BridgeBio Pharma, Inc.

BridgeBio Reports Third Quarter 2026 Financial Results and Corporate Updates

BridgeBio reported Q3 2026 total revenues of $353.2 million, up from $120.7 million a year ago, led by $253.2 million of U.S. Attruby net product revenue that grew about $145 million year over year. Loss from operations narrowed to $11.6 million from $145.2 million, helped by a one-time $75.0 million Bayer BEYONTTRA sales milestone, and cash and marketable securities rose to $1.5 billion, which the company says fully funds all three planned launches. Three PDUFA dates fall in the next seven months -- BBP-418 for LGMD2I/R9 (Nov 27, 2026), oral infigratinib for achondroplasia (Feb 4, 2027), and encaleret for ADH1 (May 8, 2027), each with Priority Review -- with field teams hired and launch preparation well advanced. New real-world data showed acoramidis outperforming tafamidis on death, hospitalization, and clinical worsening, supporting continued first-line share gains ahead of new data at AHA 2026.

•3d ago

Encaleret Increased Bone Turnover and Improved Participant-Reported Symptoms in the Phase 3 CALIBRATE Trial in ADH1

BridgeBio presented Phase 3 CALIBRATE data showing encaleret restored endogenous PTH secretion in 91% of ADH1 participants and increased bone turnover markers versus standard of care. Patient-reported outcomes strongly favored encaleret: 100% of treated participants reported improvement in at least one ADH1 symptom versus 46% on standard of care, with gains in fatigue, muscle cramps, brain fog and daily functioning. The FDA has accepted the encaleret NDA in ADH1 with Priority Review and a PDUFA date of May 8, 2027, and an MAA has been submitted to the EMA. BridgeBio also dosed the first participant in RECLAIM-HP, a registrational Phase 3 of encaleret in roughly 160 adults and adolescents with chronic hypoparathyroidism.

•21d ago

BridgeBio to Present New Acoramidis Data, Including Independent Comparative Real-World EHR Data at the HFSA Annual Scientific Meeting 2026

BridgeBio will present ten acoramidis data sets, including an independent real-world comparative effectiveness study versus tafamidis using Epic COSMOS data, at the HFSA Annual Scientific Meeting on October 9-12, 2026. Acoramidis is marketed as Attruby in the U.S. and approved across major global regulators with labels specifying near-complete (≥90%) TTR stabilization. The real-world head-to-head data versus tafamidis could reinforce acoramidis positioning as first-line therapy for ATTR-CM, supporting commercial uptake; no new results are disclosed in this notice.

•26d ago

BridgeBio to Present Additional Evidence from the Phase 3 CALIBRATE Trial of Encaleret in ADH1 at the ASBMR 2026 Annual Meeting

BridgeBio will present additional Phase 3 CALIBRATE data on encaleret in autosomal dominant hypocalcemia type 1 at the ASBMR 2026 Annual Meeting in Boston, October 9-12. Presentations cover encaleret's effects on patient-reported outcomes and bone turnover at 24 weeks, plus a cascade genetic testing program run with the HypoPARAthyroidism Association. A poster will also show no peripheral FGFR1 inhibition at clinically relevant infigratinib exposures, supporting the safety profile in children with achondroplasia in the PROPEL program.

•26d ago

BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia

BridgeBio announced the FDA accepted its NDA for oral infigratinib in children with achondroplasia with Priority Review and a PDUFA target action date of February 4, 2027. The filing rests on the Phase 3 PROPEL 3 trial, which met its primary endpoint with a +2.10 cm/year annualized height velocity treatment difference (p<0.0001) and showed the first statistically significant improvements in body proportionality and arm span in an achondroplasia Phase 3 study. If approved, infigratinib would be the first and only oral therapy for achondroplasia, holding Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease designations; BridgeBio is prepared to launch in the U.S. upon approval and plans an EMA MAA submission in Q4 2026.

•26d ago

BBP-418 Demonstrates Potential to Be Disease Modifying Therapy, Restoring Cardiac and Disease Markers to Unaffected Levels

BridgeBio presented new exploratory cardiac data from the Phase 3 FORTIFY trial of BBP-418 in LGMD2I/R9, showing 100% of treated patients with elevated HS troponin I returned to normal range by Month 12 versus 40% on placebo (p=0.0248). Additionally, 54% of BBP-418-treated participants had stable or improved LVEF versus 25% on placebo (p=0.0262), and glycosylated αDG rose to levels seen in asymptomatic FKRP carriers — a pattern the company says supports disease-modifying potential. BBP-418 is under FDA Priority Review with a PDUFA date of November 27, 2026, and BridgeBio notes the FORTIFY interim met all primary and secondary endpoints; the company may qualify for a Priority Review Voucher upon approval.

