BridgeBio Pharma: данные МРТ указывают на улучшение структуры сердца при ATTR-кардиомиопатии, но «обратимость» болезни пока не доказана

BridgeBio Pharma, Inc. (NASDAQ:BBIO) is asking investors to look beyond disease stabilization in transthyretin amyloid cardiomyopathy, or ATTR-CM. New cardiac magnetic resonance imaging data from the Phase 3 ATTRibute-CM study and its open-label extension suggested that some acoramidis-treated patients experienced improvements in cardiac structure and function. A separate post-hoc analysis found that treatment preserved more time alive and time outside the hospital. The findings could help distinguish Attruby, the U.S. brand name for acoramidis, in an increasingly competitive ATTR-CM market. However, “disease reversal” is a stronger claim than these exploratory analyses can establish on their own. Bull Case In the completer analysis, 54% of acoramidis-treated patients achieved a clinically meaningful improvement from baseline in left ventricular systolic function at Month 30, compared with 20% of placebo-treated patients. Among patients receiving continuous acoramidis, 53% showed improvement at Month 42. A separate, more conservative analysis produced the same directional signal. Improvement occurred in 34% of acoramidis-treated patients and 9% of placebo-treated patients at Month 30, while 30% of continuous-acoramidis patients improved at Month 42. In addition, 46% of continuous-acoramidis patients showed improvement in left ventricular mass index at Month 42. The clinical-outcome analysis also pointed in the same direction. Acoramidis reduced the estimated mean percentage of days lost to death or cardiovascular hospitalization to 7.5% from 11.7% with placebo through Month 30. That translated into 38 additional days alive outside the hospital. By Month 36, the observed difference reached 65 days between patients continuously treated with acoramidis and patients initially randomized to placebo who subsequently received acoramidis in the open-label extension. The consistency across imaging, hospitalization, and long-term follow-up strengthens the differentiation hypothesis for BridgeBio Pharma, Inc.. BridgeBio Pharma, Inc. has also begun ASCEND-ATTR, a Phase 3b/4 study designed to prospectively evaluate sustained improvement in cardiac structure, function, and amyloid burden. Bear Case The largest improvement rates came from a completer analysis. Patients who remained in the study and had evaluable follow-up scans may differ from patients who discontinued or lacked repeat imaging, creating potential selection bias. The lower 30% to 34% improvement rates in the conservative analysis are therefore a better measure of how cautiously investors should interpret the signal. The imaging results also came from a substudy, while the Month 42 data were collected during an open-label extension. The comparison with an independent natural-history cohort was not randomized, and the analysis of days alive outside the hospital was post-hoc. These limitations do not invalidate the findings, but they prevent the data from proving disease reversal. BridgeBio Pharma, Inc. also provided no head-to-head comparison with competing ATTR-CM therapies. The analyses therefore cannot establish superior clinical efficacy or justify cross-trial comparisons. Hedge Fund Sentiment The filings available so far reflect positions held before BridgeBio Pharma, Inc. reported the long-term acoramidis analyses. Insider Monkey’s database showed 68 hedge funds holding BridgeBio Pharma, Inc. at the end of 2Q2026, up from 63 funds three months earlier. Conclusion BridgeBio Pharma, Inc. produced several directionally consistent signals across cardiac imaging and hospitalization outcomes. Investors can reasonably give the results weight as evidence of possible differentiation, particularly because a prospective follow-up study is underway. Until ASCEND-ATTR prospectively replicates sustained structural and functional improvement in a predefined analysis, claims that acoramidis reverses ATTR-CM should remain provisional. READ NEXT: Main Street Capital’s (MAIN) Blowout Exit Fuels A Bigger Dividend and Here is Why Chevron (CVX) is a Favorite Among Hedge Funds This article is originally published at Insider Monkey.