Acoramidis’s hazard ratio of .41 for time to ACM or first CVH versus placebo in the ATTRibute-CM study subgroup of ATTRv-CM patients achieved statistical significance in a pre-specified analysis This profound treatment effect, due to the near-complete stabilization (≥90%) and binding of TTR, represents the greatest observed benefit to date for ATTRv-CM patients, an ATTR-CM population with poor prognosis In the ATTRibute-CM... Read More

In the Japanese Phase 3 study, 0% mortality was reported over the 30-month treatment period and acoramidis was well-tolerated The approval was based on a Japanese Phase 3 study and the global ATTRibute-CM Phase 3 trial, which demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date. Key data from the ATTRibute-CM study include: In as few as 3 months, the time to first event (all-cause mortality (ACM)... Read More

PALO ALTO, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced today that cardiovascular outcomes data in patients with variant and wild-type ATTR-CM from the ATTRibute-CM, its Phase 3 study of acoramidis in ATTR-CM, will be shared in a flatboard poster presentation at the American... Read More

PALO ALTO, Calif., March 21, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that on March 19, 2025, the compensation committee of BridgeBio’s board of directors approved equity grants to 10 new employees in restricted stock units for an aggregate of 30,782 shares of the Company’s common... Read More

PALO ALTO, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, announced that Thomas Trimarchi, Ph.D. has been appointed President and Chief Financial Officer (CFO) of the Company. He recently assumed the role of Principal Financial Officer and will continue to lead the Company’s FP&A and... Read More

Refinancing term debt facility lowers interest expense, eliminates near-term amortization payments, and significantly extends debt maturity Offering priced at 1.75% interest rate and 45% conversion premium PALO ALTO, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc . (Nasdaq: BBIO) (the “Company,” “we” or “BridgeBio”) announced today the pricing of $500 million aggregate principal amount of 1.75% convertible... Read More

Long term debt management strategy will strengthen the balance sheet without increasing total liabilities Refinancing term debt facility lowers interest expense, eliminates near-term amortization payments, and significantly extends debt maturity PALO ALTO, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the “Company,” “we” or “BridgeBio”) announced today that it intends to offer, subject to... Read More

As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval Attruby (acoramidis), the first and only near-complete TTR stabilizer (≥90%) was approved by the FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients on November 22, 2024 Acoramidis was approved as BEYONTTRA™ in the EU on February 10, 2025,... Read More

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... Read More

The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placebo A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month... Read More

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 Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia) Well-financed to launch Attruby and read out major market Phase 3 trials: $406M... Read More

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 43 rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT. To access the live webcast of BridgeBio’s... Read More

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the Phase 3 ATTRibute-CM study; final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission within the coming months Acoramidis, a near-complete (≥90%) stabilizer of transthyretin (TTR), was approved on November 22, 2024, by the... Read More

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 Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date: In as few as 3 months, the time to first event (all-cause... Read More

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 The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of early... Read More

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) Data also presented at European Society of Paediatric Endocrinology on November 18 th at 10 am GMT To date, infigratinib has received Breakthrough Designation from the U.S. Food and... Read More

- 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 BridgeBio’s late-stage pipeline continues to rapidly progress with three Phase 3... Read More

Case study co-authored by members of BridgeBio senior management and BridgeBio co-founder and MIT professor, Andrew W. Lo, Ph.D. Case study features BridgeBio’s unique model that uses portfolio theory to enable early-stage research for genetic diseases and conditions that are not typically addressed by the pharmaceutical industry PALO ALTO, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO)... Read More

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 Significant and sustained reductions in N-acetylaspartate (NAA) levels in urine, cerebrospinal fluid (CSF), and brain in all participants... Read More

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... Read More

Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025 BridgeBio believes there is an opportunity to pursue Accelerated Approval in the U.S. for BBP-418 in LGMD2I/R9 based on a potential biomarker surrogate endpoint of glycosylated alpha-dystroglycan (αDG) at time of the interim analysis If successful, BBP-418 could be the first approved therapy for individuals... Read More

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 Additionally, results from a Phase 3 trial in adults with ATTR-CM conducted in Japan were presented, with no ACM events reported over the 30 month treatment period in participants administered acoramidis Greater transthyretin (TTR) stabilization... Read More

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) BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United... Read More

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 BridgeBio will leverage the benefits of RMAT designation, including early and more frequent interactions with the FDA, to establish an Accelerated... Read More

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 The gene therapy was well tolerated with no treatment-related serious adverse events (SAEs) reported Despite novel scientific advancements achieved with this program, the data do not warrant additional capital investment at this time and the gene therapy budget is being... Read More