•27d ago

Acoramidis Demonstrates Real-World Benefit Versus Tafamidis in ATTR-CM, Reducing Risk of Clinical Worsening

BridgeBio announced peer-reviewed real-world claims data showing acoramidis was associated with a 34% reduction in a composite of clinical worsening events versus tafamidis in ATTR-CM (HR 0.66; p=0.046). Acoramidis also showed a 43% reduction in diuretic intensification risk (HR 0.57; p=0.021), an early marker of worsening heart failure, with benefit separation emerging within weeks of treatment initiation. The retrospective study covered 170 acoramidis and 448 tafamidis patients with a mean follow-up of ~4.6 months, and findings may support frontline treatment selection and switching to Attruby; an independent EHR-based comparative study is expected at an upcoming 2026 medical meeting.

•1mo ago

Oral Infigratinib Shows Meaningful Benefits Beyond Growth Within 52 Weeks in Children with Achondroplasia in the Phase 3 PROPEL 3 Trial

BridgeBio presented new exploratory analyses from the Phase 3 PROPEL 3 trial of oral infigratinib in children with achondroplasia. The data show favorable trends in sleep apnea measures and a 38% reduction in ear infection rates compared to placebo. The company submitted an NDA to the FDA and anticipates a U.S. launch in mid-2027.

•1mo ago

BridgeBio Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans

BridgeBio entered a voluntary agreement with the U.S. government to expand state Medicaid access to its medicines and lower costs for American patients without incurring future pricing mandates. The agreement leverages the GENEROUS Model to expand access to Attruby, while maintaining the ForgingBridges program which can reduce patient out-of-pocket costs to $0 per month. CEO Neil Kumar highlighted that the deal secures the company's ability to innovate for rare genetic diseases, noting that Attruby is currently the lowest-priced product in its class with the best data at 30 months.

•2mo ago

BridgeBio Announces First Participant Dosed in ASCEND-ATTR, a Phase 3b/4 Study Evaluating the Long-Term Effects of Acoramidis on Disease Regression in ATTR-CM

BridgeBio dosed the first participant in the ASCEND-ATTR Phase 3b/4 study evaluating whether long-term treatment with acoramidis (Attruby) can reverse disease progression in ATTR-CM patients. The study aims to confirm previous substudy data suggesting the drug enables cardiac remodeling and amyloid regression rather than just slowing decline. Approximately 150 participants will be followed for 36 months using imaging modalities to assess structural and functional recovery.

•2mo ago

BridgeBio to Present New Acoramidis Data from Open-Label Extension Analyses in ATTR-CM at ESC Congress 2026

BridgeBio announced five presentations at the ESC Congress 2026 detailing new acoramidis data from open-label extension analyses, highlighting durable survival benefits and preserved time alive outside the hospital for ATTR-CM patients. The data further supports acoramidis (marketed as Attruby/BEYONTTRA) as a first-line treatment choice, showing near-complete TTR stabilization and long-term improvements in myocardial structure and quality of life. Separately, three posters presented in partnership with Yale's CarDS Lab will showcase AI-driven tools for earlier ATTR-CM detection and digital monitoring.

•2mo ago

BridgeBio Reports Second Quarter 2026 Financial Results and Corporate Updates

BridgeBio reported Q2 revenue of $243.7 million, up 120% year-over-year, driven by $222.4 million in U.S. Attruby net product revenue and continued uptake in treatment-naïve patients. The company achieved regulatory milestones for its three key assets, with BBP-418 and encaleret receiving Priority Review and PDUFA dates of November 27, 2026, and May 8, 2027, respectively, while oral infigratinib was submitted for achondroplasia. BridgeBio closed a $1 billion preferred equity financing in July, bolstering a balance sheet that held $720.2 million in cash as of June 30, 2026, to support the upcoming launches.

•2mo ago

BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1

BridgeBio announced that the FDA has accepted for filing the New Drug Application (NDA) for encaleret for the treatment of autosomal dominant hypocalcemia type 1 (ADH1), assigning a PDUFA target action date of May 8, 2027. The company noted that the FDA is not currently planning an advisory committee meeting to discuss the application, which supports a streamlined review process for the drug described as a potential blockbuster opportunity. BridgeBio is currently enrolling a pediatric Phase 2/3 trial for encaleret and plans to initiate a Phase 3 study in chronic hypoparathyroidism later this summer, with a European Marketing Authorization Application expected in the second half of 2026.

•3mo ago

Acoramidis Associated with First-Ever Early and Sustained Direct Kidney-Protective Effects in ATTR-CM

BridgeBio announced the publication of post-hoc analyses in Circulation: Heart Failure showing that acoramidis (Attruby) provides direct kidney-protective effects in ATTR-CM patients. The data revealed a 15.5% reduction in UACR by Day 28 and a sustained improved chronic eGFR slope through Month 30, alongside a 58% lower risk of death or cardiovascular hospitalization in the first year. These findings suggest a mechanism similar to SGLT2 inhibitors, potentially differentiating acoramidis from other approved ATTR-CM therapies which have not demonstrated such direct renal effects.

