The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the Phase 3 ATTRibute-CM study; final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission within the coming monthsAcoramidis, a near-complete (≥90%) stabilizer of transthyretin (TTR), was approved on November 22, 2024, by the U.S. Food and Drug Administration (FDA) as Attruby™ to reduce cardiovascular death an ...

SANTA CRUZ, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Unnatural Products, Inc. (UNP), a biotech developing orally-delivered macrocyclic peptides to address previously undruggable targets, announced today that BridgeBio Pharma, Inc. (Nasdaq: BBIO), has exercised its option to license macrocyclic peptide candidates discovered using UNP’s AI-enabled massively parallel chemistry platform. This milestone signifies a significant milestone in the collaboration between the two companies, and reinforces the potentia ...

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 ...

I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum.BridgeBio (NASDAQ: BBIO ) announced the FDA approval of Attruby (acorami ...

- 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 ...