BBIO

EX-99.1

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EX-99.1

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Exhibit 99.1

BridgeBio Reports Third Quarter 2026

Financial Results and Corporate Updates

- $353.2 million in total third quarter revenues, primarily comprised of $253.2 million of U.S. Attruby net product revenue (up approximately $31 million sequentially and $145 million year over year). Loss from operations was $11.6 million, driven by increased revenue and a one-time $75.0 million BEYONTTRA sales milestone from Bayer. Cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026, fully funding all three launches and expansion indications

- Attruby growth was again led by the treatment-naïve segment, with both the number of newly diagnosed patients starting treatment and Attruby's share of those starts increasing

- Real-world evidence continues to differentiate acoramidis from tafamidis on outcomes that matter to patients, physicians, and payers: (i) an independent Epic COSMOS analysis of 2,684 patients found an 18% lower risk of death, hospitalization, new atrial fibrillation or diuretic escalation (p<0.01) with a 25% lower risk of hospitalization with acoramidis (p<0.001); (ii) the first peer-reviewed real-world comparison of TTR stabilizers found 34% less clinical worsening with acoramidis (p=0.046)

- Cardiac MRI from ATTRibute-CM and its extension showed evidence of potential reversal of structural damage and functional decline through 42 months for patients on acoramidis, with up to half of completers achieving clinically meaningful improvement in heart function. The first participant was dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby

- BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review. Launch preparation is well advanced, with 70% of patients concentrated at MDA Care Centers, over 70% of which the field team has reached with a 90% target by PDUFA. Based on interactions with EU national health authorities, the Company intends to submit an MAA to the EMA in the first half of 2028

- Oral infigratinib for achondroplasia has a February 4, 2027 PDUFA date, with Priority Review. The MAA is now under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with the U.S. field team fully staffed. In hypochondroplasia, the Phase 2/3 ACCEL study is expanding to higher doses to find the optimal dose, supported by safety data from PROPEL 3 and PROPEL OLE

- Encaleret for ADH1 has a May 8, 2027 PDUFA date, with Priority Review, and the MAA is under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with >600 genetically confirmed patients identified, up from approximately 500 last quarter, and the U.S. field team is fully deployed

- The first participant was dosed in RECLAIM-HP, the Phase 3 study for encaleret in chronic hypoparathyroidism. Topline data are expected in early 2028, representing a potential second indication in an estimated population of 200,000 patients in the U.S. and EU

PALO ALTO, Calif., October 29, 2026 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the third quarter ended September 30, 2026, and provided an update on Attruby’s commercial progress.

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Pipeline Overview:

ProgramStatusNext expected milestone

Acoramidis for ATTR-CMApproved in U.S., EU, Japan, Switzerland, Brazil, U.K., and AustraliaNew data to be shared at AHA 2026

BBP-418 for LGMD2I/R9PDUFA date set for November 27, 2026, with Priority ReviewU.S. launch upon FDA approval

Oral infigratinib for achondroplasiaPDUFA date set for February 4, 2027, with Priority Review; MAA submitted to EMAU.S. launch upon FDA approval

Encaleret for ADH1PDUFA date set for May 8, 2027, with Priority Review; MAA submitted to EMAU.S. launch upon FDA approval

Encaleret for chronic hypoparathyroidismFirst participant dosed in RECLAIM-HP, registrational Phase 3 studyTopline data anticipated early 2028

Oral infigratinib for hypochondroplasiaEnrolling additional dose cohorts for Phase 2 studyInitiation of dosing in additional dose cohorts

Depleter (BBP-717) for ATTR-CMDevelopment candidate nominationSubmit IND to the FDA in 2027

“I’m heartened by how consistently the evidence for acoramidis keeps pointing in the same direction,” said Neil Kumar, Chief Executive Officer of BridgeBio. “This quarter we added two more large real-world comparisons to a growing body of data showing acoramidis outperforming tafamidis on the outcomes that matter most to patients: survival and hospitalizations. This is exactly what you would expect from the only near-complete stabilizer on the market, and it is deeply gratifying to see it borne out in the real world. This is also a particularly special moment for the company. Thre

