Aankondiging • Aug 31

Bridgebio Pharma Presents New Analyses from Phase 3 Attribute-Cm Study of Attruby (Acoramidis) in Transthyretin Amyloid Cardiomyopathy

BridgeBio Pharma presented new analyses from the Phase 3 ATTRibute-CM study of Attruby (acoramidis) in transthyretin amyloid cardiomyopathy (ATTR-CM), including the cardiac magnetic resonance imaging (CMR) substudy and the open-label extension (OLE) at the European Society of Cardiology Congress 2026. Acoramidis is the only selective small molecule, orally administered, near-complete (=90%) transthyretin (TTR) stabilizer. The CMR substudy of ATTRibute-CM and its open-label extension provide the first evidence from serial CMR that a therapy can potentially reverse disease progression through Month 42. In a completer analysis, clinically meaningful improvement from baseline in left ventricular (LV) systolic function was observed in 54% of acoramidis-treated patients versus 20% of placebo-treated patients at Month 30, and in 53% of continuous-acoramidis patients at Month 42. Only 26% of completers in an independent natural history cohort demonstrated improved LV systolic function by Month 24 – approximately half the rate observed with acoramidis, suggesting that this magnitude of improvement falls outside the expected natural course of disease. In a conservative analysis, long-term acoramidis treatment was associated with clinically meaningful improvement from baseline in LV systolic function in approximately one-third of patients over 30-42 months. Improvement was observed in 34% of acoramidis-treated patients versus 9% of placebo-treated patients at Month 30 and in 30% of continuous-acoramidis patients at Month 42. In addition, 46% of patients receiving continuous acoramidis demonstrated improvement from baseline in LV mass index at Month 42, providing evidence of favorable structural remodeling. These results provided sufficient evidence for BridgeBio to recently dose its first participant in ASCEND-ATTR, a Phase 3b/4 study designed to determine if acoramidis is associated with sustained improvement in myocardial structural disease progression, function and amyloid burden. In a post-hoc analysis of ATTRibute-CM, acoramidis preserved significantly more time alive outside the hospital for patients with ATTR-CM. The analysis evaluated days lost to death and/or cardiovascular-related hospitalization (DLDCVH), a patient-centered measure that integrates all-cause mortality, cardiovascular-related hospitalizations, and length of stay into a single assessment of disease burden. In participants with ATTR-CM, acoramidis reduced the estimated mean percentage of DLDCVH to 7.5% versus 11.7% with placebo through Month 30. Acoramidis preserved more than one month of additional time alive and out of the hospital (38 days) over 30 months with the benefit nearly doubling to 65 days (observed) over three years, and nearly tripling to up to 94 days (modelled estimates) over three years, reflecting progressive divergence in outcomes over time. Findings in the ATTRibute-CM OLE showed continued benefit of acoramidis in 56 variant ATTR-CM (ATTRv-CM) patients, including 35 p.Val142Ile and 21 non-p.Val142Ile patients through Month 54, demonstrating all-cause mortality (ACM) and cardiovascular mortality (CVM) were markedly lower in the continuous acoramidis arm versus placebo-to-acoramidis across both p.Val142Ile and non-p.Val142Ile variant subgroups. Through Month 54, ACM was 30.4% with continuous acoramidis versus 66.7% with placebo-to-acoramidis in the p.Val142Ile subgroup, and 24.3% with continuous acoramidis versus 57.9% with placebo-to-acoramidis across the overall ATTRv-CM population, a consistent, more than two-fold difference in mortality favoring continuous treatment. The ACM and CVM rates at Month 54 were notably high (~65%) in the p.Val142Ile group who were randomized to placebo in ATTRibute-CM, underscoring the substantial unmet medical need in this high-risk subgroup. Continuous acoramidis achieved sustained increases in serum TTR (sTTR) and persistent attenuation of N-terminal pro-B-type natriuretic peptide (NT-proBNP) rise through Month 54 in both participants with p.Val142Ile or non-p.Val142Ile variants. These Month 54 findings extend the survival benefit and favorable biomarker trends previously reported at Month 30, demonstrating the long-term durability of efficacy and safety of acoramidis in ATTRv-CM, including in the p.Val142Ile subgroup. Acoramidis remained well tolerated through Month 54, with no new safety signals observed in the OLE. Acoramidis improves health-related quality of life in wild-type and variant transthyretin amyloid cardiomyopathy: An EQ-5D-5L subgroup analysis from ATTRibute-CM. Treatment with acoramidis resulted in significant and clinically meaningful benefits in health-related quality of life (HRQoL) in both wild-type ATTR-CM (ATTRwt-CM) and ATTRv-CM. Greater impact on HRQoL versus placebo was observed in participants with ATTRv-CM. Improvement of health status with acoramidis in patients with wild-type and variant transthyretin amyloid cardiomyopathy: KCCQ domains analysis from the ATTRibute-CM Study. In ATTRibute-CM, acoramidis attenuated the decline in heart failure-related health status versus placebo in participants with ATTRwt-CM and ATTRv-CM, with consistent benefits observed across Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) and individual domain scores. A numerical improvement was observed across almost all KCCQ domains in acoramidis-treated participants with ATTRwt-CM and ATTRv-CM relative to placebo. Acoramidis is approved as Attruby by the U.S. FDA and is approved as BEYONTTRA by the European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR. Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

Biotechs Groei van de industrie	-14.59%
Inkomstengroei	52.64%
Rendement op eigen vermogen	n/a
Nettomarge	-97.03%
Laatste winstupdate	30 Jun 2026

Datum	Inkomsten	Inkomsten	G+A Uitgaven	R&D-uitgaven
30 Jun 26	713	-692	646	505
31 Mar 26	580	-722	589	467
31 Dec 25	502	-725	531	452
30 Sep 25	354	-797	451	466
30 Jun 25	236	-776	399	473
31 Mar 25	127	-668	329	477
31 Dec 24	222	-536	289	506
30 Sep 24	218	-439	242	506
30 Jun 24	219	-454	209	511
31 Mar 24	219	-538	185	504
31 Dec 23	9	-643	151	456
30 Sep 23	9	-613	135	416
30 Jun 23	6	-573	130	384
31 Mar 23	78	-425	131	385
31 Dec 22	78	-481	143	399
30 Sep 22	89	-491	166	431
30 Jun 22	91	-509	181	443
31 Mar 22	71	-596	191	436
31 Dec 21	70	-563	189	451
30 Sep 21	57	-535	172	419
30 Jun 21	63	-495	162	407
31 Mar 21	9	-520	154	391
31 Dec 20	8	-449	146	337
30 Sep 20	22	-402	143	304
30 Jun 20	41	-346	131	268
31 Mar 20	41	-291	110	233
31 Dec 19	41	-261	94	210
30 Sep 19	27	-226	74	204
30 Jun 19	0	-197	61	180
31 Mar 19	0	-155	54	151
31 Dec 18	0	-131	44	140

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/09/22 20:18
Aandelenkoers aan het einde van de dag	2026/09/22 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Eliana Merle	Barclays
"Eliana Merle	Barclays
Jason Zemansky	BofA Global Research

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