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... Read More

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) Increased serum TTR at Day 28 of ATTRibute-CM was correlated with reduced risk of all-cause mortality (ACM), cardiovascular... Read More

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... Read More

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: Morgan Stanley 22 nd Annual Global Health Care Conference , New York, NY: Fireside Conversation on September 4 th at 10:00 am ET... Read More

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. 26, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a... Read More

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... Read More

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... Read More

Acoramidis demonstrated a significant impact on mortality, hospitalizations, and quality of life Starting at Month 3, patients taking acoramidis showed meaningful and sustained improvement in time to first event (CVH or ACM) Acoramidis demonstrated a 42% reduction in composite CVH and ACM events relative to placebo by Month 30 Increased serum TTR levels by Day 28 were correlated with a reduced risk of events (ACM, CVM, and... Read More

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... Read More

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... Read More

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 Recent Type C interactions with U.S. Food and Drug Administration (FDA) focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio's belief that there is... Read More

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... Read More

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. To access the live webcast... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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. To access the live webcast of... Read More

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 Among ATTRibute-CM participants enrolled with Stage 4 chronic kidney disease (CKD) (N=21), acoramidis treatment was associated with proportionally fewer deaths compared... Read More

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... Read More

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 This capital raise provides BBOT with runway to achieve significant clinical inflection points over the next... Read More

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... Read More

In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM These results are the first prospective, longitudinal... Read More

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... Read More

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... Read More

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... Read More

BridgeBio grants Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe BridgeBio to receive royalties according to a tiered structure beginning in the low-thirties percent, designed to provide BridgeBio the opportunity to maximally share in the blockbuster potential of acoramidis BridgeBio will also receive up to $310 Million USD in... Read More

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... Read More

BridgeBio grants Kyowa Kirin exclusive license to develop and commercialize infigratinib for skeletal dysplasias in Japan BridgeBio to receive upfront payment of USD 100 million with royalties up to the high-twenties percent, with additional milestone-based payments Infigratinib is a once daily oral treatment option under development for achondroplasia, which was well-tolerated and demonstrated potentially best-in-class... Read More

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... Read More

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 Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual... Read More

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 No mortality was reported over the 30 month acoramidis treatment period Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified These results support local regulatory submission in Japan The findings from... Read More

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 The raise also includes a $450 million credit facility from Blue Owl that refinances existing senior secured credit, extending maturity from 2026 to 2029 subject to certain conditions Additionally, the agreement with Blue Owl provides for the possibility of additional incremental... Read More

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) Acoramidis demonstrated an observed 30-month survival rate of 80.7% in the treatment arm of ATTRibute-CM; recent data from the U.S. Social Security Administration... Read More

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... Read More

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 42 nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 8 at 8:15 am PT. To access the live webcast of BridgeBio’s... Read More

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 potentially highly potent small molecule direct inhibitor of KRAS G12C that binds to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRAS G12C BBO-8520 is expected to significantly improve outcomes for patients with... Read More

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 The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) shared positive feedback that the PROPEL 3 trial design would be acceptable as a registrational study to support a marketing... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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 The... Read More

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... Read More

In our study, encaleret restored physiologic mineral homeostasis in 13 participants with ADH1, specifically correcting hypocalcemia and reducing hypercalciuria Rapid and sustained impact of encaleret on mineral homeostasis was observed, specifically in the normalization of blood calcium, urine calcium and parathyroid hormone (PTH) No serious adverse events were reported with encaleret and no treatment discontinuations or... Read More

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 Long-term data from the ongoing Phase 2 study of BBP-418 in patients with LGMD2I/R9 at Month 21 demonstrate a well-tolerated safety profile, and stabilization in 10 meter walk test (10MWT), 100-m timed test... Read More

Resilience to manufacture BridgeBio’s lead investigational gene therapy treatments, BBP-631 and BBP-812 Partnership provides an innovative, capital efficient, sustainable model for BridgeBio to develop, test and deliver transformative medicines for patients more quickly PALO ALTO, Calif. & SAN DIEGO / Oct 03, 2023 / Business Wire / BridgeBio Pharma, Inc. (NASDAQ: BBIO) (BridgeBio), a commercial-stage biopharmaceutical... Read More

$250 million financing led by Qatar Investment Authority (QIA) with significant participation from four of the largest investment management firms in the US BridgeBio anticipates this raise, coupled with several less dilutive financings available to the Company, fully capitalizes the Company to profitability PALO ALTO, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the... Read More

