in two key European markets, Germany and Austria, and received temporary marketing approval in Switzerland [16] - The recent draft KDIGO guidelines are expected to drive nephrologists to treat patients more aggressively, which could further enhance FILSPARI's market penetration [55] Company Strategy and Development Direction - The company aims for FILSPARI to become foundational care in IgA nephropathy, leveraging full approval and updated guidelines to educate the nephrology community [9][51] - There is a focus on expanding access to FILSPARI outside the U.S. and preparing for potential sNDA submissions for FSGS indications [15][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for FILSPARI, particularly following full approval and the positive reception of new clinical data [48][59] - The company anticipates a decline in cash used over time, supported by increasing FILSPARI sales and expected milestone payments from partners [66] Other Important Information - The company has submitted an sNDA to modify liver monitoring frequency in the REMS, which, if approved, would improve patient access while maintaining safety [11][29] - The PARASOL initiative has provided new hope for the FSGS community, with potential regulatory pathways being discussed with the FDA [41][42] Q&A Session Summary Question: Insights on PSF metrics and trends in Q4 - Management noted that the minor dip in metrics was attributed to seasonal factors and training, but they are encouraged by the strong growth trajectory post-approval [71][72] Question: Focus of discussions with the FDA regarding PARASOL recommendations - Management indicated that while proteinuria can be a validated surrogate for approval, the totality of data will be important in discussions with the FDA [74][76] Question: Additional data on liver monitoring for the submission - The submission includes data from ongoing clinical trials and commercial experience, showing consistent low levels of LFT elevation [79][80] Question: Expectations for the Type C meeting with the FDA - The company plans to propose specific proteinuria thresholds and discuss the overall data package with the FDA [81][83] Question: Inclusion of open-label extension data in the FDA submission - Management confirmed that data from open-label extensions will be included in the submission to the FDA [85] Question: Efforts to help patients get diagnosed and treated earlier - The company is actively educating payers and physicians about the urgency of treating patients earlier based on new guidelines [88] Question: Broader opportunity for FILSPARI in FSGS - Management expressed excitement about the potential market for FILSPARI in FSGS, noting the high unmet need and established prescriber relationships [92][94] Question: Potential updates to FSGS treatment guidelines - Management anticipates that if full approval for Sparsentan is achieved, it could prompt updates to treatment guidelines [96] Question: Compliance metrics for FILSPARI and expected changes with reduced monitoring - High compliance and persistency rates for FILSPARI were reported, with expectations that reduced monitoring frequency will maintain patient engagement [98][100] Question: Payer willingness to reimburse for patients starting below 1 gram of proteinuria - Management noted positive progress with payers recognizing the progressive nature of IgA nephropathy and updating authorization criteria accordingly [102][104] Question: Current expectations for LOE in IgAN - The company expects LOE for Sparsentan to extend into 2033, with additional orphan drug exclusivity extending to September 2031 [106]

or UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________ FORM 10-Q _________________________________ ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-36257 TRAVERE THERAPEUTICS, INC. (Exact na ...