Articles from BridgeBio Pharma, Inc.

- Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types

PALO ALTO, Calif., Jan. 08, 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 co-founder and CEO, Neil Kumar, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT.

PALO ALTO, Calif., Dec. 13, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for acoramidis for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. In the Phase 3 study ATTRibute-CM, acoramidis showed clear benefits on cardiovascular outcomes.

- 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 thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes

- 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 Mortality (ACM) alone at Month 36 within the Open Label Extension

- 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 baseline of +2.50cm/year at Month 18 (P=0.001)

- 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 disease-modifying treatment to demonstrate improvement in hard clinical outcomes in the combined assessment of CVH and ACM to this degree, this quickly 

- Case study co-authored by members of BridgeBio senior management and BridgeBio co-founder and MIT professor, Andrew W. Lo, Ph.D.

- 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 disease course observed in BridgeBio’s ongoing CANinform natural history comparator study

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, announced today that outcomes data through 42 months from the ongoing long-term open-label extension of ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be shared in a featured science oral presentation at the American Heart Association (AHA) Scientific Sessions, taking place in Chicago, Illinois on November 16 – 18, 2024. In addition to the presentation, BridgeBio was selected to share three posters in moderated poster sessions on ATTR-CM.

- Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025

- 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

- Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s)

- Increase in endogenous cortisol production achieved in all patients in higher dose cohorts of BBP-631, a result seen for the first time ever in CAH patients

- Receipt of RMAT Designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which showed functional improvements in all dosed patients indicating that BBP-812 has potential to address the unmet needs of individuals with Canavan disease

PALO ALTO, Calif., Sept. 06, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that on September 4, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 123 new employees in restricted stock units for an aggregate of 359,926 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- In participants who switched from tafamidis and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum transthyretin (TTR) at Month 1 of the OLE (n=21) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18)

PALO ALTO, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced today that additional data on clinical outcomes from ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be presented at the European Society of Cardiology (ESC) Congress 2024, taking place in London, United Kingdom on August 30 – September 2, 2024 and the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024, taking place in Atlanta, Georgia on September 27 - 30, 2024.

PALO ALTO, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that members of the management team will participate in the following upcoming investor conferences:

- The TRACE-AI Network Study will deploy a scalable screening toolkit for ATTR-CM across large, diverse health system electronic health records (EHRs) aiming to identify individuals who have ATTR-CM earlier in their disease course and quantify the potential prevalence of undiagnosed ATTR-CM

PALO ALTO, Calif., Aug. 19, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, and QED Therapeutics, the BridgeBio affiliate focused on developing treatment options for skeletal dysplasias, today announced the launch of the initial phase of MyAchonJourney, a new online resource to support individuals and families living with achondroplasia.

PALO ALTO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that on August 6, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 17 new employees in restricted stock units for an aggregate of 71,859 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases, today reported its financial results for the second quarter ended June 30, 2024, and provided an update on the Company’s operations.

PALO ALTO, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced that Thomas Trimarchi, Ph.D., has been appointed President and Chief Operating Officer (COO) of the company. Dr. Trimarchi will assume his new responsibilities effective immediately and will continue to report directly to CEO and founder, Neil Kumar, Ph.D.

PALO ALTO, Calif., July 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that on July 2, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 25 new employees in restricted stock units for an aggregate of 123,070 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025

PALO ALTO, Calif., June 10, 2024 (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 on June 6, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 18 new employees in restricted stock units for an aggregate of 90,591 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., June 06, 2024 (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 Neil Kumar, Ph.D., founder and CEO of BridgeBio, will present at the Goldman Sachs Annual Global Healthcare Conference in Miami, FL on Wednesday, June 12 at 3:20 pm EDT.

- 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)

PALO ALTO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that members of its management team, along with Ravi Savarirayan, M.D., Ph.D., of Murdoch Children’s Research Institute in Melbourne, Australia, and the global lead investigator for PROPEL 2, will host a call on June 4, 2024, at 8:00 am ET to share results from Month 12 and Month 18 from Cohort 5 of PROPEL 2, a Phase 2 trial of the investigational oral therapy infigratinib in children with achondroplasia.