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... Read More

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. To access the live webcast of... Read More

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) FDA and EMA alignment was reached on the adequacy of a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial for infigratinib to support a marketing application for the treatment of children with achondroplasia The primary... Read More

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,... Read More

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,... Read More

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.... Read More

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... Read More

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 BridgeBio has dosed the first participant in FORTIFY, its global Phase 3 study of BBP-418 in patients with LGMD2I/R9 FORTIFY includes an interim analysis at 12 months focused... Read More

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.... Read More

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... Read More

PALO ALTO, Calif., July 14, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will host an investor call on Monday, July 17 at 8:00 am ET to share topline results from the Phase 3 ATTRibute-CM clinical study in patients with transthyretin amyloid cardiomyopathy... Read More

Project ‘NADER’ is intended to span multiple phases, starting from mapping rare diseases in the UAE and wider region through innovative risk assessment algorithms, and moving towards clinical trials with transformative medicines ABU DHABI, United Arab Emirates and PALO ALTO, Calif., July 12, 2023 (GLOBE NEWSWIRE) -- Burjeel Holdings, one of the largest healthcare providers in the MENA region, and BridgeBio Pharma, Inc. , a... Read More

Treatment with infigratinib at the Cohort 5 dose level resulted in a significant and robust increase in annual height velocity (AHV), with a mean change of +3.38 cm/year from baseline 83% of children in Cohort 5 responded to infigratinib, as defined by an increase from baseline AHV of at least 25%. The mean change from baseline in AHV of responders was +4.08 cm/year Early but promising trends towards improvement in... Read More

PALO ALTO, Calif., June 13, 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 June 11, 2023, the compensation committee of BridgeBio’s board of directors granted 14 new employees restricted stock units for an aggregate of 76,800 shares of the Company’s common stock.... Read More

PALO ALTO, Calif., June 08, 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 the updated six month results from Cohort 5 in PROPEL2, a Phase 2 trial of the investigational therapy, infigratinib in children with achondroplasia will be featured in an oral presentation at the... Read More

Following treatment, the N-acetylaspartate (NAA) levels of CANaspire participants are consistent with levels seen in individuals with milder Canavan disease based on findings from the Company’s natural history study and reports in the scientific literature Sustained reductions in NAA were measured in the urine, cerebrospinal fluid (CSF), and brain of all participants and have been observed for over a year in the earliest... Read More

PALO ALTO, Calif., May 15, 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 updated data from CAN aspire , its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease,... Read More

PALO ALTO, Calif., May 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 May 9, 2023, the compensation committee of BridgeBio’s board of directors granted 12 new employees restricted stock units for an aggregate of 149,400 shares of the Company’s common stock.... Read More

Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) has now completed last patient last visit and remains on track for topline month 30 registrational data to be announced in late July 2023 Positive results announced in Cohort 5 of Phase 2 PROPEL 2 trial of low-dose infigratinib in children with achondroplasia, demonstrating mean increase in annualized height velocity... Read More

PALO ALTO, Calif., April 27, 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 Bank of America Merrill Lynch Global Healthcare Conference in Las Vegas, NV on Wednesday, May 10 at 10:00 am PT. To access the live webcast of... Read More

PALO ALTO, Calif., April 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 April 7, 2023, the compensation committee of BridgeBio’s board of directors granted 11 new employees restricted stock units for an aggregate of 134,300 shares of the Company’s common stock. All... Read More

PALO ALTO, Calif., April 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 on March 7, 2023, the compensation committee of BridgeBio’s board of directors granted five new employees restricted stock units for an aggregate of 25,900 shares of the Company’s common stock. All... Read More

BBP-398, an investigational SHP2 inhibitor, is a potentially best-in-class therapy for use in combination approaches, which is shown by preclinical findings demonstrating its safety profile, continuous, once-daily dosing regimen and synergistic efficacy to treat cancers driven by KRAS mutations If successful, the combination of investigational therapy BBP-398 and OPDIVO has the potential to address the serious unmet need for... Read More

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... Read More

- 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... Read More

PALO ALTO, Calif., March 08, 2023 (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 7, 2023 of an underwritten public offering of 8,823,530 shares of its common stock at a public offering price of $17.00 per share, before deducting underwriting discounts and commissions. In... Read More

PALO ALTO, Calif., March 06, 2023 (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 $150 million of shares of its common stock. BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of... Read More

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... Read More

PALO ALTO, Calif., March 03, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will host an investor call on Monday, March 6 at 7:30 am ET to discuss Phase 2 Cohort 5 data from its PROPEL2 clinical trial of the investigational therapy infigratinib in children with... Read More

Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) continues to have high operating fidelity; month 30 topline registrational data are expected to be announced in mid-2023 Phase 2 PROPEL 2 trial of low-dose infigratinib as a potential treatment option for children with achondroplasia continues to progress with Cohort 5 data expected to be announced in March of 2023... Read More

PALO ALTO, Calif., Feb. 17, 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 February 13, 2023, the compensation committee of BridgeBio’s board of directors granted 11 new employees restricted stock units for an aggregate of 59,800 shares of the Company’s common stock.... Read More

PALO ALTO, Calif., Feb. 13, 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 host a roundtable discussion on Thursday, February 16 at 12:00 pm ET with Melita Irving, clinical geneticist at Guy's and St Thomas' NHS Foundation Trust, London,... Read More

PALO ALTO, Calif., Feb. 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 members of the management team will participate in the following upcoming investor conferences: SVB Securities Global Biopharma Conference, Virtual: Tuesday, February 14 th at 2:20 pm ET Goldman... Read More

PALO ALTO, Calif., Jan. 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 members of its management team will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 9 at 3:00 pm PT. To access the live webcast of BridgeBio’s... Read More

The CALIBRATE Phase 3 study design incorporates feedback from global regulatory agencies and will compare the effects of encaleret to standard of care on blood and urinary calcium concentrations over a 24 week treatment period in patients with autosomal dominant hypocalcemia type 1 (ADH1) The primary composite endpoint evaluates the proportion of participants with ADH1 achieving blood and urinary calcium within widely... Read More

BridgeBio to host investor call today (October 17, 2022) at 1:30 pm ET to discuss its two most advanced RAS precision oncology programs – KRAS G12C GTP/GDP dual inhibitor development candidate BBO-8520, and its novel PI3Kα:RAS breaker mechanism which is in late lead optimization KRAS G12C GTP/GDP dual inhibitor BBO-8520 has shown significantly greater potency in KRAS models than first-generation KRAS G12C GDP-only inhibitors... Read More

Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG from baseline towards normal levels, suggesting that the investigational oral therapy, BBP-418, has the potential to address the root cause of LGMD2i Large, sustained reduction in creatine kinase (CK) (>75%), a key marker of... Read More

Robust post-dosing changes continue to be seen in key markers associated with severity of disease Pharmacodynamic data from the first three participants show sustained reductions in N-acetylaspartate (NAA) in the brain and urine, suggesting that the investigational therapy is producing functional ASPA enzyme If successful, BridgeBio’s gene therapy could be the first therapeutic option for children born with Canavan disease,... Read More

BBP-398, an investigational SHP2 inhibitor, is a potentially optimal agent for use in combination therapies given its continuous, once-daily dosing in addition to synergistic activity with other agents to treat cancers driven by KRAS G12C mutations The combination of investigational therapy BBP-398 and LUMAKRAS, if successful, has the potential to address the serious unmet need for patients with KRAS G12C-mutated non-small... Read More

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... Read More

The first and only treatment in Europe to treat patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years. European Commission (EC) decision is based on the efficacy and safety data collected to date compared to data from a natural history study. NULIBRY was BridgeBio’s first... Read More

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 the management team will participate in the following upcoming investor conferences: Citi’s 17th Annual BioPharma Conference, Boston, MA: September 7 th at 8:50 am ET Morgan Stanley Global Healthcare Conference, New York, NY: September 13... Read More

Initial data readout for patients with PA and MMA expected in the first half of 2023 Interim data from healthy individuals, reported earlier this year, showed that BBP-671 was detected in plasma and cerebrospinal fluid (CSF) at concentrations above predicted therapeutic thresholds, suggesting the compound has the potential to impact key systemic and neurological complications of PA and MMA BridgeBio is in active discussions... Read More

NULIBRY is the first and only approved therapy in the United States (U.S.) and in Israel to treat patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years NULIBRY received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2022 recommending approval by the European... Read More

Reported positive interim Phase 2 data for infigratinib in achondroplasia demonstrating a mean increase in annualized height velocity (AHV) of 1.52 cm/year among all Cohort 4 children 5 years of age and older, and announced addition of a 5 th cohort to the trial Reported positive Phase 2 data for encaleret in autosomal dominant hypocalcemia type 1 (ADH1) and announced design of the Phase 3 pivotal study, which is expected to... Read More

