BBIO - Earnings announcements

$194.5 million in total first quarter revenues, comprised of $180.6 million of U.S. Attruby® net product revenue, with strong prescribing growth and patient persistence driving continued commercial momentumContinued broad uptake among all patient types and HCP segments with particularly strong and growing demand in treatment naïve patients; global launch gaining traction with recent Brazil approvalReal-world evidence reinforces the differentiation demonstrated in trial data. Analysis recently released on medRxiv.org shows Attruby reduces diuretic intensification by 43% compared to tafamidis; in addition, an independent real world evidence study presented at SCAI also revealed statistically s

PALO ALTO, Calif., April 30, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it will release its first quarter 2026 financial results and business update after the market closes on Thursday, May 7, 2026. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at investor.bridgebio.com/events-and-presentations/. A replay of t

$154.2 million in total fourth quarter revenues, net, and $502.1 million in full year revenues, net, primarily comprised of net product revenue of $146.0 million and $362.4 million, respectivelyBridgeBio reported three positive Phase 3 trial readouts in just over three months, a demonstration of its unique model for sustainable drug development as described in a recent peer-reviewed manuscriptAttruby continues to demonstrate clinical differentiation as a first-choice therapy in ATTR-CM with the greatest TTR stabilization on the market (≥90%) and the most rapid benefit on clinical outcomes observed within 1 month, with 7,804 unique patient prescriptions written by 1,856 unique prescribers as

PALO ALTO, Calif., Feb. 17, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced that it will release its fourth quarter and full year 2025 financial results and business updates after the market closes on Tuesday, February 24, 2026. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at investor.bridgebio.com/events-and-presentat

- PROPEL 3 successfully met the primary endpoint of change from baseline in AHV at Week 52 (p<0.0001) - Change from baseline in AHV was superior to placebo at Week 52 with a mean treatment difference against placebo of +2.10 cm/year; the LS mean was +1.74 cm/year - In a pre-specified exploratory analysis of the key secondary endpoint, oral infigratinib achieved the first statistically significant improvement in body proportionality against placebo in achondroplasia, demonstrating an LS mean treatment difference of -0.05 (p<0.05) against placebo in children younger than 8 years old (>50% of the participants) - PROPEL 3 successfully met the key secondary endpoint of change from baseline in

-$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 toplin

- The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints  - 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<0.0001) - 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<0.0001) - Encaleret was well-tolerated with no discontinuations related to study drug - NDA submission planned in th

PALO ALTO, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced plans to release topline results of the autosomal dominant hypocalcemia type 1 (ADH1) CALIBRATE Phase 3 trial before the market opens on Wednesday, October 28, 2025. Members of management will host a conference call to discuss the data at 8:00 a.m. ET the same day. To access the live webcast for BridgeBio's calls, please visit the "Events and Presentations" page within the Investors section of the BridgeBio website at https://investor.bridgebio.com. A replay of the webcasts will be ava

PALO ALTO, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that it will release its second quarter financial results and business updates after the market closes on Tuesday, August 5, 2025. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at investor.bridgebio.com/events-and-presentations/. A replay of the webcast will b

PALO ALTO, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that it will release its first quarter financial results and program updates after the market closes on Tuesday, April 29, 2025. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, please visit the "Events" page within the Investors section of the BridgeBio website at https://investor.bridgebio.com/news-and-events/event-calendar. A replay of the webcast will be a

PALO ALTO, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that it will report financial results for the fourth quarter and full year ended December 31, 2024, on February 20, 2025. As part of the announcement, the Company will also share updates on Attruby's commercialization progress and its late-stage clinical pipeline. The Company will begin hosting earnings calls with the Q1 earnings release, expected in late April or early May, as outlined in its JPM presentation. About BridgeBio Pharma, Inc.BridgeBio Pharma, Inc. (BridgeBio) is a new ty

- In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) - At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at Month 18, as compared to 2.02 at baseline - Infigratinib continues to be well-tolerated as a single daily oral therapy with no adverse events (AEs) assessed as treatment-related in any participant in Cohort 5 - PROPEL 3, the global Phase 3 registrational s

- Acoramidis treatment resulted in increased serum transthyretin (TTR) levels by Day 28 that were sustained and were correlated with a reduced risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH) in ATTR-CM participants through month 30 - Acoramidis treatment resulted in a significant improvement in the composite endpoint of CVM and CVH in ATTR-CM participants, with benefit evident as early as Month 3 - In ATTRibute-CM, participants with at least one CVH had a significantly higher risk of mortality, highlighting the need for ATTR-CM treatments that reduce risk of CVH - BridgeBio also shared the rationale and design of ACT-EAR

