- 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 welltolerated and demonstrated potentially best-in-class efficacy in PROPEL 2, a Phase 2 study in children with achondroplasia - PROPEL 3, a ...

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 ...

Financial Performance - For the six months ended June 30, 2023, the company incurred a net loss of $303.4 million, compared to a net loss of $203.9 million for the same period in 2022, reflecting an increase of approximately 49%[211] - Revenue for the three months ended June 30, 2023, was $1.6 million, a decrease of $72.1 million from $73.7 million in the same period of 2022[219] - The company incurred a net loss of $303.4 million for the six months ended June 30, 2023, with an accumulated deficit of $2.2 billion[239] - Other income (expense), net for the three months ended June 30, 2023, was $1.5 million, a significant improvement from a loss of $10.8 million in 2022[234] Cash and Securities - As of June 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $333.3 million, down from $428.3 million as of December 31, 2022[218] - As of June 30, 2023, the company held cash, cash equivalents, marketable securities, and restricted cash totaling $353.2 million[261] - The company expects its cash and cash equivalents, marketable securities, and restricted cash to fund operations for at least the next 12 months based on current financial forecasts[242] Research and Development - Research and development expenses for the six months ended June 30, 2023, were $200.3 million, down from $216.0 million in the same period of 2022, a reduction of approximately 7.3%[221] - For the three months ended June 30, 2023, research and development expenses totaled $107.5 million, a slight decrease from $108.4 million in the same period of 2022[226] - The company has created 15 Investigational New Drug applications (INDs) since its inception and has two products approved by the U.S. Food and Drug Administration[211] - The company has over 15 ongoing clinical trials at various stages of development, targeting market opportunities of at least $1.0 billion in annual sales for several programs[211] Restructuring and Charges - Restructuring, impairment, and related charges for the six months ended June 30, 2023, amounted to $6.9 million, compared to $31.1 million for the same period in 2022[214] - The company expects to incur total restructuring charges in the range of approximately $7.0 million to $9.0 million for the fiscal year ending December 31, 2023[214] - Restructuring, impairment, and related charges for the three months ended June 30, 2023, were $3.5 million, down from $8.4 million in the same period of 2022[229] Financing Activities - The company completed a Follow-on public offering on March 10, 2023, issuing 8,823,530 shares at $17.00 per share, resulting in net proceeds of $143.0 million after deducting underwriters' discounts and commissions[244] - The company has filed a shelf registration statement for the registration of common stock and other securities, allowing for future capital raising of up to $450.0 million[244] - The total aggregate principal amount of the term loan is $450.0 million after amendments, with a fixed interest rate of 9.0% per annum[248] - The company issued 2027 Notes in March 2020, totaling $550.0 million, with an interest rate of 2.50% per year, maturing on March 15, 2027[246] - As of June 30, 2023, the company has borrowings under the 2029 Notes totaling $747.5 million, with an interest rate of 2.25% per year, maturing on February 1, 2029[245] Operational Insights - The company does not anticipate generating any revenues from product sales for the remainder of the fiscal year ending December 31, 2023, as selling activities for approved products have been transitioned to partners[211] - The company is closely monitoring macroeconomic events, including inflationary pressures and the COVID-19 pandemic, which may negatively impact financial results[243] - Inflation has increased during the reporting period and may adversely affect the company's operating results in the near future[263] - The company may require additional funding sooner than anticipated due to changes in operating plans or financial forecasts[242] Investment and Securities - The company’s investment in equity securities increased to $50.5 million as of June 30, 2023, compared to $43.7 million as of December 31, 2022[218] - The company is exposed to changes in the fair value of its investment in equity securities, which had a balance of $50.5 million as of June 30, 2023[262] Expenses - Selling, general and administrative expenses for the six months ended June 30, 2023, decreased by $12.9 million to $67.2 million compared to $80.1 million in 2022, primarily due to cost streamlining[226] - Net cash used in operating activities was $257.7 million for the six months ended June 30, 2023, compared to $191.1 million for the same period in 2022, reflecting a change of $66.6 million[253] - Net cash provided by investing activities was $16.4 million for the six months ended June 30, 2023, a significant decrease from $288.3 million in the same period of 2022[254] - Net cash provided by financing activities was $149.0 million for the six months ended June 30, 2023, primarily from the issuance of common stock[255]

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 ...