At the highest dose level evaluated to date (Cohort 4, 0.128 mg/kg once daily), the mean change from baseline in annualized height velocity (AHV) was +1.52 cm/yr (p=0.02, n=11) and the responder rate was 64% in children 5 years and older 1 Infigratinib was well-tolerated with no serious adverse events (SAE) and no discontinuations due to adverse events (AE) including in Cohort 5 (dose: 0.25 mg/kg once daily) participants... Read More

CHMP recommendation for approval of NULIBRY in the European Union (EU) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A is based on the efficacy and safety data collected to date compared to data from a natural history study Under an accelerated assessment pathway, a decision by the European Commission (EC), which authorizes marketing approval in the European Union (EU), is expected on the... Read More

BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a new collaboration with Baylor College of Medicine to identify and translate cutting-edge research into potential therapies for patients with genetic diseases. “In these challenging times we believe it is more important than ever to be a stalwart partner to academic institutions... Read More

BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced its founding affiliation with Bakar Labs, the incubator at UC Berkeley’s Bakar BioEnginuity Hub. Bakar Labs was established by the University of California (UC), Berkeley and QB3, UC’s research institute for innovation and entrepreneurship in the life sciences and is open to academic... Read More

BBP-711 led to near complete inhibition of glycolate oxidase throughout the dosing period and greater than 10-fold increases in plasma glycolate, suggesting it has the potential to be both a best-in-class therapy and the first oral therapy for PH1 and recurrent kidney stone formers Based on the tolerability and potency of the oral therapy, BridgeBio has met with regulators and intends to initiate a Phase 2/3 pivotal study by... Read More

These results are the first reported demonstration of rapid and robust treatment changes in key disease markers associated with the severity of disease Initial pharmacodynamic results for two participants show unprecedented decreases in N-acetylaspartate (NAA) in the brain and urine, suggesting the therapy is producing functional ASPA enzyme If successful, BridgeBio’s gene therapy could be the first therapeutic option for... Read More

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... Read More

BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and its affiliate company Venthera, Inc. (Venthera), today announced preliminary data from the Phase 1b trial of VT30 topical gel (BBP-681) in patients with venous, lymphatic and mixed venolymphatic lesions of the skin (VM, LM and VLM, respectively), which are rare genetic vascular anomalies driven by dysregulated activation of intracellular PI3K. The data are being shared in... Read More

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 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)... Read More

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 the management team will participate in the following upcoming investor conferences: Jefferies Healthcare Conference, New York, NY: Thursday, June 9 th at 4:00 pm ET Goldman Sachs Global Healthcare Conference, Ranchos Palos Verdes, CA:... Read More

BBP-671 detected in healthy volunteer plasma and cerebrospinal fluid (CSF), suggesting that BBP-671 is entering the brain, a location critical to target neurological complications of PKAN and organic acidemias at their source Results showed BBP-671 increased whole blood acetyl-coenzyme-A (CoA) levels, a signal supporting proof of mechanism of the therapy Based on these data, BridgeBio intends to move forward with the second... Read More

PTR-01 was well-tolerated over a four-month treatment period in RDEB patients Treatment with PTR-01 led to rapid, consistent, and durable wound healing as observed in reduction of wound surface area and clinician-reported assessments All patients that completed the study reported a decrease in pain over the course of treatment with PTR-01 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate company Phoenix Tissue Repair,... Read More

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 the management team will participate in the following upcoming investor conferences: Citi Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Panel, Virtual : Wednesday, May 18 th at 2:30 pm ET H. C. Wainwright Global Investment Conference,... Read More

-Entered into a definitive agreement to sell the rare pediatric disease Priority Review Voucher (PRV) it obtained in February 2021 for $110 million -Secured a two-year extension of interest-only period on its existing senior secured credit facility BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has entered into a... Read More

BridgeBio is eligible to receive up to $905 million, including an upfront payment of $90 million, and up to $815 million in additional milestone payments and royalties SHP2 inhibitor deal expands earlier agreement between BridgeBio and Bristol Myers Squibb to study BBP-398 in combination with OPDIVO® (nivolumab) in advanced solid tumors with KRAS mutations BridgeBio will continue to lead its three current Phase 1 monotherapy... Read More

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 participate in the Bank of America Securities Healthcare Conference in Las Vegas, NV on Wednesday, May 11 th at 7:40 pm ET. To access the live webcast of BridgeBio’s presentation, please visit the “Events &... Read More

Completed sale to Sentynl Therapeutics of BridgeBio’s NULIBRY™ (Fosdenopterin) for Injection Updated strategic collaboration with Helsinn Group to develop, manufacture and commercialize infigratinib in oncology indications in the U.S.; BridgeBio is eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn Released positive data from Phase 2 study of... Read More