文章核心观点 - 公司的主要产品Filspari获得FDA全面批准,成为治疗原发性IgA肾病的唯一非免疫抑制药物,这可能是推动公司股价最近上涨的主要原因 [1][2] - 公司预计在即将发布的财报中将录得亏损,但营收预计同比增长60.2% [3] - 公司的盈利预测已在过去30天内上调1.8%,这通常会带来股价上涨 [4] 行业和公司概况 - 公司属于医疗-生物医药和遗传学行业,同行业另一家公司Orchestra BioMed Holdings, Inc.最近一个月股价下跌15.4% [4] - Orchestra BioMed Holdings, Inc.即将发布的财报每股收益预测在过去一个月内保持不变,同比下降15.8% [5]

调查事件 - Bronstein Gewirtz & Grossman LLC正在代表Travere Therapeutics Inc（纳斯达克股票代码：TVTX）的购买者调查潜在索赔事件 投资者可通过访问bgandg.com/TVTX获取更多信息并协助调查 [1] 调查详情 - 2024年9月26日Travere发布新闻稿宣布自愿暂停评估pegtibatinase治疗经典同型半胱氨酸尿症（HCU）的3期HARMONY研究的注册 公司表示自愿注册暂停使公司能够致力于解决扩大生产规模所需的流程改进以支持商业规模生产以及HARMONY研究的全面注册 且在公司确定近期扩大生产过程中未达到预期的原料药特性后实施了自愿注册暂停 [2] - 此消息发布后Travere的股价在2024年9月27日每股下跌1.03美元 即6.85% 收于每股14.01美元 [2] 后续行动 - 若知晓与此次调查相关的任何事实或购买了Travere证券 可通过访问bgandg.com/TVTX协助调查 也可联系Bronstein Gewirtz & Grossman LLC的Peretz Bronstein或其客户关系经理Nathan Miller 电话：332 - 239 - 2660 [3]

Travere Therapeutics, Inc. (NASDAQ: TVTX ) specializes in treatments for rare kidney and metabolic diseases. TVTX's portfolio includes FDA-approved drugs like Filspari [Sparsentan] for IgA Nephropathy [IgAN] and Thiola [Tiopronin] for cystinuria. Filspari received full FDA approval in September 2024, expanding its label and expanding patient access. However, its Phase My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Naciona ...

SAN DIEGO, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced a voluntary pause of enrollment in the Phase 3 HARMONY Study evaluating pegtibatinase for the treatment of classical homocystinuria (HCU). The voluntary enrollment pause enables the Company to work to address necessary process improvements in manufacturing scale-up to support commercial scale manufacturing as well as full enrollment in the HARMONY Study. Patients currently enrolled in pegtibatinase studi ...

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 nonimmunosuppressive 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 nonimmunosuppressive 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 headto-head trial conducted in IgAN As an or ...

Chris Ryan/OJO Images via Getty Images Investment 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 signific ...

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 Conference Tuesday, August 13, 2024, at 2:30 p.m. ET Canaccord Genuity 44th Annual Growth Conference Wednesday, 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 ...