- BridgeBio to host investor call on Wednesday, May 29, 2024 at 5:30 pm ET, with presentations from Mathew Maurer, M.D. of Columbia University Irving Medical Center, U.S. and Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S. PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that 12 oral and moderated poster presentations will be shared at the 2024 International Symposium on Amyloidosis (ISA), taking place in Rochester, Minnesota on May 26 - 30, 2024. BridgeBio will also host an investor call on May 2

- As previously announced, the primary endpoint (a hierarchical analysis inclusive of all-cause mortality and frequency of cardiovascular-related hospitalization) was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001) - The placebo and acoramidis time-to-first event Kaplan-Meier (K-M) curves for a composite of all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH) separated beginning at Month 3, representing the most rapid & sustained clinical benefit on the composite endpoint of ACM and CVH in ATTR-CM patients through Month 30 (Hazard Ratio = 0.645) to the Company's knowledge - Acoramidis was well-tolerated, with no safety signals of

PALO ALTO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that additional Phase 3 data on clinical outcomes from ATTRibute-CM, its study of acoramidis in ATTR-CM will be presented at the AHA Scientific Sessions 2023, taking place in Philadelphia, Pennsylvania on November 11 - 13, 2023. As previously announced, a highly statistically significant result was observed on the primary endpoint of ATTRibute-CM with a Win Ratio of 1.8 (p<0.0001). ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigatio

- The primary endpoint was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001); this primary endpoint result consistently favored acoramidis treatment across key subgroups, including across both variant and wild-type ATTR patients as well as across New York Heart Association (NYHA) Class I, II, and III patients. In particular, in contrast to results observed in prior studies of TTR stabilizers, consistency against cardiovascular-related hospitalizations (CVH) was observed across all prespecified subgroups at 30 months - Absolute values observed across all-cause mortality (ACM), cardiovascular mortality (CVM) and CVH showed that over 30 months, patients survived

PALO ALTO, Calif., Aug. 24, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that detailed Phase 3 results from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM, will be presented at the European Society of Cardiology (ESC) Congress 2023, taking place in Amsterdam, Netherlands on August 25 - 28, 2023. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). BridgeBio

-   Highly statistically significant result observed on primary endpoint with a Win Ratio of 1.8 (p<0.0001) -   58% of ties in Finkelstein-Schoenfeld (F-S) primary analysis broken by all-cause mortality and frequency of cardiovascular-related hospitalization; statistical significance also achieved on an F-S test with those two parameters alone (p=0.0182) -   Clinically meaningful and consistent separation observed on all measures of mortality, morbidity, function, and quality of life -   On-treatment survival rate of 81% versus placebo survival rate of 74% (absolute risk reduction of 6.43%; relative risk reduction of 25%) -   Highly statistically significant relative risk reduction of 50

- BridgeBio has developed a validated bioassay that directly measures glycosylated ⍺DG, which is central to LGMD2I disease, and enables monitoring of responses to disease-modifying therapies in LGMD2I patients - BridgeBio also shared 15-month results from its ongoing Phase 2 study, which showed a doubling of glycosylated ⍺DG in LGMD2I patients treated with BBP-418 - A sustained decrease of ≥70% in creatine kinase (CK), a marker of muscle breakdown, was observed with BBP-418 treatment at 15 months - Improvements in ambulatory and clinical function measures were observed after 15 months of treatment with BBP-418 - Based on the Phase 2 results, BridgeBio is embarking on a registration-enab

- BridgeBio will also share 15-month Phase 2 data and review the Phase 3 clinical trial design of BBP-418, a potential therapeutic for patients with LGMD2I, with initiation of its Phase 3 study expected in mid-2023 - Preliminary findings and study results will be presented in an oral presentation and posters at the Muscular Dystrophy Association (MDA) 2023 Annual Meeting - Additionally, BridgeBio will host an investor call with Jeffrey Rosenfeld, M.D., Ph.D., a specialist in neuromuscular medicine and professor of neurology at Loma Linda University School of Medicine on Tuesday, March 21 at 8:30 am ET to discuss the findings on the bioassay, the updated Phase 2 study results and the prelim

- In the highest dose level (Cohort 5, 0.25 mg/kg once daily), the mean change from baseline in annualized height velocity (AHV) at six months was +3.03 cm/yr (p = 0.0022) for the first 10 children with at least six months of follow-up in Cohort 5. The two remaining children who have not yet had six months of follow-up have a mean change from baseline in AHV of +8.8 cm/yr based on three months data - 80% of children at six months were responders, as defined by an increase from baseline AHV of at least 25%. The mean change from baseline in AHV of responders was 3.81 cm/yr - As a result of treatment, the median absolute AHV reached 7.6 cm/yr, which is beyond the 99th percentile of growth for

