Novartis announced on September 4, 2026, that its Phase III Lp(a)HORIZON trial for pelacarsen did not meet its primary endpoint. The study failed to demonstrate a reduction in cardiovascular events compared to placebo.

The trial evaluated pelacarsen, an investigational antisense oligonucleotide licensed from Ionis Pharmaceuticals, in patients with elevated lipoprotein (a) and established cardiovascular disease. Despite achieving lower Lp(a) levels, the drug did not translate this biomarker reduction into improved clinical outcomes for the overall population.

Trial Design and Results

Lp(a)HORIZON was a randomized, placebo-controlled, double-blind global study involving 8,323 patients. The primary endpoint measured a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization.

Participants were receiving guideline-directed treatments, including lipid-lowering and antihypertensive therapies. The study assessed outcomes in two groups: the overall population with Lp(a) levels ≥70 mg/dL and a subpopulation with levels ≥90 mg/dL.

What the Numbers Show

The data reveals a divergence between pharmacological efficacy and clinical benefit. While pelacarsen successfully inhibited Lp(a) production at its source, resulting in lower biomarker levels, this reduction did not correlate with a decrease in major adverse cardiovascular events. This suggests that simply lowering Lp(a) may not be sufficient to reduce residual cardiovascular risk in patients already on optimized care.

Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, stated that the findings provide important evidence on the relationship between Lp(a) lowering and cardiovascular outcomes. Brett P. Monia, CEO of Ionis, noted that while the study did not meet its primary endpoint, the results provide clarity that will meaningfully inform future cardiovascular care.

Future Steps

Novartis plans to present the Lp(a)HORIZON data at an upcoming medical congress. The company emphasized its continued commitment to cardiovascular innovation despite the negative results. Pelacarsen remains an investigational therapy with no approved targeted treatment currently available for elevated Lp(a). Ionis continues to drive the independent commercialization of its wholly owned medicines TRYNGOLZA, DAWNZERA and ZANVASTRO.

Novartis India Limited has submitted its Business Responsibility and Sustainability Report (BRSR) to the Bombay Stock Exchange for the financial year ended March 31, 2026.

The filing outlines the company’s performance against the nine principles of the National Guidelines on Responsible Business Conduct (NGRBC). As a trading entity without manufacturing facilities, Novartis India focuses its disclosures on office operations, supply chain ethics, and stakeholder engagement rather than industrial production metrics.

Operational and Environmental Metrics

The company reported a significant reduction in energy consumption during FY26 compared to the previous year. Total energy consumed fell from 1,310.0 GJ in FY25 to 290.02 GJ in FY26. This decline was driven by a sharp drop in non-renewable electricity consumption, which decreased from 1,310.0 GJ to 60.02 GJ. Renewable electricity consumption was recorded at 230 GJ for the period January 2025 to December 2025.

Greenhouse gas emissions also saw a marked decrease. Total Scope 2 emissions dropped from 277.4 metric tonnes of CO2 equivalent in FY25 to 12.3 metric tonnes in FY26. Scope 1 emissions were not tracked. The reduction in Scope 2 emissions aligns with initiatives such as transitioning local logistics from air to surface freight, which the company states reduced transportation-related emissions by over 70% in 2025 compared to 2024.

Employee Welfare and Governance

Novartis India employed 59 individuals as of March 31, 2026, comprising 57 permanent employees and 2 non-permanent staff. The workforce included 48 males and 11 females. The company reported a 0% turnover rate for permanent employees in FY26, down from 7% in FY25 and 11% in FY24.

The Board of Directors consists of six members, with three women representing 50% of the board. Key Management Personnel includes three individuals, two of whom are female (66.66%). All permanent employees received training on health, safety, and skill upgradation, achieving 100% coverage.

Regulatory and Stakeholder Engagement

The report disclosed several regulatory proceedings. The Income Tax Department proposed an adjustment of approximately ₹33.83 million regarding transfer pricing issues for the assessment year 2022-23; the company has appealed this order. Additionally, a demand of ₹10.28 crore was raised under Section 156 of the Income-tax Act for TDS defaults in AY 2020-21, which is also under appeal.

Stakeholder complaints were minimal. The company received 19 shareholder complaints, with one pending resolution at year-end. Customer complaints totaled 15, with seven pending. No complaints were received regarding sexual harassment, discrimination, or child labour.

What the Numbers Show

The divergence between total waste generated and hazardous waste disposal highlights the operational nature of the entity. While total waste increased from 39.6 metric tonnes in FY25 to 48.9 metric tonnes in FY26, hazardous waste incineration dropped significantly from 36.1 metric tonnes to 17.5 metric tonnes. This suggests a shift in waste composition or improved segregation practices, as plastic waste (26.5 metric tonnes) appeared in FY26 data where it was nil previously.