Company Overview - BridgeBio Pharma Inc (NASDAQ: BBIO) develops treatments for genetic conditions [2] - The company's stock has increased by 46.5% since the previous article, primarily due to receiving approval for a treatment [2] Key Developments - BridgeBio Pharma Inc has experienced significant developments since the last analysis, contributing to its stock performance [2] Analyst Background - The author, Myriam Hernandez Alvarez, holds multiple degrees including a Ph.D. in computer applications and has a professional collaboration with Edgar Torres H [2]

Stock Performance - BridgeBio Pharma (BBIO) shares rallied 16% in the last trading session to close at $33 73, driven by notable trading volume [1] - The stock has gained 5 8% over the past four weeks [1] Financial Expectations - The company is expected to post a quarterly loss of $1 09 per share, representing a year-over-year change of -13 5% [2] - Revenues are expected to be $5 3 million, up 202 9% from the year-ago quarter [2] - The consensus EPS estimate for the quarter has been revised 4 1% lower over the last 30 days [3] Industry Comparison - BridgeBio Pharma is part of the Zacks Medical - Generic Drugs industry [3] - Bausch Health (BHC), another stock in the same industry, closed the last trading session 6 1% lower at $7 40 and has returned 0 9% in the past month [3] - For Bausch, the consensus EPS estimate for the upcoming report has changed +0 4% over the past month to $1 12, representing a change of -2 6% from the year-ago quarter [4] Drug Development and Commercial Progress - The stock price rise was attributed to encouraging commercial progress for its recently approved drug, Attruby (acoramidis), pipeline progress, and expected 2025 milestones [5] - Attruby received FDA approval in November 2024 as a near-complete TTR stabilizer to reduce cardiovascular death and cardiovascular-related hospitalization in adult patients with transthyretin amyloid cardiomyopathy [5] - The company has witnessed remarkable momentum for the drug with 430 patient prescriptions written by 248 physicians [5] - Approvals in other geographies for the same indication are anticipated in 2025 [5]

Commercial Progress and FDA Approval - Attruby (acoramidis) received FDA approval on November 22, 2024, marking a significant milestone for the company and the ATTR-CM patient community [1][8] - Since approval, 430 prescriptions have been written by 248 unique physicians, indicating strong initial commercial momentum [1][7][8] - Attruby is indicated to reduce cardiovascular death and cardiovascular-related hospitalization in adult patients with ATTR-CM, a progressive fatal disease [8][10] Pipeline Updates and Clinical Trials - The company has completed enrollment for all three major Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) [2][7][9] - FORTIFY, a Phase 3 trial for BBP-418, is fully enrolled with 112 patients, with Last Patient – Last Visit (LPLV) and topline readout expected in the second half of 2025 [9] - CALIBRATE, a Phase 3 trial for encaleret, is fully enrolled with 70 patients, with LPLV and topline readout expected in the second half of 2025 [9] - PROPEL 3, a Phase 3 trial for infigratinib, is fully enrolled with 114 participants, with Last Participant – Last Visit expected in the second half of 2025 [9] Financial and Regulatory Milestones - The company is well-financed with $406 million in cash as of the last quarter and received $500 million upon FDA approval of acoramidis from a royalty facility [7] - Anticipated regulatory milestones include $105 million in the first half of 2025 from acoramidis approvals in Europe and Japan [7] - EU and Japan approvals for acoramidis are expected in the first half of 2024 [3] Product Potential and Market Impact - If successful, BBP-418 would be the first approved therapy for LGMD2I/R9, a rare genetic disorder causing progressive muscle degeneration [9] - Encaleret could become the first approved therapy for ADH1, a rare genetic form of hypoparathyroidism [9] - Infigratinib has the potential to be the first approved oral therapy for children with achondroplasia, the most common form of disproportionate short stature [9] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on discovering and delivering transformative medicines for genetic diseases [11] - Founded in 2015, the company has a pipeline ranging from early science to advanced clinical trials [11]

PALO ALTO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced that co-founder and CEO, Neil Kumar, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT. To access the live webcast of BridgeBio’s presentation, please visit the “Events & Presentations” page within the Investors section of t ...

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 ...