BridgeBio has revealed new pivotal trial data for Attruby (acoramidis) along with results from an indirect comparison to Pfizer’s Vyndamax (tafamidis), as the former company looks to continue establishing market share in the transthyretin amyloid cardiomyopathy (ATTR-CM) market.
In a late-breaking oral presentation at the European Society of Cardiology’s (ESC) ongoing 2026 Heart Failure conference, the company debuted new data from the Phase III ATTRibute-CM (NCT03860935) study, which is evaluating the efficacy and safety of the pill.
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The US Food and Drug Administration (FDA) approved Attruby for the treatment of ATTR-CM in November 2024.
During the study, twice-daily treatment with Attruby boosted and maintained levels of wild-type transthyretin by day 28 through to month 30, which is the protein that causes ATTR-CM when misfolded. Patients treated with the drug also experienced a significant drop in the variability of blood transthyretin levels over placebo – mediating 20% of Attruby’s significant positive impact on the risk of all-cause mortality.
According to Duke University School of Medicine’s Dr Senthil Selvaraj, these results highlight that reducing transthyretin variability on an individual level may be important in modifying disease outcomes. “By linking transthyretin variability independently to mortality, we’re seeing a mechanistic signal that may help explain Attruby’s clinical benefit,” Selvaraj said.
European licensing partner Bayer, which markets the drug under the name Beyonttra, also obtained results that demonstrated the medicine’s potential to improve patient outcomes, as treatment diminished the risk of outpatient worsening heart failure by 40% versus placebo – a strong predictive factor for death and hospitalisation in ATTR-CM.
Attruby shows potential to best SoC
Alongside the new data around Attruby’s mechanism and impact on patient outcomes, am indirect comparison has revealed that the drug could potentially best the patient outcomes in ATTR-CM offered by Pfizer’s mainstay SoC therapy, Vyndamax.In Europe, the drug is marketed as Vyndaqel.
According to the matching-adjusted indirect comparison based on the ATTRibute-CM study, Attruby led to a significant, 34% reduction in cardiovascular hospitalisations versus Pfizer’s drug, while maintaining a comparable safety profile.
BridgeBio’s drug also demonstrated a favourable mortality trend, exhibiting a 28% hazard reduction in all-cause mortality versus tafamidis. However, it must be noted that BridgeBio has not conducted a head-to-head study against Vyndamax. This means that researchers cannot yet draw any full conclusions on the comparability between the two drugs.
These results come amid a period of positive revenue growth of Attruby, with the drug surpassing analyst expectations by generating $180.6m in Q1 revenues – up 24% from the same quarter in 2025.
In a research note, William Blair analysts said: “The fundamentals are all aligning here, with Attruby outperforming expectations in the quarter as it is capturing a strong and growing percentage of first-line usage, meaningful second-line usage despite sharing a mechanism of action with first-line Vyndamax, and combination usage with a knockdown therapy close to parity with Vyndamax.”
Currently, Attruby, Vyndamax and Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) are the only drugs that have secured the US regulatory go-ahead in ATTR-CM, though drugs by Ionis Pharmaceuticals, Novo Nordisk and Intellia Therapeutics are currently making their way through the late-stage pipeline.
In a significant moment for the ATTR-CM’s near-term future, Pfizer reached settlements with several pharma companies who were planning to market generics of Vyndamax. The agreements, made in late April, pushed back US patent expiry for Vyndamax to 2031. Analysts viewed the proceedings as a mixed outcome for BridgeBio.