EX-99.1

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Document

Exhibit 99.1

BridgeBio Reports Second Quarter 2026

Financial Results and Corporate Updates

- $243.7 million in total second quarter revenues, primarily comprised of $222.4 million of U.S. Attruby® net product revenue, with growth led by the treatment-naïve segment as physicians increasingly start and keep patients on Attruby

- Attruby is the first ATTR-CM therapy associated with direct kidney protection, with post-hoc analyses published in Circulation: Heart Failure showing a profile consistent with ACE inhibitors, ARBs, and SGLT2s including an early, reversible eGFR dip, an improved chronic eGFR slope relative to placebo, and a 13.7% reduction in urinary albumin-to-creatinine ratio through Month 30; the magnitude of the acute eGFR dip was positively associated with greater early cardiovascular benefit; BridgeBio will explore the potential for Attruby to treat other orphan kidney indications

- Real-world evidence continues to differentiate Attruby from tafamidis, with an independent propensity score-matched analysis of 286 patient pairs from the TriNetX network published in JSCAI associating acoramidis with a 37% reduction in composite cardiovascular events (p=0.002) and a 34% reduction in hospitalizations (p=0.002) at six months; further independent RWE using electronic health records are expected, and we are confident Attruby will consistently demonstrate clinical superiority over tafamidis to the benefit of patients and healthcare delivery systems for which heart failure remains a top concern

- All three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026); encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either; oral infigratinib for achondroplasia has been submitted, with U.S. launch expected mid-2027

- Diagnosis and awareness continue to accelerate ahead of the launches: in ADH, more than 2,200 unique patients are now identified under the dedicated ICD-10 code, at approximately 70 new diagnoses per month; in LGMD2I/R9, BridgeBio is investing in awareness and multidisciplinary care at MDA Care Center Network sites, where we expect 85% of target physicians to be familiar with the BBP-418 profile and data by launch

- The oral encaleret and oral infigratinib franchises continue to expand beyond their first indications: RECLAIM-HP in chronic hypoparathyroidism has begun screening patients with topline data anticipated in late 2027 or early 2028, CALIBRATE-PEDS in pediatric ADH1 has completed enrollment in its first cohort, and a Phase 2 update in hypochondroplasia is expected in the second half of 2026

- $720.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which does not include the $1 billion preferred equity financing that closed on July 1, 2026

- BridgeBio will host a Commercial Day in New York City on October 8, 2026, to discuss commercial readiness and launch strategy across its three upcoming launches

PALO ALTO, Calif., August 10, 2026 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the second quarter ended June 30, 2026, and provided an update on Attruby’s commercial progress.

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Pipeline Overview:

ProgramStatusNext expected milestone

Acoramidis for ATTR-CM Approved in U.S., E.U., Japan, Switzerland, Brazil, and U.K.New data to be shared at ESC 2026

BBP-418 for LGMD2I/R9PDUFA date set for November 27, 2026 with Priority ReviewLaunch upon FDA approval

Encaleret for ADH1PDUFA date set for May 8, 2027 with Priority Review; MAA submitted to EMALaunch upon FDA approval

Oral infigratinib for achondroplasiaNDA submitted to FDAFDA sets PDUFA date

Oral Encaleret for chronic hypoparathyroidismFirst investigational sites activated for RECLAIM-HP, Phase 3 studyFirst participant dosed in Q3 2026

Oral infigratinib for hypochondroplasiaACCEL 2/3 enrollment ongoingPhase 2 clinical trial update in 2H 2026

Depleter for ATTR-CMDevelopment candidate nominationSubmit IND to the FDA in 2027

“I'm excited by the growing body of evidence continuing to demonstrate Attruby is the drug of choice for all ATTR-CM patients, and particularly for those who are treatment-naïve, including the first-ever demonstration of early, sustained kidney-protective effects in ATTR-CM alongside the cardiac benefit we've established. Furthermore, this was the quarter all three of our pipeline programs, BBP-418, encaleret, and infigratinib, moved from data into active regulatory review, with our first PDUFA date now set for November 27, 2026, which is a level of strategic execution and discipline I'm proud of. Finally, with the $1 billion preferred equity financing we completed, we have a balance sheet sized to run all three l

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