Tvardi Therapeutics (TVRD) FDA Approvals $2.35 -0.07 (-2.89%) Closing price 04:00 PM EasternExtended Trading$2.36 +0.01 (+0.43%) As of 05:44 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsTrendsBuy This Stock Tvardi Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Tvardi Therapeutics (TVRD). Over the past two years, Tvardi Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TTI-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. TTI-101 FDA Regulatory Timeline and Events TTI-101 is a drug developed by Tvardi Therapeutics for the following indication: In Idiopathic Pulmonary Fibrosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - January 8,2026Provided Update Drug: TTI-101Announced Date: January 8, 2026Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). Preliminary results were announced on October 13, 2025.AI SummaryTvardi updated its Phase 2 REVERT IPF trial of TTI-101; preliminary results were announced October 13, 2025. An additional analysis limited to patients on study drug for 12 weeks excluded four patients for low dosing, undetectable drug, or unrelated bronchitis, leaving 40 patients (16 TTI-101, 24 placebo). On high-resolution CT, TTI-101 patients showed a 9.4% decrease from baseline in fibrosis score at week 12, versus a 2.4% decrease for placebo. TTI-101 also produced larger IL-6 reductions than placebo, especially in patients with higher baseline IL-6. At 12 weeks, 63% of TTI-101 patients had improved FVC versus 46% of placebo. Mean FVC change was −15 mL for TTI-101 versus −22 mL for REVERT placebo and similar to historical controls. Tvardi said these results suggest STAT3 inhibition may reduce fibrosis and inflammation and support further study.Read AnnouncementProvided Update - October 13,2025Provided Update Phase 2Drug: TTI-101Announced Date: October 13, 2025Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).AI SummaryTvardi Therapeutics provided an update on preliminary data from its Phase 2 REVERT trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). The randomized, double-blind study compared 400 mg and 800 mg daily doses versus placebo, with or without nintedanib. Of 88 patients, discontinuations were higher in the TTI-101 arms (56.7% at 400 mg, 62.1% at 800 mg) versus placebo (10.3%), mainly due to gastrointestinal side effects, especially when combined with nintedanib. Baseline lung function was similar across treated groups but slightly lower in the placebo arm. Exploratory analysis of Forced Vital Capacity (FVC) showed no significant differences between groups: 41% of placebo patients and 39–44% of treated patients improved from baseline. FVC changes overlapped across arms, and the placebo group’s decline was lower than expected. Tvardi concluded the trial did not meet its goals and will conduct further analyses before deciding next steps.Read AnnouncementEnrollment Completion - May 27,2025Enrollment Completion Phase 2Drug: TTI-101Announced Date: May 27, 2025Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc announced that it has completed enrollment for its lead program in a Phase 2 clinical trial of TTI-101 for patients with idiopathic pulmonary fibrosis (IPF).AI SummaryTvardi Therapeutics, Inc. announced a major milestone by completing enrollment for its lead program in a Phase 2 clinical trial, REVERT IPF, which is testing TTI-101 for patients with idiopathic pulmonary fibrosis (IPF). TTI-101 is an oral small molecule that targets STAT3, a key player in the fibrotic signaling pathways that contribute to the progression of IPF—a chronic, debilitating lung disease with a high unmet need for effective treatments. The REVERT IPF trial is randomized, double-blind, and placebo-controlled, focusing on assessing both safety and lung function improvements through measurements such as forced vital capacity (FVC). Tvardi’s CEO highlighted the trial’s potential, noting that TTI-101’s dual action could reduce lung fibrosis and restore lung function. Topline data from the trial are anticipated in the fourth quarter of 2025.Read Announcement Tvardi Therapeutics FDA Events - Frequently Asked Questions Has Tvardi Therapeutics received FDA approval? As of now, Tvardi Therapeutics (TVRD) has not received any FDA approvals for its therapy in the last two years. What drugs has Tvardi Therapeutics submitted to the FDA? In the past two years, Tvardi Therapeutics (TVRD) has reported FDA regulatory activity for TTI-101. What is the most recent FDA event for Tvardi Therapeutics? The most recent FDA-related event for Tvardi Therapeutics occurred on January 8, 2026, involving TTI-101. The update was categorized as "Provided Update," with the company reporting: "Tvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). Preliminary