TVTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• 5As part of the ongoing basket study conducted by Everest Medicines.

• In the Phase 3 DUPLEX Study, the largest head-to-head interventional study in FSGS to date, patients treated with FILSPARI in the overall study population experienced a statistically significant 46% reduction in proteinuria from baseline to Week 108 compared to 30% for those treated with maximum lab…

• In September 2024, we announced a voluntary pause of enrollment in the Phase 3 HARMONY Study. The voluntary enrollment pause was enacted following our determination that the desired drug substance profile was not achieved in the initial scale-up process, and it enabled us to address necessary proces…

• successful process improvements, the Company restarted enrollment activities in the first quarter of 2026 and dosed the first new patient following study restart in April 2026, with topline data anticipated in the second half of 2027.

• Civorebrutinib is an investigational oral, covalent reversible Bruton’s tyrosine kinase (“BTK”) inhibitor designed to provide differentiated efficacy, safety and convenience for patients with rare, immune-mediated kidney diseases, including primary membranous nephropathy (“PMN”), with planned evalua…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• In the Phase 3 DUPLEX Study, the largest head-to-head interventional study in FSGS to date, patients treated with FILSPARI in the overall study population experienced a statistically significant 46% reduction in proteinuria from baseline to Week 108 compared to 30% for those treated with maximum lab…

• irbesartan (nominal p-value, 0.0299). In patients without nephrotic syndrome, FILSPARI demonstrated even greater improvements compared to maximum labeled dose irbesartan across proteinuria and eGFR. Those without nephrotic syndrome who were treated with FILSPARI experienced a 48% reduction in protei…

• In September 2024, we announced a voluntary pause of enrollment in the Phase 3 HARMONY Study. The voluntary enrollment pause was enacted following our determination that the desired drug substance profile was not achieved in the initial scale-up process, and it enabled us to address necessary proces…

• The decrease in license and collaboration revenue for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to the sale of $3.8 million in active pharmaceutical ingredients ("API") to CSL Vifor during the three months ended March 31, 2025.

• Cost of goods sold - license and collaboration— 3,426 (3,426)

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• If we are unable to maintain an effective sales force for our products, including the recently expanded sales force for FILSPARI or any other potential future approved products, we may not be able to generate sufficient product revenue in the United States. In addition, until the commencement of our…

• We have granted exclusive licenses to third parties for the commercialization of sparsentan in certain territories outside of the United States, including Europe, Australia, New Zealand, Japan, South Korea, Taiwan, Brazil, Chile, Israel and the Gulf Cooperation Council Countries. If these third part…

• effectively engage or maintain their sales force for sparsentan if approved in the applicable territories, our ability to recognize milestone payments and royalties from the sales in such territories will be adversely affected.

• Based on the complex relationships between the United States and certain foreign countries, there is inherent risk that political, diplomatic and national security influences might lead to trade disputes and impacts and/or disruptions to our third-party manufacturers and product supply. There is cur…

• changes with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. We currently source products and various materials that are necessary for the manufacturing of our products from countries that are subject to tariffs, and any changes in tariffs, trad…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• If we are unable to maintain an effective sales force for our products, including the recently expanded sales force for FILSPARI or any other potential future approved products, we may not be able to generate sufficient product revenue in the United States. In addition, until the commencement of our…

• launch in IgAN in February 2023, and in FSGS in April 2026, no one in our sales force had promoted FILSPARI for the treatment of IgAN or FSGS patients, respectively. We are required to expend significant time and resources to train our sales force to be credible in educating physicians and pharmacis…

• We have granted exclusive licenses to third parties for the commercialization of sparsentan in certain territories outside of the United States, including Europe, Australia, New Zealand, Japan, South Korea, Taiwan, Brazil, Chile, Israel and the Gulf Cooperation Council Countries. If these third part…

• under which generic companies can bring suit against companies who refuse access to product for the bioequivalence testing needed to support approval of a generic product.

• Based on the complex relationships between the United States and certain foreign countries, there is inherent risk that political, diplomatic and national security influences might lead to trade disputes and impacts and/or disruptions to our third-party manufacturers and product supply. There is cur…

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• During the fiscal quarter ended June 30, 2026, certain of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408, as set…

• Name & TitleDate AdoptedCharacter of Trading Arrangement (1)Aggregate Number of Shares of Common Stock to be Sold Pursuant to Trading ArrangementExpiration Date (2)

• Chief Legal Officer, General Counsel and Corporate Secretary

• 1Each trading arrangement marked as a “Rule 10b5-1 Trading Arrangement” is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act (the “Rule”).

• 2Each trading arrangement permits transactions through and including the earlier to occur of (a) the completion of all sales and (b) the date listed in the table. Each trading arrangement marked as a “Rule 10b5-1 Trading Arrangement” only permits transactions upon expiration of the applicable mandat…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• During the fiscal quarter ended March 31, 2026, none of our directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Regulation S-K, Item 408.