- BridgeBio to host investor call today (October 17, 2022) at 1:30 pm ET to discuss its two most advanced RAS precision oncology programs – KRASG12C GTP/GDP dual inhibitor development candidate BBO-8520, and its novel PI3Kα:RAS breaker mechanism which is in late lead optimization - KRASG12C GTP/GDP dual inhibitor BBO-8520 has shown significantly greater potency in KRAS models than first-generation KRAS G12C GDP-only inhibitors as measured by its ability to bind and covalently modify KRASG12C, block KRASG12C binding to effector proteins such as RAF, and inhibit downstream signaling - BBO-8520 was shown to retain potency in the context of receptor tyrosine kinase drive, which renders

- The conference will take place at the National Cancer Institute at Frederick, Maryland from October 17-19, 2022 - Presentation to include details from next-generation G12C dual inhibitor clinical candidate and characterization of advanced leads from the PI3Kα:RAS breaker program - BridgeBio will host an investor call on October 17, 2022 at 1:30 pm ET to discuss the data and next steps for its two lead RAS programs - RAS is the most common oncogenic driver with approximately 30% of all human cancers being driven by RAS mutations, including large proportions of lung, colorectal and pancreatic tumors. PIK3CA is the second most common oncogene in human tumors, being present in more than 30%

- Treatment with encaleret resulted in rapid and sustained restoration of normal mineral homeostasis, with mean values of blood calcium, urinary calcium, and blood PTH within the normal range by day 5 of therapy and sustained at 24 weeks, and was well-tolerated without any reported serious adverse events - At week 24 of encaleret treatment, 92% (12/13) of participants had achieved normal trough blood calcium levels in the absence of extra-dietary calcium supplements and active vitamin D, and 77% (10/13) of participants had normal urinary calcium excretion - The Company completed its end of Phase 2 interaction with the US FDA; the Phase 3 pivotal study is anticipated to begin in 2022 and w

- BridgeBio will host an investor call on June 13, 2022, at 4:30 pm ET to discuss the Phase 2b study results and the planned pivotal Phase 3 study design PALO ALTO, Calif., June 09, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that 24-week Phase 2b data of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1) will be featured in an oral presentation at the Endocrine Society (ENDO) 2022 Annual Conference, taking place in Atlanta, GA on June 11 – 14, 2022. At ENDO 2022, BridgeBio will also participate in a rapid-fire poste

- 43% increase in the ratio of glycosylated alpha-dystroglycan (αDG) to total αDG from baseline were measured across all three dosing cohorts, signifying the oral therapy has the potential to address both the root cause of LGMD2i and drive functional improvements for patients- Average of 70% reduction in creatine kinase (CK), a key marker of muscle breakdown, after 90 days of treatment and average 77% reduction after 180 days- Increase in velocity in the 10-meter walk test (10MWT) at day 90 and 180, which is an improvement over the decline in velocity seen in the natural history data- If the development program is successful, BridgeBio believes BBP-418 could be the first approved therapy for

PALO ALTO, Calif., March 11, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that it will host an investor call on March 14, 2022, at 8:00 AM ET to discuss data from its Phase 2 study of BBP-418 in patients with limb-girdle muscular dystrophy type 2i (LGMD2i). The results will be featured at the Muscular Dystrophy Association (MDA) 2022 Annual Meeting, taking place in Nashville, Tennessee on March 13 – 16, 2022. With approximately 7,000 patients in the U.S. and European Union with potentially treatable mutations, LGMD2i is an inherited autosom

- ATTRibute-CM did not meet its primary endpoint at Month 12. Mean observed six-minute walk distance (6MWD) decline for the acoramidis and placebo arms were 9 meters and 7 meters, respectively. Both declines are similar to healthy elderly adults and less than prior untreated ATTR-CM cohorts - The company observed improvements at Month 12 on the Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS, nominal p < 0.05), a quality-of-life measurement, N-terminal pro BNP (NT-proBNP, median +0.6% vs. +24.3%, nominal p < 0.05), a cardiac biomarker, and serum TTR concentration (mean +38.5% vs. -0.7%, nominal p < 0.01), a measure of TTR stabilization - Acoramidis was generally

•  Application accepted under Priority Review designation•  Application accepted into Real Time Oncology Review (RTOR) pilot program•  This is BridgeBio’s second NDA acceptance•  Application will also be submitted for review in Australia and Canada under Project Orbis PALO ALTO, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infig