•4mo ago

BridgeBio Raises $1 Billion in Preferred Equity to Accelerate Present and Upcoming Launches

BridgeBio secured up to $1 billion in convertible preferred equity financing led by Sixth Street and HealthCare Royalty, with $933.9 million funded at close. The Series A preferred stock carries a 7% dividend and an initial conversion price of $137.79 per share, representing a premium of over 100% to the company's 30-day VWAP. Management plans to use the proceeds to strengthen the balance sheet and accelerate the launch of Attruby and three other potential blockbuster products expected over the next 12 months.

•4mo ago

BridgeBio Announces Publication in the New England Journal of Medicine of Phase 3 PROPEL 3 Trial of Oral Infigratinib in Children Living with Achondroplasia

BridgeBio published pivotal Phase 3 PROPEL 3 data for oral infigratinib in achondroplasia in the New England Journal of Medicine, marking the first such publication for an achondroplasia trial. The study met its primary endpoint with a least-squares mean treatment difference of +1.74 cm/yr in annualized height velocity versus placebo, and an observed mean difference of +2.10 cm/yr, the largest reported in any Phase 3 achondroplasia study. Infigratinib also demonstrated statistically significant improvements in height Z-score (+0.41 SD), arm span Z-score (+0.37 SD), and body proportionality (-0.05 LS mean difference in children <8 years), with no serious adverse events or discontinuations related to the study drug. BridgeBio plans to submit an NDA to the FDA in Q3 2026 and an MAA to the EMA in H2 2026, with a U.S. launch anticipated in early to mid 2027.

•4mo ago

BridgeBio to Present Primary Results from Phase 3 PROPEL 3 Trial of Oral Infigratinib for Children Living with Achondroplasia at ICCBH 2026

BridgeBio announced that it will present primary results from the Phase 3 PROPEL 3 trial of oral infigratinib for children with achondroplasia at the ICCBH 2026 conference. The company described the data to be shared as positive, marking a significant milestone for the global pivotal study. The late-breaking oral presentation is scheduled for June 28, led by Global Lead Investigator Dr. Ravi Savarirayan.

•4mo ago

BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9

The FDA has accepted BridgeBio's New Drug Application for BBP-418 to treat LGMD2I/R9, granting it Priority Review with a PDUFA target date of November 27, 2026. BBP-418 is poised to be the first and only approved therapy for this specific form of limb-girdle muscular dystrophy, addressing a significant unmet need in a patient population of approximately 7,000 in the U.S. and Europe. The FDA indicated it will not hold an advisory committee meeting, reducing near-term regulatory uncertainty. BridgeBio plans to launch immediately upon approval and is pursuing expedited regulatory pathways in Europe.

•5mo ago

BridgeBio Reports First Quarter 2026 Financial Results and Corporate Updates

BridgeBio reported Q1 total revenue of $194.5 million, up 67% year-over-year, driven by $180.6 million in U.S. Attruby net product revenue. The company submitted an NDA for BBP-418 for LGMD2I/R9, with plans to submit NDAs for encaleret in 1H 2026 and oral infigratinib in Q3 2026. The Board authorized a $500 million share repurchase program as the company holds $940.2 million in cash and equivalents.

•5mo ago

BEYONTTRA™ (acoramidis), the First Near-Complete TTR Stabilizer (≥90%), Approved by ANVISA to Treat ATTR-CM in Brazil

BridgeBio received marketing authorization from Brazil's ANVISA for acoramidis, branded as BEYONTTRA, to treat wild-type or variant transthyretin amyloidosis cardiomyopathy (ATTR-CM). The approval is based on the Phase 3 ATTRibute-CM study, which demonstrated a 42% reduction in the composite of all-cause mortality and recurrent cardiovascular hospitalization compared to placebo at 30 months. The company will partner with Biopas to commercialize the treatment in Brazil, with launch efforts expected to begin in the second half of 2026.

•5mo ago

BridgeBio to Present New Acoramidis Data on Disease Progression, Biomarkers, and Clinical Outcomes at ESC-Heart Failure 2026

BridgeBio and its partner Bayer announced upcoming presentations of new data from the Phase 3 ATTRibute-CM study of acoramidis at the ESC-HF 2026 conference in Barcelona. The featured data includes a late-breaking oral presentation on the drug's impact on outpatient worsening heart failure, alongside additional analyses of biomarkers, hospitalization risk, and patient-reported health status. Acoramidis is currently approved as Attruby in the U.S. and BeyontTRA in Europe and Japan for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).

•5mo ago