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BridgeBio Raises $300 Million Through Partial Capped Monetization of BEYONTTRA® European Royalty
Globenewswire· 2025-06-30 11:30
Core Viewpoint - BridgeBio Pharma has entered into a royalty financing agreement, selling a portion of its royalties from BEYONTTRA sales in Europe for $300 million, which will provide immediate capital to support its operations and product launches [1][2][4]. Financial Details - The agreement allows BridgeBio to receive $300 million in exchange for 60% of royalties on the first $500 million of annual BEYONTTRA net sales in Europe, with total payments capped at 1.45 times the initial investment [3][4]. - BridgeBio has previously received $210 million in upfront and regulatory milestone payments from Bayer for BEYONTTRA and anticipates an additional $75 million in near-term milestone payments [4]. Product Information - BEYONTTRA is an orally administered stabilizer of transthyretin (TTR) for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [6][8]. - Acoramidis, the active ingredient in BEYONTTRA, has shown significant clinical benefits, including a 42% reduction in composite adverse cardiovascular events and a 50% reduction in cumulative frequency of cardiovascular events at 30 months compared to placebo [6]. Strategic Partnerships - The partnership with HealthCare Royalty and Blue Owl Capital is aimed at strengthening BridgeBio's balance sheet to support the launch of Attruby and its pipeline of genetic medicines [2][3]. - HCRx has expressed confidence in the commercial potential of BEYONTTRA and is committed to supporting innovation in the biopharmaceutical industry through this investment [3].
Acoramidis Reduced Incidence of Atrial Fibrillation Events in Patients with ATTR-CM
Globenewswire· 2025-05-20 11:30
Core Insights - Acoramidis has shown significant clinical benefits in reducing the incidence of atrial fibrillation (AF) and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][4][5] - The drug has received regulatory approvals in multiple regions, including the U.S. and Europe, indicating its potential as a treatment option for ATTR-CM [1][6] Group 1: Clinical Outcomes - In a post-hoc analysis of the ATTRibute-CM study, acoramidis reduced the annual frequency of cardiovascular hospitalizations (CVH) due to AF/atrial flutter (AFL) by 43% compared to placebo [1][4] - The incidence of new-onset AF/AFL was reduced by 17% in patients with no prior history of AF when treated with acoramidis [1][4] - A 42% reduction in composite all-cause mortality (ACM) and recurrent CVH events was observed at Month 30 relative to placebo [3] - Acoramidis treatment led to a greater than 50% reduction in ACM and CVH in participants with variant ATTR-CM compared to placebo [7] Group 2: Functional Capacity and Quality of Life - Patients with variant ATTR-CM treated with acoramidis showed a clinically significant slower decline in functional capacity and quality of life compared to placebo [7] - At Month 30, the mean difference in the 6-minute walk distance was 86.7 meters in favor of acoramidis (p = 0.0048) [7] - The KCCQ-OS score change from baseline at Month 30 was 20.3 points higher in the acoramidis group compared to placebo (p = 0.0019) [7] Group 3: Regulatory Approvals and Future Directions - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission and other regulatory agencies [1][6] - The company plans to present more data on the benefits of acoramidis for ATTR-CM patients at future medical meetings [6]
Early and Sustained Increase in Serum TTR Levels by Acoramidis Independently Predicted Improved Survival in the ATTRibute-CM Study
Globenewswire· 2025-05-19 16:33
Core Insights - The study of acoramidis in the ATTRibute-CM trial indicates that early and sustained increases in serum transthyretin (TTR) levels are associated with improved survival outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][2][5] - Acoramidis, a near-complete TTR stabilizer, has shown significant clinical benefits, including reductions in all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH) [1][6][12] Group 1: Clinical Findings - A 5-mg/dL increase in serum TTR level within 28 days of treatment initiation correlates with a relative risk reduction of mortality of up to 31.6% through Month 30 [1][5] - The ATTRibute-CM study is the first to demonstrate a direct link between increased serum TTR and survival in ATTR-CM patients [1][2] - Acoramidis treatment resulted in a mean increase of 9.1 mg/dL in serum TTR levels within 28 days, which was sustained throughout the 30-month treatment period [5][6] Group 2: Statistical Outcomes - The study reported a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 [4] - A 50% reduction in the cumulative frequency of CVH events was observed relative to placebo at Month 30 [4] - The analysis showed that the early increase in serum TTR levels was associated with reduced ACM, independent of baseline risk factors [5][6][12] Group 3: Regulatory Approvals - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and UK Medicines and Healthcare Products Regulatory Agency [1][7] Group 4: Company Overview - BridgeBio Pharma, Inc. focuses on developing transformative medicines for genetic diseases and has a pipeline that includes advanced clinical trials [10]
BridgeBio Reports First Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-04-29 20:01
Core Insights - BridgeBio Pharma reported $36.7 million in net product revenue for Attruby in its first full quarter, with 2,072 unique patient prescriptions written by 756 prescribers as of April 25, 2025 [1][2] - The company has made significant progress in its clinical trials, including the full enrollment of the observational run-in study for hypochondroplasia Phase 2 trial ahead of schedule [1][6] - BridgeBio ended the quarter with $540.6 million in cash and cash equivalents, excluding anticipated regulatory milestone payments of $105 million for ex-U.S. approvals of BEYONTTRA [1][9] Commercial Progress - The first full quarter of Attruby net product revenue was $36.7 million, with 2,072 unique patient prescriptions written by 756 healthcare providers since FDA approval in November 2024 [2][13] - The Chief Commercial Officer highlighted a 42% reduction in all-cause mortality and a 50% decrease in cardiovascular hospitalizations at 30 months for patients treated with Attruby [3] Pipeline Overview - Acoramidis for ATTR-CM is approved in the U.S., EU, Japan, and UK, with the first participant in the ACT-EARLY Phase 3 trial expected to be dosed in 2025 [4] - BBP-418 for LGMD2I/R9 and encaleret for ADH1 have completed enrollment in their Phase 3 studies, with topline results expected in the second half of 2025 [4][6] - Infigratinib for achondroplasia is fully enrolled, with topline results anticipated in early 2026 [4][6] Key Program Updates - Attruby has shown strong clinical efficacy and safety, contributing to its growth in the ATTR-CM treatment paradigm [5][6] - The Phase 2 proof-of-principle study of encaleret in hypoparathyroidism showed 78% of participants achieving normal calcium levels within 5 days, with plans to advance to a registrational study in 2026 [6][7] Financial Updates - Cash and cash equivalents decreased to $540.6 million as of March 31, 2025, primarily due to operating activities and loan repayments [9][10] - Total revenues for the three months ended March 31, 2025, were $116.6 million, down from $211.1 million in the same period the previous year, mainly due to a decrease in license and services revenue [10][11] - The company recorded a net loss attributable to common stockholders of $167.4 million for the quarter, compared to a loss of $35.2 million for the same period in 2024 [20]