Bausch Health Cos., Inc. engages in the development, manufacture and market of a range of branded, generic and branded generic pharmaceuticals, medical devices and over-the-counter products. It operates through the following segments: Salix, International, Solta Medical, Diversified Products, and Bausch + Lomb. The Salix segment consists of sales in the U.S. of GI products. Sales of the Xifaxan product line. The International segment comprises of sales, except for sales of Bausch + Lomb products and Solta aesthetic medical devices, outside the U.S and Puerto Rico of branded pharmaceutical products, branded generic pharmaceutical and OTC products. The Solta Medical segment refers to global sales of Solta Medical aesthetic medical devices. The Diversified Products segment covers sales in the U.S. of pharmaceutical products in the areas of neurology and certain other therapeutic classes, generic products, ortho dermatologic, and dentistry products. The Bausch + Lomb segment are global sales of Bausch + Lomb vision care, surgical and ophthalmic pharmaceuticals products. The company was founded on March 29, 1994, and is headquartered in Laval, Canada.
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- The alcohol-associated liver disease market across the 7MM was valued at USD 145 million in 2025, with the United States accounting for approximately 59% of the total market share. - No FDA-approved therapies currently exist that directly modify ALD disease progression, leaving liver transplantation as the only curative option for end-stage disease. - Bausch Health's larsucosterol, holding FDA Fast Track and Breakthrough Therapy designations, entered Phase III trials in early 2026 with topline results expected in 2028 and potential approval by early 2029. - Emerging pipeline candidates including GSK4532990 (GSK), INT-787 (Alfasigma), Pemvidutide (Altimmune), and NTR-101 (Nterica) are targeting metabolic dysfunction, inflammation, and fibrosis through diverse modalities such as RNAi, FXR agonism, and GLP-1/glucagon dual agonism.
- Xenon Pharmaceuticals' azetukalner demonstrated a 53.2% reduction in seizures among treatment-resistant epilepsy patients, representing the highest placebo-adjusted efficacy ever observed in a pivotal epilepsy study. - The late-stage trial of 380 patients showed 55% of participants experienced at least a 50% reduction in seizure activity, with the drug outperforming placebo by 42.7 percentage points over 12 weeks. - Xenon plans to submit a new drug application to the FDA in the second half of 2026, potentially bringing the 15th B.C.-developed therapy to market for the 3 million Americans living with epilepsy.
- George Medicines has secured exclusive licensing agreements with Orient EuroPharma for Southeast Asia and Arrotex Pharmaceuticals for Australia and New Zealand to commercialize GMRx2, an innovative triple-combination hypertension therapy. - GMRx2 combines telmisartan, amlodipine, and indapamide in a single pill with three dosage options, including two lower-dose formulations designed to deliver triple therapy benefits early in treatment with established safety profiles. - The drug demonstrated significant blood pressure reduction and improved control rates in Phase III trials published in the Journal of the American College of Cardiology and The Lancet, with good tolerability and no increased treatment withdrawals. - These partnerships expand GMRx2's global footprint to include markets where hypertension control rates remain suboptimal, with only half of Australian patients and a quarter of New Zealand patients achieving effective blood pressure control.
- Bausch Health's new solid soluble dispersion formulation of rifaximin failed to meet primary endpoints in two Phase III trials for preventing hepatic encephalopathy in liver cirrhosis patients. - The RED-C trials enrolled over 1,000 patients across 17 countries but did not demonstrate significant delay in first onset of overt hepatic encephalopathy compared to placebo. - The failure represents a major setback for Bausch Health as analysts had projected the new formulation could generate $2 billion annually, with Xifaxan currently contributing 85% of Salix's $1.89 billion revenue. - Company shares dropped more than 10% following the announcement, highlighting investor concerns about pipeline gaps as Xifaxan faces patent expiration around 2029.
- Bausch Health Companies reported that its global Phase 3 RED-C program for hepatic encephalopathy prevention failed to meet its primary endpoint, representing a significant clinical setback. - The trial failure leaves the company without a clear successor to its blockbuster drug Xifaxan, raising concerns about future revenue growth prospects. - Despite the clinical disappointment, analysts suggest the stock may be undervalued at $5.91 compared to a fair value estimate of $7.43. - The company faces additional challenges from potential Medicare price cuts for Xifaxan and a substantial debt burden of $16.1 billion.
- Bausch Health announced that its global Phase 3 RED-C clinical program evaluating rifaximin SSD for hepatic encephalopathy prevention in liver cirrhosis patients failed to meet the primary endpoint. - The program consisted of two randomized, double-blind, placebo-controlled trials involving more than 1,000 patients across 398 sites in 17 countries. - Despite the failure, the treatment was found to be safe and well-tolerated, with the company reviewing the dataset for potential new development opportunities. - The results represent a setback for patients with liver cirrhosis, as there is currently no approved treatment for primary prevention of hepatic encephalopathy.
- Bausch Health announced the acquisition of DURECT Corporation for $63 million upfront, with potential milestone payments up to $350 million, to gain access to larsucosterol, an epigenetic modulator with FDA Breakthrough Therapy Designation for alcoholic hepatitis. - Larsucosterol represents a potential first-in-class treatment for alcoholic hepatitis, a life-threatening condition responsible for approximately 100 deaths per day in the US and 164,000 hospital admissions in 2021, with no currently approved therapies. - The acquisition strengthens Bausch Health's hepatology portfolio alongside their ongoing Phase 3 rifaximin SSD program, with a registrational Phase 3 trial for larsucosterol planned to evaluate 90-day survival in severe alcoholic hepatitis patients.
- A comprehensive seven-year US pharmacovigilance analysis of brodalumab covering 5,449 patients and 7,845 patient-years of exposure shows no completed suicides and only one suicide attempt in year 3. - The study confirms brodalumab's consistent safety profile with arthralgia remaining the most common adverse event (140 cases) and low rates of serious infections (2.17/100 patients) compared to other biologic therapies. - Adverse event rates for major safety concerns including cardiovascular events (0.24/100 patients), malignancy (1.01/100 patients), and inflammatory bowel disease (0.06/100 patients) remained lower than comparative registry data. - The analysis reinforces that brodalumab maintains good tolerability with no new safety signals emerging during the extended monitoring period despite its boxed warning for suicidal ideation.
- Tharimmune announced key leadership changes with Sireesh Appajosyula becoming CEO and Vincent LoPriore appointed Executive Chairman in June 2025. - The company added James Gordon Liddy, a retired Navy SEAL Commander with national security expertise, to its board of directors to support TH104 development. - TH104 is a buccal film formulation designed to deliver opioid antagonist therapy for military personnel and first responders exposed to weaponized fentanyl and high-potency opioids. - The leadership appointments strengthen Tharimmune's strategic position as it advances its lead candidate through the 505(b)2 regulatory pathway for respiratory and nervous system depression prevention.
- Bausch Health Companies Inc. and Mylan Pharmaceuticals have reached a settlement agreement resolving their patent litigation over generic versions of irritable bowel syndrome (IBS) medications. - The settlement likely includes licensing terms allowing Mylan to market generic versions of Bausch's IBS drugs after specific dates, though exact terms remain confidential. - This agreement represents a significant development in the gastrointestinal pharmaceutical market, potentially increasing future access to affordable IBS treatments.
