BridgeBio Pharma Inc

BridgeBio Pharma, Inc. engages in identifying and advancing transformative medicines to treat patients who suffer from Mendelian diseases. Its pipeline of development programs includes product candidates ranging from early discovery to late-stage development. The company was founded by Charles Homcy, Frank McCormick, Philip Reilly, and Neil Kumar in 2015 and is headquartered in Palo Alto, CA.

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The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said on Friday, making it the first new treatment in a market dominated by Pfizer's blockbuster Vyndaqel.

US FDA approves BridgeBio's drug for rare heart condition

- 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™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients

On Monday, BridgeBio Pharma, Inc.  BBIO presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association Scientific Sessions.

BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market

- 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

Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 Months

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced the appointment of Praveen Tipirneni, MD, to its Board of Directors as a non-executive director. Dr. Tipirneni most recently served as President and CEO of Morphic Therapeutics Inc. from company founding until the acquisition by Eli Lilly for $3.2 billion, and brings a wealth of i.

BridgeBio Oncology Therapeutics (BBOT) Appoints Praveen Tipirneni, MD, to its Board of Directors as Non-Executive Director

- 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)

BridgeBio Pharma Announces Publication in the New England Journal of Medicine of Phase 2 PROPEL 2 Study of Infigratinib for Children Living with Achondroplasia

BridgeBio Pharma, Inc.'s acoramidis is awaiting FDA's approval decision for transthyretin amyloidosis, with strong clinical data suggesting a likely approval and potential “blockbuster” status. The PDUFA date is 29th Nov. Despite past setbacks, including a Phase 3 failure, recent data shows significant improvements in survival rates and cardiovascular-related hospitalizations, bolstering the approval case. BridgeBio has secured substantial funding and partnerships, indicating confidence in acoramidis' market potential, but commercial success remains uncertain due to competition from Pfizer and Alnylam.

BridgeBio: 2 Weeks Until Major Drug Approval Catalyst - A Buy, With Caveats

BridgeBio Pharma (BBIO) came out with a quarterly loss of $0.86 per share versus the Zacks Consensus Estimate of a loss of $1.03. This compares to loss of $1.08 per share a year ago.

BridgeBio Pharma (BBIO) Reports Q3 Loss, Lags Revenue Estimates

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

BridgeBio Announces Publication of Case Study Exploring Portfolio Theory's Impact on Biomedical Innovation in The Journal of Portfolio Management

BridgeBio Pharma (BBIO) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

BridgeBio Pharma (BBIO) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced that the first patient has been dosed with BBO-10203 in the BREAKER-101 trial. BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors, without directly inhibiting the catalytic.

BridgeBio Oncology Therapeutics (BBOT) Announces First Patient Dosed with First-in-Class BBO-10203, a RAS:PI3Kα Breaker, in the Phase 1 BREAKER-101 Trial for Advanced Solid Tumors

- 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

BridgeBio Shares Positive Data from High Dose Cohort of Phase 1/2 CANaspire Study of Gene Therapy BBP-812 for Canavan Disease at ESGCT 2024

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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.

BridgeBio to Present Outcomes Data Through 42 Months from the Open-Label Extension of ATTRibute-CM, the Phase 3 Study of Acoramidis for Treatment of ATTR-CM, at 2024 AHA Scientific Sessions

On Friday, BridgeBio Pharma, Inc. BBIO presented a post-hoc analysis evaluating the effect of acoramidis on the composite endpoint of all-cause mortality (ACM) and recurrent cardiovascular-related hospitalizations (CVH) events in its Phase 3 ATTRibute-CM study in ATTR-CM.

BridgeBio Pharma's Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease

- 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 living with LGMD2I/R9 in the U.S. - Enrollment completion announced on 10 th annual LGMD Awareness Day, a collaborative yearly effort on September 30 th to globally raise awareness of individuals living with LGMD PALO ALTO, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced, on LGMD Awareness Day, the completion of enrollment of FORTIFY, the Company's Phase 3 registrational study of BBP-418 in individuals with LGMD2I/R9.

BridgeBio Completes Enrollment of FORTIFY, Phase 3 Registrational Study of BBP-418 in Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)

- 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

BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization Events

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- 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 Announces Infigratinib Is the First Ever Investigational Therapeutic Option for Achondroplasia to Be Awarded Breakthrough Therapy Designation by the FDA

BridgeBio Pharma said on Tuesday it will stop development of its experimental therapy for a genetic disease that affects the adrenaline-producing gland.

BridgeBio to stop development of therapy for genetic disorder

- 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

BridgeBio Pharma Reports Topline Results from Phase 1/2 Trial of Investigational Gene Therapy for Congenital Adrenal Hyperplasia (CAH)

- 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 Receives FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation for BBP-812 Canavan Disease Gene Therapy Program

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage precision oncology company, has announced the appointment of Yong (Ben) Ben, MD, as Chief Medical and Development Officer. In this new role, Dr. Ben will oversee BBOT's ongoing clinical programs, driving the development and delivery of new therapies for cancer patients. These include BBO-8520, BBO-10203, and BBO-11818. “Ben is a highly accomplished leader.

BridgeBio Oncology Therapeutics (BBOT) Announces the Appointment of Yong Ben, MD, as Chief Medical and Development Officer

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”).

BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

BridgeBio's stock is underperforming this year despite the progress the company made in recent quarters. HELIOS-B trial of Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, but the data presentation this week should lift this overhang on the stock. Investor focus should turn to the potential FDA approval and launch of acoramidis for the treatment of ATTR CM, followed by three late-stage clinical readouts in 2025.

News for BridgeBio Pharma Inc Stock (BBIO)