Core Insights - The FDA has accepted BridgeBio Pharma's New Drug Application (NDA) for acoramidis, with an action date set for November 29, 2024, and no advisory committee meeting planned [1] - The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application for acoramidis, with plans for additional global regulatory submissions [1][3] - In the ATTRibute-CM study, acoramidis showed an 81% absolute survival rate and a mean annual cardiovascular-related hospitalization frequency of 0.29, indicating significant clinical benefits [1][2] Regulatory Developments - The FDA's acceptance of the NDA reinforces the potential of acoramidis to contribute significantly to the treatment of patients with ATTR-CM [2] - The company is preparing for further regulatory submissions in other countries and regions following the EMA's acceptance [3] Clinical Study Results - The ATTRibute-CM study reported a Win Ratio of 1.8 (p<0.0001) on the primary endpoint, indicating highly statistically significant results [2] - Acoramidis was well-tolerated with no safety concerns identified during the clinical trials [2] Company Overview - BridgeBio Pharma is a commercial-stage biopharmaceutical company focused on developing transformative medicines for genetic diseases and cancers [4] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient access to new treatments [4]

Core Insights - BridgeBio Pharma, Inc. announced positive results from a Phase 3 trial of acoramidis for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in Japan, showing consistency with global trial results [1][2] - The treatment demonstrated no mortality over a 30-month period and was well-tolerated with no safety concerns identified [1][2] - The findings support local regulatory submission in Japan, with plans for data presentation at a medical meeting [2] Group 1 - The Phase 3 trial was an open-label, single-arm study conducted by Alexion, AstraZeneca Rare Disease, showing a Win Ratio of 1.8 and a highly statistically significant p-value of p<0.0001 in the global ATTRibute-CM trial [1] - At 30 months, an 81% survival rate and a 0.29 annualized cardiovascular hospitalization rate were observed in patients treated with acoramidis [1] - The trial also measured improvements in functional capacity and quality of life, assessed through the six-minute walk test and the Kansas City Cardiomyopathy Questionnaire Overall Summary Score [1] Group 2 - Acoramidis is an investigational oral small molecule designed to stabilize transthyretin (TTR) and is exclusively licensed to Alexion, AstraZeneca Rare Disease for development in Japan [2] - The company aims to leverage advances in genetic medicine to deliver transformative treatments for genetic diseases and cancers [3] - BridgeBio was founded in 2015 and focuses on a pipeline that spans from early science to advanced clinical trials [3]

- 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 facilities of up to $300 million of credit to support strategic pipeline expansio ...

uchar/iStock via Getty Images BridgeBio Pharma, Inc. (NASDAQ:BBIO) is expected to release results from its phase 1/2 study, using BBP-631 for the treatment of patients with congenital adrenal hyperplasia [CAH], in the early part of 2024. This is another catalyst for investors to look forward to, besides the potential for FDA approval of another drug known as Acromidis for the treatment of patients with transthyretin amyloidosis cardiomyopathy, also known as ATTR-CM. A New Drug Application [NDA] submissi ...

Core Insights - BridgeBio Pharma announced positive results from its Phase 3 ATTRibute-CM study of acoramidis for patients with ATTR-CM, demonstrating significant treatment effects on all-cause mortality and cardiovascular-related hospitalization with a Win Ratio of 1.8 (p<0.0001) [1][2] - Acoramidis showed an observed 30-month survival rate of 80.7% in the treatment arm, compared to 74.3% in the placebo arm, and 70.5% in the combined tafamidis treatment arms of ATTR-ACT [2] - The company has submitted a New Drug Application (NDA) to the U.S. FDA and plans to submit additional marketing authorization applications in 2024 [1][3] Efficacy and Safety - Acoramidis was well-tolerated with no safety signals of potential clinical concern identified [1][2] - The study demonstrated statistically significant treatment benefits in various parameters, including 6-minute walk distance and serum TTR levels [2] - The annualized cardiovascular-related hospitalization rate in the treatment arm was 0.29, comparable to the overall hospitalization rate of 0.26 in the U.S. Medicare population [1][2] Regulatory and Market Potential - The NDA submission to the FDA marks a significant step towards making acoramidis available to patients, with additional regulatory submissions planned for 2024 [3] - The results from the ATTRibute-CM study support the hypothesis that greater stabilization of transthyretin (TTR) is associated with improved clinical outcomes [2][3] - BridgeBio's commitment to advancing genetic medicine is reflected in its pipeline, which includes various development programs from early science to advanced clinical trials [4]

PALO ALTO, Calif., Jan. 10, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on January 08, 2024, the compensation committee of BridgeBio's board of directors granted twenty five new employees restricted stock units for an aggregate of 66,963 shares of the Company's common stock. One-fourth of the shares underlying each employee's restricted stock units will ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38959 BridgeBio Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1850815 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38959 BridgeBio Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1850815 (State or other jurisdic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38959 BridgeBio Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1850815 (State or other jurisdi ...

PROPEL2 topline results Forward-looking statements This presentation contains forward-looking statements. Statements in this presentation may include statements that are not historical facts and are considered forward- looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of theSecurities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “exp ...