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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BridgeBio Pharma, Inc. expects results from the phase 1/2 study, using gene therapy BBP-631 for the treatment of patients with congenital adrenal hyperplasia, in early 2024. The congenital adrenal hyperplasia treatment market is expected to reach $892 million by 2033. Potential FDA acceptance of regulatory application of acromidis for the treatment of patients with ATTR-CM, expected within 60 days after submission achieved December 5th of 2023.

BridgeBio Pharma: FDA Submission Acromidis And Top Line Results On Deck

- 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

BridgeBio Pharma Announces Publication of Positive Results from Phase 3 ATTRibute-CM Study of Acoramidis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in the New England Journal of Medicine

BridgeBio's FDA filing for acoramidis and advances in KRAS mutation cancer treatment contrast with growing financial losses. Acoramidis competes with Pfizer's ATTR-CM treatments; BBIO's oncology focus includes promising KRAS inhibitors and RAS-targeting strategies. Financially, the Company reports increased net loss and share count, yet possesses a solid short-term solvency with high long-term debts.

BridgeBio Pharma's Robust Pipeline Could Benefit From A Partner

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.

BridgeBio Pharma to Participate in the J.P. Morgan Healthcare Conference

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 announces FDA clearance of IND application for BBO-8520, a first-in-class direct inhibitor of KRASG12C (ON)

Cytokinetics

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- 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

BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

- 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

BridgeBio Pharma Announces Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

- 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

BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

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

BridgeBio Pharma to Present Additional Data from the Phase 3 ATTRibute-CM Study in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the American Heart Association (AHA) Scientific Sessions 2023

- 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

BridgeBio Pharma Reports Third Quarter 2023 Financial Results and Business Update

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: Can the Stock Move Higher?

A well-respected financial services company initiated coverage on the biotech. It flagged it with its equivalent of a buy recommendation.

Why BridgeBio Pharma Was a Healthy Stock Today

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”).

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

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

BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

- 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

BridgeBio Pharma Shares Positive Long-Term Data from an Ongoing Phase 2 Study, which Support the Potential Use of Glycosylated Alpha-dystroglycan (⍺DG) Levels as a Surrogate Endpoint in Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)

PALO ALTO, Calif. & SAN DIEGO--(BUSINESS WIRE)-- #biomanufacturing--BridgeBio Pharma, Inc. (NASDAQ: BBIO) (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-6.

BridgeBio and Resilience Announce Strategic Multi-Year Partnership to Advance BBP-631, BBP-812 and Future Gene Therapy Treatments

BridgeBio Pharma's Q2 2023 YoY revenue plummeted, but PIPE financing extends cash runway to 15 months, alleviating short-term liquidity concerns. Acoramidis poses a threat to Pfizer's tafamidis in ATTR-CM space, pending FDA approval; yet high debt and complex capital structure loom large. Investment recommendation: "Buy" for high-risk tolerance investors, hinging on upcoming FDA decision on acoramidis and management of significant debt obligations.

BridgeBio: Bets Acoramidis As The Pfizer Spoiler

BridgeBio Pharma Inc.'s stock BBIO, +1.11% jumped 3.8% in premarket trade Monday, after the company announced a $250 million private investment in public equity, or PIPE, equity offering led by the Qatari sovereign fund. The Palo Alto, Calif.

BridgeBio's stock jumps 3.8% premarket after company announces $250 million PIPE financing led by Qatari sovereign fund

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

BridgeBio Pharma Announces $250 Million Private Placement Equity Financing

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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 Pharma to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

- 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)

BridgeBio Pharma Announces Positive Feedback from the U.S. FDA and EU EMA on the Regulatory Path for a Pivotal Phase 3 Trial of Infigratinib in Children with Achondroplasia

BridgeBio Pharma stands a chance of taking on Pfizer in a heart disease, an analyst said Monday. But BBIO stock reversed its premarket gain.

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