Travere Therapeutics (TVTX) shares rallied 5.9% in the last trading session to close at $14.27. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 55.3% gain over the past four weeks.The company markets Filspari (sparsentan), an oral non-immunosuppressive drug approved for treating IgA nephropathy (IgAN), a rare kidney disease. Filspari has seen strong market demand, generating $47 million in sales in the first ...

Travere Therapeutics (TVTX) announced that the FDA granted full approval to its oral non-immunosuppressive drug Filspari (sparsentan) in IgA nephropathy (IgAN) indication, a rare progressive kidney disease.Following this decision, Filspari is approved for slowing kidney function decline in adults with primary IgAN who are at risk of disease progression. The FDA’s decision also makes Filspari the only non-immunosuppressive medication in the IgAN space.Filspari was initially granted accelerated approval in Fe ...

FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation compared to the active comparator irbesartan in the only Phase 3 head-to-head trial conducted in IgAN As an o ...

Chris Ryan/OJO Images via Getty ImagesInvestment Overview - Background To Upcoming PDUFA - Failed Confirmatory Study Hammers Share Price The last time I covered Travere Therapeutics (NASDAQ:TVTX) it was September 22, 2023, and the San Diego-based biotech's stock price was in free-fall. Earlier that day, the company shared data from a Phase 3 clinical study of its lead asset Filspari (sparsentan), showing that the drug had failed to meet a key primary endpoint, unable to demonstrate a statistically signi ...

SAN DIEGO, Aug. 22, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present two posters in classical homocystinuria (HCU) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) annual symposium in Porto, Portugal, September 3-6, 2024. At SSIEM, the Company will present the trial designs of the pivotal Phase 3 HARMONY Study and ENSEMBLE long-term extension study of pegtibatinase, a novel investigational enzyme replacement therapy for the ...

SAN DIEGO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that company management will present in the following upcoming investor conferences in August: 2024 Wedbush PacGrow Healthcare ConferenceTuesday, August 13, 2024, at 2:30 p.m. ET Canaccord Genuity 44th Annual Growth ConferenceWednesday, August 14, 2024, at 12:30 p.m. ET A live webcast of the Canaccord Genuity 44th Annual Growth Conference presentation will be accessible on the Investor page of Travere’s w ...

SAN DIEGO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ:TVTX) today announced that company management will present in the following upcoming investor conferences in August: 2024 Wedbush PacGrow Healthcare ConferenceTuesday, August 13, 2024, at 2:30 p.m. ET Canaccord Genuity 44th Annual Growth ConferenceWednesday, August 14, 2024, at 12:30 p.m. ET A live webcast of the Canaccord Genuity 44th Annual Growth Conference presentation will be accessible on the Investor page of Travere's we ...

财务数据和关键指标变化 - 第二季度净产品销售额增长77%,达到5220万美元 [36] - 第二季度总收入增长68%,达到5410万美元 [36] - 研发费用同比下降18%,达5060万美元 [37] - 销售及管理费用同比下降2%,达4830万美元 [38] - 第二季度净亏损收窄,达5010万美元 [40] - 截至6月30日,公司现金及等价物为3.254亿美元 [41] 各条业务线数据和关键指标变化 - FILSPARI在第二季度新增521个患者启动表单,连续6个季度实现季度环比增长 [26][27] - 截至第二季度末,约2400名肾脏专科医生获得REMS认证,超过最近罕见肾脏疾病的基准 [28] - FILSPARI获得96%的美国人群的报销通道,获批率也很高 [30] - FILSPARI第二季度净销售额达2710万美元,较第一季度增长37% [31] 各个市场数据和关键指标变化 - 欧洲合作伙伴CSL Vifor即将在欧洲推出FILSPARI [13] - 日本合作伙伴Renalys已在日本启动FILSPARI的关键性临床试验,预计2025年下半年完成 [13] 公司战略和发展方向及行业竞争 - 公司将FILSPARI定位为IgA肾病的基础治疗,未来有望替代RAS抑制剂 [15][16][20] - 公司正在与FDA合作,推进FILSPARI在FSGS适应症的开发 [23][24] - 公司正在推进罕见病新药pegtibatinase的III期临床试验,预计2026年获得数据 [25] 管理层对经营环境和未来前景的评论 - 管理层对FILSPARI的发展前景充满信心,认为有望进一步扩大适应症范围,增加可覆盖的患者人群 [12][32] - 管理层认为KDIGO指南的更新以及FILSPARI标签的扩大将为FILSPARI的进一步增长提供有力支撑 [34][93] 其他重要信息 - 公司正在与FDA就FILSPARI的REMS要求进行沟通,未来可能会申请修改或取消REMS [46][47] - 公司正在关注PARASOL小组就FSGS新的临床终点指标的研究进展,并计划与FDA进一步沟通 [88][89][97] 问答环节重要的提问和回答 问题1 **Tyler Van Buren 提问** 关于FILSPARI REMS要求的修改,公司有何预期? [45][46] **Eric Dube 回答** 公司正在与FDA就REMS要求进行沟通,目前还没有先例可循,公司正在评估多种情况 [46][47] 问题2 **Anupam Rama 提问** FILSPARI新增患者启动表单中,新开方医生和老患者占比如何变化? [49] **Peter Heerma 回答** 新开方医生和老患者占比增长基本持平,符合成功产品的发展轨迹 [51] 问题3 **Jula Inrig 回答** 公司正在关注PARASOL小组就FSGS新的临床终点指标的研究进展,并计划与FDA进一步沟通 [97][98][99]

For the quarter ended June 2024, Travere Therapeutics (TVTX) reported revenue of $54.12 million, down 9.4% over the same period last year. EPS came in at -$0.90, compared to -$1.13 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $49.5 million, representing a surprise of +9.33%. The company delivered an EPS surprise of -3.45%, with the consensus EPS estimate being -$0.87.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings - ...

Travere Therapeutics (TVTX) came out with a quarterly loss of $0.90 per share versus the Zacks Consensus Estimate of a loss of $0.87. This compares to loss of $1.13 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -3.45%. A quarter ago, it was expected that this drug developer would post a loss of $0.98 per share when it actually produced a loss of $1.76, delivering a surprise of -79.59%.Over the last four quarters, the company ...