BridgeBio(BBIO)
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BridgeBio(BBIO) - 2023 Q4 - Annual Results
2024-02-21 16:00
Exhibit 99.1 BridgeBio Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update - Submitted New Drug Application (NDA) to US Food and Drug Administration (FDA) for acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) based on positive results of Phase 3 ATTRibute-CM trial, which were published in the New England Journal of Medicine; NDA has been accepted for review with a PDUFA date of November 29, 2024; Marketing Authorization Application (MAA) for ac ...
Analysts Estimate BridgeBio Pharma (BBIO) to Report a Decline in Earnings: What to Look Out for
Zacks Investment Research· 2024-02-15 16:06
The market expects BridgeBio Pharma (BBIO) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they ...
BridgeBio Pharma and Kyowa Kirin Announce Partnership with an Upfront Payment of $100 Million for an Exclusive License on Infigratinib in Skeletal Dysplasias in Japan
Newsfilter· 2024-02-07 12:34
- 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 ...
BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Newsfilter· 2024-02-05 12:30
- Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application - Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned - In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual cardiovascular-related hospitalization (CVH) frequency, as well as improvements ...
BridgeBio Pharma Shares Positive Results of Single-Arm Phase 3 Study of Acoramidis in Japanese Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Including No Mortality Reported in the Trial at 30 Months
Newsfilter· 2024-02-02 12:00
- Phase 3 open-label, single-arm study conducted in Japan by BridgeBio licensing partner Alexion, AstraZeneca Rare Disease showed consistency with global ATTRibute-CM Phase III trial - No mortality was reported over the 30 month acoramidis treatment period - Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified - These results support local regulatory submission in Japan - The findings from this study build upon positive results from BridgeBio's global ATTRibute-CM P ...
BridgeBio Pharma Secures up to $1.25 Billion of Capital from Blue Owl and CPP Investments to Accelerate the Development and Launch of Genetic Medicines
Newsfilter· 2024-01-18 12:00
- 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 ...
BridgeBio Pharma: FDA Submission Acromidis And Top Line Results On Deck
Seeking Alpha· 2024-01-11 22:19
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 ...
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
Newsfilter· 2024-01-10 22:15
- 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<0.0001) - Acoramidis demonstrated an observed 30-month survival rate of 80.7% in the treatment arm of ATTRibute-CM; recent data from the U.S. Social Security Administration estimated 30-month survival at 85% in an age-matched cohort of the general population; ...
BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-01-10 12:30
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 ...
BridgeBio(BBIO) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
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 ...