BridgeBio Pharma, Inc. (BBIO) recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.The candidate has been approved under the brand name Attruby.BBIO stock surged 16.1% on the FDA approval of the drug.BridgeBio’s shares have lost 32.6% in the year-to-date period against the industry's growth of 10.9%.Image Source: Zacks ...

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- 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 demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date: - In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalizations (CVH)) durably separated ...

- 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) - Data also presented at European Society of Paediatric Endocrinology on November 18th at 10 am GMT - To date, infigratinib has received Breakthrough Designation from the U.S. Food and Drug Administration for achondroplasia, as well as Orphan Drug Designation, Fast ...

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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. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16.50%. A quarter ago, it was expected that this rare disease drug developer would post a loss of $1.09 per share when it actually produced a loss of $1.02, delivering a surprise of 6.42%.Over the last four quarters, the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | --- | --- | --- | |---------------------------|-----------|-------------------------------------------------------| | | | | | | Trading | | | Title of each class | Symbol(s) | Name of each exchange on which registered | 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, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Exhibit 99.1 BridgeBio Pharma Reports Third Quarter 2024 Financial Results and Business Update - Patients on acoramidis, a near complete (≥90%) TTR stabilizer in clinical development, lived longer and better as shown in the ATTRibute-CM study. This is the only Phase 3 study of an ATTR-CM disease-modifying treatment to demonstrate improvement in hard clinical outcomes in the combined assessment of CVH and ACM to this degree, this quickly - BridgeBio's late-stage pipeline continues to rapidly progress with th ...

- Case study co-authored by members of BridgeBio senior management and BridgeBio co-founder and MIT professor, Andrew W. Lo, Ph.D. - Case study features BridgeBio’s unique model that uses portfolio theory to enable early-stage research for genetic diseases and conditions that are not typically addressed by the pharmaceutical industry PALO ALTO, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on ge ...

Upcoming Food and Drug Administration decisions could push these stocks through the roof.Investors looking for stocks that could make dramatic movements in a short, defined time frame want to turn their attention toward the biopharmaceutical industry.There are less than three months left before the end of 2024, but that's plenty of time to see dramatic stock price activity from BridgeBio Pharma (BBIO 2.19%), PTC Therapeutics (PTCT -2.91%), and Vertex Pharmaceuticals (VRTX -1.86%).The U.S. Food and Drug Admi ...