Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
13 déc. 2024 07h18 HE
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BridgeBio Pharma, Inc.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the Phase 3 ATTRibute-CM study; final approval decision,...
Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients
22 nov. 2024 19h11 HE
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BridgeBio Pharma, Inc.
- Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of...
Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 Months
18 nov. 2024 11h15 HE
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BridgeBio Pharma, Inc.
- Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause...
BridgeBio Pharma Announces Publication in the New England Journal of Medicine of Phase 2 PROPEL 2 Study of Infigratinib for Children Living with Achondroplasia
18 nov. 2024 05h30 HE
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BridgeBio Pharma, Inc.
- In Cohort 5 of PROPEL 2, daily oral treatment of infigratinib at 0.25mg/kg resulted in statistically significant and sustained increases in annualized height velocity (AHV), with a mean change from...
BridgeBio Pharma Reports Third Quarter 2024 Financial Results and Business Update
12 nov. 2024 07h30 HE
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BridgeBio Pharma, Inc.
- Patients on acoramidis, a near complete (≥90%) TTR stabilizer in clinical development, lived longer and better as shown in the ATTRibute-CM study. This is the only Phase 3 study of an ATTR-CM...
BridgeBio Announces Publication of Case Study Exploring Portfolio Theory’s Impact on Biomedical Innovation in The Journal of Portfolio Management
05 nov. 2024 07h30 HE
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BridgeBio Pharma, Inc.
- Case study co-authored by members of BridgeBio senior management and BridgeBio co-founder and MIT professor, Andrew W. Lo, Ph.D. - Case study features BridgeBio’s unique model that uses portfolio...
BridgeBio Shares Positive Data from High Dose Cohort of Phase 1/2 CANaspire Study of Gene Therapy BBP-812 for Canavan Disease at ESGCT 2024
24 oct. 2024 07h30 HE
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BridgeBio Pharma, Inc.
- Continued, progressive improvement in motor function and achievement of motor milestones at 12-months post-treatment represents an important and statistically significant change, in contrast to the...
BridgeBio to Present Outcomes Data Through 42 Months from the Open-Label Extension of ATTRibute-CM, the Phase 3 Study of Acoramidis for Treatment of ATTR-CM, at 2024 AHA Scientific Sessions
03 oct. 2024 07h30 HE
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BridgeBio Pharma, Inc.
PALO ALTO, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases,...
BridgeBio Completes Enrollment of FORTIFY, Phase 3 Registrational Study of BBP-418 in Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)
30 sept. 2024 07h30 HE
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BridgeBio Pharma, Inc.
- Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025 - BridgeBio believes there is an opportunity to pursue Accelerated Approval in the...
BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization Events
27 sept. 2024 18h00 HE
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BridgeBio Pharma, Inc.
- Acoramidis treatment led to a highly significant reduction in all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) at Month 30 compared with placebo - Additionally,...