Nintedanib esylate

FAYETTEVILLE, NY, UNITED STATES, January 9, 2026 / EINPresswire.com / -- January is traditionally a peak period for pharmaceutical list price adjustments. The AnalySource team analyzed Wholesale Acquisition Cost (WAC) package pricing changes for all single-source prescription products with effective dates surrounding the new year, spanning December 1, 2025 through February 28, 2026. Overall, the analysis shows that most price changes were modest, though a limited number of notable outliers were observed. The analysis encompassed 1,902 National Drug Codes (NDCs) representing all identified single-source products with WAC package pricing changes during the analysis period. Only a small subset exhibited material pricing movement, with 11 drugs, some with various formulations, reporting WAC package price decreases and 31 products recording WAC package price increases of 10% or greater. These findings underscore that large price movements remain the exception rather than the norm, even during peak annual pricing cycles. Several significant outliers stood out in the data. Sandoz’s CIMERLI reported an 85.29% decrease in WAC package price, representing the largest reduction observed during the period. The largest WAC package price increase in the dataset was reported by PAI Holdings for TRIHEXYPHENIDYL (+480%). In addition, the most extreme WAC package price increases were highly concentrated within a small number of manufacturers, with Hospira/Pfizer accounting for the majority of increases exceeding 300%, including Verapamil HCl (+377%), Lorazepam (+346%), Naloxone HCl (+334%), and Hydromorphone HCl (+318%). These products are commonly used in hospital and acute care settings, where pricing dynamics may differ from those of outpatient or retail-dispensed therapies. Other notable movements included Sprout Pharmaceuticals, which reported a 110.64% increase for ADDYI, a branded product indicated for sexual function disorders. Novo Nordisk implemented substantial price decreases across multiple insulin products, including Fiasp and Tresiba presentations, reflecting a coordinated portfolio-level pricing adjustment rather than isolated product changes. Several manufacturers exhibited mixed pricing strategies within their portfolios. Boehringer Ingelheim reported modest price increases for products such as Ofev, Pradaxa, and Gilotrif while simultaneously implementing price decreases of approximately 44% for several other products. Pfizer reported both significant price increases across select hospital and specialty products and a price decrease for Xeljanz, a therapy used in inflammatory conditions. Outside of these exceptions, most manufacturers reported modest WAC package price increases in the range of 2% to 6%, consistent with historical annual pricing patterns. Across therapeutic areas, these adjustments align with routine pricing activity that may reflect product lifecycle stage, competitive dynamics, manufacturing considerations, and regulatory developments. While additional list price adjustments are expected later in the pricing cycle, early indications suggest that the majority of products will continue to reflect modest pricing changes, with large increases and decreases remaining relatively limited. The AnalySource team will continue to monitor these developments closely and will provide further updates as additional information becomes available. Daniel Miccio DMD America, Inc. +1 315-400-2289 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Pooled patients treated with TTI-101 demonstrated a 9.4% decrease from baseline in fibrosis score at week 12, compared to a 2.4% decrease for the placebo group Topline healthy volunteer data from Phase 1 study of next-generation STAT3 inhibitor, TTI-109, on track for H1 2026 HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today 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. Additional analysis was conducted to interrogate the impact of STAT3 inhibition using TTI-101 on fibrosis, inflammatory markers and pulmonary function. In order to do so, the additional analysis was limited to patients who were exposed to study drug for 12 weeks. Upon interrogation of pharmacokinetics and adverse events, one patient was removed from the analysis due to receiving less than 60% of the expected dosing; two patients were removed due to no measurable TTI-101 observed in the blood as well as no reported adverse events; and one additional patient was removed as an outlier for the 12-week analysis as their pulmonary function initially improved on treatment, but was subsequently severely impacted by acute bronchitis deemed unrelated to study drug. This resulted in a dataset of 40 patients analyzed: 16 pooled patients treated with TTI-101, and 24 patients treated with placebo. Data highlights: Fibrosis: Fibrosis decline was greater in patients treated with TTI-101 compared to placebo, -9.4% vs -2.4%, respectively, in baseline-weighted high resolution CT lung fibrosis score (centrally read, blinded and independently assessed). Inflammation: A greater IL-6 decline was observed among TTI-101-treated patients vs placebo. In addition, greater reduction in IL-6 was observed among patients with higher baseline IL-6 in the TTI-101-treated patients. IL-6 is a key pro-inflammatory cytokine that signals through STAT3. Inhibition of STAT3 is expected to reduce downstream inflammatory signaling associated with disease. 63% of pooled patients treated with TTI-101 demonstrated an increase in FVC at 12 weeks, compared to 46% of the placebo group. Mean FVC change in TTI-101-treated patients was -15mL; less of a decline when compared to the REVERT placebo (-22mL) and historical placebo groups from comparable IPF trials. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “Our subsequent analyses of the REVERT IPF clinical trial data set revealed deeper insights into the impact of TTI-101 on the inhibition of STAT3 in fibrosis and inflammation. Notably, treatment with TTI-101 was associated with improvement in blinded fibrosis scores vs placebo and reductions in IL-6 levels consistent with STAT3 pathway inhibition. Further interrogation into FVC after 12 weeks of TTI-101 was encouraging despite the placebo-treated patients’ FVC decline being lower than expected compared to historical controls. “With these data in-hand, we eagerly await results from the ongoing healthy volunteer study of our next-generation STAT3 inhibitor, TTI-109. TTI-109 is designed to enhance TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability. If successful, we will move quickly to identify next steps for this promising, potentially disease modifying therapy across a range of fibrosis-driven diseases where STAT3 activation is implicated.” The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial of TTI-101 alone or in addition to nintedanib (OFEV ® ) in patients with IPF. The study was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function. Tvardi announced on October 13, 2025 that the study did not meet its goals after reviewing preliminary safety data and efficacy results. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting clinical trials with TTI-101 in hepatocellular carcinoma (NCT05440708) and TTI-109 in healthy volunteers. To learn more, please visit tvardi.com or follow us on LinkedIn and X (Twitter). Contacts: For Tvardi: Tvardi Investor Relations ir@tvardi.com PJ Kelleher LifeSci Advisors 617-430-7579 pkelleher@lifesciadvisors.com Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.