- 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

- 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 15, 2024 (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 on May 9, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 24 new employees in restricted stock units for an aggregate of 97,557 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., May 14, 2024 (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 members of its management team will present at the Bank of America Merrill Lynch Global Healthcare Conference 2024 in Las Vegas, NV on Wednesday, May 15 at 3:00 pm PT.

- In a pre-specified Cochran-Mantel-Haenszel sensitivity analysis applied to the entire intention-to-treat (ITT) population of the study (N=632), acoramidis significantly reduced all-cause mortality (p=0.04), with no safety signals of potential clinical concern

- Presented cardiac magnetic resonance (CMR) imaging evidence consistent with clinical improvement observed in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the ATTRibute-CM Phase 3 study of acoramidis at the American College of Cardiology Annual Scientific Sessions; additional detailed results from ATTRibute-CM are planned for presentation at 2024 medical meetings, including four abstracts accepted for the European Society of Cardiology Heart Failure conference and eleven abstracts accepted for the International Symposium on Amyloidosis in May 2024

PALO ALTO, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, has announced the completion of a $200M private financing of its former subsidiary, TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT), to accelerate the development of its oncology portfolio. The oversubscribed financing was led by Cormorant Asset Management and co-led by Omega Funds with participation from affiliates of Deerfield Management, GV (Google Ventures), EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital (a Citadel company), Aisling Capital, Casdin Capital, and Longwood Fund.

PALO ALTO, Calif., April 10, 2024 (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 on April 5, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 19 new employees in restricted stock units for an aggregate of 93,088 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on May 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression

PALO ALTO, Calif., March 20, 2024 (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 on March 16, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 16 new employees in restricted stock units for an aggregate of 71,146 shares of the Company’s common stock, with the effective date of March 18, 2024. One-fourth of the shares underlying each employee’s restricted stock units will vest on February 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced the pricing on March 5, 2024 of an underwritten public offering of 8,620,690 shares of its common stock at a public offering price of $29.00 per share, before deducting underwriting discounts and commissions. In addition, BridgeBio has granted the underwriters a 30-day option to purchase up to an additional 1,293,103 shares of its common stock on the same terms and conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $250.0 million, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares in the offering to be sold by BridgeBio.

PALO ALTO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has commenced an underwritten public offering of $250 million of shares of its common stock. BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

- BridgeBio grants Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe

- Submitted New Drug Application (NDA) to US Food and Drug Administration (FDA) for acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) based on positive results of Phase 3 ATTRibute-CM trial, which were published in the New England Journal of Medicine; NDA has been accepted for review with a PDUFA date of November 29, 2024; Marketing Authorization Application (MAA) for acoramidis has also been accepted by the European Medicines Agency (EMA)

- BridgeBio grants Kyowa Kirin exclusive license to develop and commercialize infigratinib for skeletal dysplasias in Japan

PALO ALTO, Calif., Feb. 06, 2024 (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 on February 05, 2024, the compensation committee of BridgeBio’s board of directors granted thirty-five new employees restricted stock units for an aggregate of 123,838 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on February 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application

- Phase 3 open-label, single-arm study conducted in Japan by BridgeBio licensing partner Alexion, AstraZeneca Rare Disease showed consistency with global ATTRibute-CM Phase III trial

- The raise includes $500 million in cash from Blue Owl and CPP Investments in exchange for a 5% royalty on future global net sales of acoramidis

- ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM) and frequency of cardiovascular-related hospitalization (CVH)), with a Win Ratio of 1.8 (p<0.0001)

PALO ALTO, Calif., Jan. 10, 2024 (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 on January 08, 2024, the compensation committee of BridgeBio’s board of directors granted twenty five new employees restricted stock units for an aggregate of 66,963 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on February 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., Jan. 03, 2024 (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 members of its management team will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 8 at 8:15 am PT.

PALO ALTO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, has announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BBO-8520, a first-in-class orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C (ON) state. BBO-8520 binds covalently to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C, leading to rapid and robust inhibition of KRASG12C activity.

- BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia

PALO ALTO, Calif., Dec. 08, 2023 (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 on December 05, 2023, the compensation committee of BridgeBio’s board of directors granted thirty new employees restricted stock units for an aggregate of 147,373 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- NDA submission is based on positive results from ATTRibute-CM Phase 3 study, including a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001), on the primary endpoint (a hierarchical analysis prioritizing in order all-cause mortality (ACM), then frequency of cardiovascular-related hospitalization (CVH), then change from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP), then change from baseline in 6-minute walk distance (6MWD))

- 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)

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 investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin.

PALO ALTO, Calif., Nov. 08, 2023 (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 on November 07, 2023, the compensation committee of BridgeBio’s board of directors granted thirty-three new employees restricted stock units for an aggregate of 183,533 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- Presented detailed positive results from the ATTRibute-CM Phase 3 study of acoramidis at the European Society of Cardiology (ESC) Congress, demonstrating that patients survived more and were hospitalized less than has been seen in other interventional studies of transthyretin amyloid cardiomyopathy (ATTR-CM) to the Company’s knowledge, including real-world evidence presented at recent cardiology medical meetings

PALO ALTO, Calif., Oct. 11, 2023 (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 on October 06, 2023, the compensation committee of BridgeBio’s board of directors granted nineteen new employees restricted stock units for an aggregate of 227,507 shares of the Company’s common stock. With respect to 120,975 shares of restricted stock units, one-fourth of the shares underlying the restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying restricted stock units vesting on a quarterly basis thereafter. With respect to 106,532 shares of restricted stock units, one-eighth of the shares underlying the restricted stock units will vest on February 16, 2024, with one-fourteenth of the remaining shares underlying the restricted stock units vesting on a quarterly basis thereafter. In each case, the vesting is subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- In our study, encaleret restored physiologic mineral homeostasis in 13 participants with ADH1, specifically correcting hypocalcemia and reducing hypercalciuria

- Early assessment of increased glycosylated ⍺DG levels at 3 months predicted subsequent ambulatory improvements at 9 months, supporting the use of glycosylated ⍺DG levels as a potential surrogate endpoint in LGDM2I/R9

PALO ALTO, Calif. and SAN DIEGO, Oct. 03, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, today announced a strategic collaboration to manufacture and advance BBP-812, an investigational adeno-associated virus (AAV) 9 gene therapy for Canavan disease, and BBP-631, an investigational AAV 5 gene therapy for congenital adrenal hyperplasia (CAH).

- $250 million financing led by Qatar Investment Authority (QIA) with significant participation from four of the largest investment management firms in the US

PALO ALTO, Calif., Sept. 08, 2023 (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 on September 06, 2023, the compensation committee of BridgeBio’s board of directors granted twenty-four new employees restricted stock units for an aggregate of 154,186 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

PALO ALTO, Calif., Sept. 07, 2023 (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 members of its management team will present at the Morgan Stanley 21st Annual Global Healthcare Conference in New York, NY on Tuesday, September 12 at 10:50 am ET.

- BridgeBio completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and a scientific advice engagement with the European Union (EU) European Medicines Agency (EMA)

- 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

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).

PALO ALTO, Calif., Aug. 04, 2023 (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 on August 02, 2023, the compensation committee of BridgeBio’s board of directors granted seven new employees restricted stock units for an aggregate of 26,657 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the “Plan”).

- Announced consistently positive results from the Phase 3 ATTRibute-CM study of acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), including a highly statistically significant result observed on the primary endpoint with a Win Ratio of 1.8 (p<0.0001) and clinically meaningful and consistent separation observed on measures of mortality, morbidity, function, and quality of life; the Company intends to file a New Drug Application (NDA) for acoramidis with the U.S. Food and Drug Administration (FDA) by the end of 2023

- BridgeBio met with the U.S. Food and Drug Administration (FDA) to discuss the use of glycosylated αDG levels as a surrogate endpoint; based on this meeting, the Company believes there is potential to pursue Accelerated Approval in the U.S. for BBP-418

PALO ALTO, Calif., July 18, 2023 (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 on July 10, 2023, the compensation committee of BridgeBio’s board of directors granted eight new employees restricted stock units for an aggregate of 71,250 shares of the Company’s common stock. One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

-   Highly statistically significant result observed on primary endpoint with a Win Ratio of 1.8 (p<0.0001)