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| - | $120.7 million in total third quarter revenue, comprised of $108.1 million of U.S. Attruby® net product revenue, $4.3 million from royalty revenue, and $8.3 million in license and services revenue | ||
| - | As of October 25, 2025, 5,259 unique patient prescriptions have been written by 1,355 unique prescribers, representing an accelerating launch driven by strong month over month growth in the crucial treatment naïve patient segment | ||
| - | Attruby continues to differentiate clinically by proving its unique profile in new subpopulations and holistic analyses: | ||
| - | JACC publication demonstrated the effect of Attruby on cumulative cardiovascular outcomes within the first month of treatment | ||
| - | Positive topline interim analysis results from FORTIFY, the registrational Phase 3 study of BBP-418, a small molecule in development for LGMD2I/R9 | ||
| - | Primary interim analysis endpoint, glycosylated αDG, significantly increased by 1.8x change from baseline at 3 months (p | ||
| - | Average reduction in serum CK, a marker of muscle damage, of 82% change from baseline and statistically significant difference versus placebo (p | ||
| - | Company intends to file an NDA for approval with the FDA in first half of 2026 | ||
| - | Positive topline results from CALIBRATE, the registrational Phase 3 study of encaleret for ADH1 | ||
| - | The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p | ||
| - | In a key secondary analysis, 91% of participants administered encaleret achieved intact PTH above the lower limit of the reference range at Week 24 compared to 7% of participants when on conventional therapy at Week 4 (p | ||
| - | Company intends to submit an NDA to the FDA in first half of 2026 to support a full approval | ||
| - | PROPEL 3, the registrational Phase 3 study of infigratinib for children with achondroplasia expects topline results in early 2026. Infigratinib has previously demonstrated best-in-class improvements in annualized height velocity and upper-to-lower body proportionality and was granted Breakthrough Therapy Designation by the FDA | ||
| - | BridgeBio continues to grow potential impact of its medicines, with plans to share data from the Phase 3 portion of the ACCEL 2/3 study in hypochondroplasia in 2026, initiate clinical trials of encaleret in pediatric ADH1 and chronic hypoparathyroidism in 2026, and begin trials of BBP-418 in pediatric LGMD2I/R9 and in LGMD2M/2U in the near term | ||
| - | The Company ended the quarter with $645.9 million in cash, cash equivalents and marketable securities, well capitalized to commercialize Attruby and advance its late-stage pipeline | ||
| - | Earnings call followed by Q&A with investors and analysts today, October 29th at 4:30 pm ET | ||
BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced its financial results for the third quarter ended September 30, 2025, and provided business updates.
Commercial Progress:
As of October 25, 2025, 5,259 unique patient prescriptions have been written by 1,355 unique prescribers since FDA approval in November 2024. The third quarter revenue totaled $120.7 million, comprised of $108.1 million of U.S. Attruby net product revenue, $4.3 million from royalty revenue, and $8.3 million in license and services revenue.
"Attruby's first year on the market has been remarkable, with continued growth across all market segments and strong physician adoption that reflects both the differentiated clinical profile and the trust we're earning within the community. We're seeing meaningful momentum where prescribers are not only initiating more patients on therapy but continuing treatment, underscoring Attruby's real-world impact," said Matt Outten, Chief Commercial Officer of BridgeBio. "Importantly, this launch has also given us an invaluable blueprint for how we bring best-in-class medicines to patients with genetic diseases. With the promising results seen in BBP-418 for LGMD2I/R9 and encaleret for ADH1, we are building on a proven commercial foundation to ensure these communities, each living with urgent, unmet needs, have timely access to transformative therapies and we will apply the playbook we've developed to prepare for our next potential approvals."
Pipeline Overview:
| Program | Status | Next expected milestone |
| Acoramidis for ATTR-CM | Approved in U.S., EU, Japan, and UK | New variant data to be shared at AHA Scientific Sessions |
| BBP-418 for LGMD2I/R9 | FORTIFY, Phase 3 study interim analysis topline results released | File NDA with FDA in 1H 2026 |
| Encaleret for ADH1 | CALIBRATE, Phase 3 study topline results released | File NDA with FDA in 1H 2026 |
| Infigratinib for achondroplasia | PROPEL 3, Phase 3 study enrollment completed | Topline results in early 2026 |
| Encaleret for chronic hypoparathyroidism | Phase 2 proof-of-principle study completed | Phase 3 study to be initiated in 2026 |
| Infigratinib for hypochondroplasia | ACCEL 2/3, Phase 2 study first participant dosed | Enrollment completion for Phase 2 portion by end of 2025 |
Key Program Updates:
"Attruby's strong commercial performance continues to validate our model, delivering a potential best-in-class medicine to patients who were historically overlooked and building meaningful momentum across all market segments," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "We are now seeing that same success echoed in our pipeline with home-run data in both ADH1 and LGMD2I/R9, and we continue to advance one of the broadest and fastest-moving portfolios in genetic medicine. With achondroplasia data expected in 2026, enrollment nearing completion for the Phase 2 potion of the hypochondroplasia study, and registrational studies for encaleret in chronic hypoparathyroidism and pediatric ADH1 planned next year, we are not slowing down and continue to be impatient for patients. These milestones reflect our growing scalability and strengthen our conviction that BridgeBio is only beginning to show what's possible as we evolve into a durable, multi-medicine company built for patients with genetic diseases for decades to come."
Attruby (acoramidis) – First near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):
- At this year's Heart Failure Society of America (HFSA) Annual Scientific Meeting, BridgeBio presented data from the ATTRibute-CM study showing that acoramidis reduced cumulative cardiovascular outcomes, including cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH), within the first month of treatment in patients with ATTR-CM. At Month 30, Acoramidis significantly reduced the cumulative risk of CVM or recurrent CVH versus placebo with a 49% hazard reduction (p Journal of the American College of Cardiology (JACC) .
- Earlier in the year at the European Society of Cardiology Congress, BridgeBio shared a post-hoc analysis of ATTRibute-CM, demonstrating a significant reduction in risk of CVM through 42 months post-randomization, with a 44% hazard reduction, setting a new standard for CVM outcomes for patients with ATTR-CM. Acoramidis also demonstrated a significant 46% hazard reduction in the risk of the composite outcome of CVM or first CVH through 42 months.
- More data on Attruby will be shared at the American Heart Association (AHA) Congress in November 2025 and in medical congresses throughout 2026.
BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- FORTIFY, the Phase 3 clinical trial of BBP-418, successfully achieved all primary and secondary endpoints of its interim analysis.
- Findings included a highly statistically significant increase of 1.8x change from baseline (p
- An average reduction in serum creatine kinase (CK), a marker of muscle breakdown, of 82% change from baseline (p
- Importantly, statistically significant and clinically meaningful improvements in ambulation