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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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.

Acoramidis Receives Positive CHMP Opinion for Treatment of Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

SANTA CRUZ, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Unnatural Products, Inc. (UNP), a biotech developing orally-delivered macrocyclic peptides to address previously undruggable targets, announced today that BridgeBio Pharma, Inc. (Nasdaq: BBIO), has exercised its option to license macrocyclic peptide candidates discovered using UNP's AI-enabled massively parallel chemistry platform.

Unnatural Products Announces BridgeBio Exercises Option to License Macrocyclic Therapeutics for Development in Rare Diseases and Oncology

BBIO gets a significant boost with the FDA approval of acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy. Stock rises.

BridgeBio Stock Up on FDA Approval of Cardiovascular Drug

BridgeBio Pharma snagged FDA approval for its rival to Pfizer's heart disease treatment, Vyndaqel. BridgeBio stock catapulted.

BridgeBio Catapults After Snagging Approval For Pfizer-Rivaling Heart Drug

Pfizer

On Friday, the FDA approved BridgeBio Pharma, Inc.'s BBIO Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization.

FDA Approves BridgeBio Pharma's Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market

BridgeBio announced the FDA approval of Attruby (acoramidis) for the treatment of patients with ATTR-CM. The label looks clean and it includes all the relevant clinical data. Attruby's approval also triggers a $500 million milestone payment to BridgeBio under the royalty-backed deal it signed earlier this year and removes a regulatory and funding overhang on the stock.

BridgeBio: Next Chapter Begins After Attruby Approval

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

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