results were announced on October 13, 2025." What conditions do Tvardi Therapeutics' current drugs treat? Currently, Tvardi Therapeutics has one therapy (TTI-101) targeting the following condition: In Idiopathic Pulmonary Fibrosis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Cybin FDA EventsREGENXBIO FDA EventsViking Therapeutics FDA EventsWAVE Life Sciences FDA EventsMerck & Co., Inc. FDA EventsAgomAb Therapeutics FDA EventsAmylyx Pharmaceuticals FDA EventsCoherus Oncology FDA EventsDiaMedica Therapeutics FDA EventsEntera Bio FDA EventsGalectin Therapeutics FDA EventsGilead Sciences FDA EventsJaguar Animal Health FDA EventsKalaris Therapeutics FDA EventsMicrobot Medical FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Rani Therapeutics FDA Events Verrica Pharmaceuticals FDA Events Black Diamond Therapeutics FDA Events Atara Biotherapeutics FDA Events Aardvark Therapeutics FDA Events Biomea Fusion FDA Events Cardiff Oncology FDA Events Gain Therapeutics FDA Events Cypherpunk Technologies FDA Events Rein Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TVRD last updated on 1/8/2026 by MarketBeat.com Staff. 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Provided Update - January 8,2026Provided Update Drug: TTI-101Announced Date: January 8, 2026Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). Preliminary results were announced on October 13, 2025.AI SummaryTvardi updated its Phase 2 REVERT IPF trial of TTI-101; preliminary results were announced October 13, 2025. An additional analysis limited to patients on study drug for 12 weeks excluded four patients for low dosing, undetectable drug, or unrelated bronchitis, leaving 40 patients (16 TTI-101, 24 placebo). On high-resolution CT, TTI-101 patients showed a 9.4% decrease from baseline in fibrosis score at week 12, versus a 2.4% decrease for placebo. TTI-101 also produced larger IL-6 reductions than placebo, especially in patients with higher baseline IL-6. At 12 weeks, 63% of TTI-101 patients had improved FVC versus 46% of placebo. Mean FVC change was −15 mL for TTI-101 versus −22 mL for REVERT placebo and similar to historical controls. Tvardi said these results suggest STAT3 inhibition may reduce fibrosis and inflammation and support further study.Read Announcement
Provided Update - October 13,2025Provided Update Phase 2Drug: TTI-101Announced Date: October 13, 2025Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).AI SummaryTvardi Therapeutics provided an update on preliminary data from its Phase 2 REVERT trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). The randomized, double-blind study compared 400 mg and 800 mg daily doses versus placebo, with or without nintedanib. Of 88 patients, discontinuations were higher in the TTI-101 arms (56.7% at 400 mg, 62.1% at 800 mg) versus placebo (10.3%), mainly due to gastrointestinal side effects, especially when combined with nintedanib. Baseline lung function was similar across treated groups but slightly lower in the placebo arm. Exploratory analysis of Forced Vital Capacity (FVC) showed no significant differences between groups: 41% of placebo patients and 39–44% of treated patients improved from baseline. FVC changes overlapped across arms, and the placebo group’s decline was lower than expected. Tvardi concluded the trial did not meet its goals and will conduct further analyses before deciding next steps.Read Announcement
Enrollment Completion - May 27,2025Enrollment Completion Phase 2Drug: TTI-101Announced Date: May 27, 2025Indication: In Idiopathic Pulmonary FibrosisAnnouncementTvardi Therapeutics, Inc announced that it has completed enrollment for its lead program in a Phase 2 clinical trial of TTI-101 for patients with idiopathic pulmonary fibrosis (IPF).AI SummaryTvardi Therapeutics, Inc. announced a major milestone by completing enrollment for its lead program in a Phase 2 clinical trial, REVERT IPF, which is testing TTI-101 for patients with idiopathic pulmonary fibrosis (IPF). TTI-101 is an oral small molecule that targets STAT3, a key player in the fibrotic signaling pathways that contribute to the progression of IPF—a chronic, debilitating lung disease with a high unmet need for effective treatments. The REVERT IPF trial is randomized, double-blind, and placebo-controlled, focusing on assessing both safety and lung function improvements through measurements such as forced vital capacity (FVC). Tvardi’s CEO highlighted the trial’s potential, noting that TTI-101’s dual action could reduce lung fibrosis and restore lung function. Topline data from the trial are anticipated in the fourth quarter of 2025.Read Announcement
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