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BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM
GlobeNewswire News Room· 2025-04-28 09:00
Core Insights - The UK has granted marketing authorization for acoramidis, branded as BEYONTTRA, for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [1][2] - Acoramidis is the first and only approved treatment for ATTR-CM in the U.S., EU, UK, and Japan, with a label specifying near-complete stabilization (≥90%) of transthyretin (TTR) [1][3] - The approval is based on positive results from the Phase 3 ATTRibute-CM study, which demonstrated significant cardiovascular benefits [2][3] Summary by Category Product Approval - The Medicines and Healthcare products Regulatory Agency in the UK has approved acoramidis for ATTR-CM treatment [1][2] - Acoramidis has previously received approvals in the U.S. as Attruby™ and in the EU and Japan as BEYONTTRA [3] Clinical Study Results - The ATTRibute-CM study involved 632 participants and showed a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30 compared to placebo [1][2] - A 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events was also observed at Month 30 [1] Market and Financial Aspects - BridgeBio will receive royalties in a tiered structure starting in the low-thirties percent on sales of BEYONTTRA in the UK [1][4][5] - Bayer is responsible for all commercial activities related to acoramidis in the UK [1][3]
SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of BridgeBio Pharma, Inc. (NASDAQ: BBIO)
Prnewswire· 2025-04-23 15:00
Core Viewpoint - Purcell & Lefkowitz LLP is investigating BridgeBio Pharma, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is on behalf of BridgeBio Pharma's shareholders [1]. - The law firm specializes in representing shareholders affected by securities fraud and breaches of fiduciary duty [3]. - Shareholders seeking more information can contact the firm for free [2].
BridgeBio to Host First Quarter 2025 Financial Results Conference Call on Tuesday, April 29, 2025 at 4:30 pm ET
Newsfilter· 2025-04-22 11:30
PALO ALTO, Calif., April 22, 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 it will release its first quarter financial results and program updates after the market closes on Tuesday, April 29, 2025. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, ...
Acoramidis Shows Statistically Significant Improvements in Cardiovascular Outcomes in Patients with Variant ATTR-CM
Newsfilter· 2025-03-31 14:00
PALO ALTO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today presented results showing statistically significant improvements in clinical outcomes as compared to placebo for time to all-cause mortality (ACM) or first cardiovascular-related hospitalization (CVH) in both variant (ATTRv) and wild-type (ATTRwt) transthyretin amyloid cardiomyopathy (ATTR-CM) patients from a pre ...
Beyonttra™ (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved in Japan to Treat ATTR-CM
Newsfilter· 2025-03-27 11:00
Core Viewpoint - BridgeBio Pharma has received approval from the Japanese Ministry of Health for acoramidis, branded as Beyonttra, to treat adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), marking a significant advancement in treatment options for this progressive and fatal disease [1][2]. Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on developing treatments for genetic diseases, founded in 2015. The company aims to deliver transformative medicines through a pipeline that includes early science to advanced clinical trials [9]. Product Details - Acoramidis is a selective small molecule, orally administered, and is a near-complete (≥90%) stabilizer of transthyretin (TTR). It has shown potential in reducing all-cause and cardiovascular mortality risks [1][6]. - The drug was well-tolerated in clinical trials, with a reported 0% mortality during a 30-month treatment period in the Japanese Phase 3 study [3][8]. Clinical Trial Results - The approval in Japan was based on positive outcomes from a Phase 3 open-label study and the global ATTRibute-CM Phase 3 trial. Key findings include: - Early separation in time to first event (all-cause mortality or cardiovascular-related hospitalization) at 3 months compared to placebo [3][8]. - A 42% reduction in composite all-cause mortality and recurrent cardiovascular hospitalization events at Month 30 relative to placebo [3][8]. - A 50% reduction in cumulative frequency of cardiovascular hospitalization events at Month 30 compared to placebo [3][8]. Commercialization and Financials - Alexion, AstraZeneca Rare Disease holds an exclusive license to develop and commercialize acoramidis in Japan. BridgeBio will receive a $30 million milestone payment upon approval and low double-digit royalties on sales [4][8].
BridgeBio to Present Cardiovascular Outcomes Data in Patients with Variant and Wild-type Transthyretin Amyloid Cardiomyopathy (ATTR-CM) from the ATTRibute-CM Study at the ACC Annual Scientific Sessions
Newsfilter· 2025-03-24 11:30
Core Insights - BridgeBio Pharma announced the presentation of cardiovascular outcomes data from its Phase 3 study of acoramidis in patients with ATTR-CM at the ACC Annual Scientific Sessions & Expo in March 2025 [1] Group 1: Presentation Details - Acoramidis improves serum TTR levels in patients with wild-type or variant transthyretin amyloid cardiomyopathy [2] - Acoramidis improves NYHA class at month 30 versus placebo in patients with ATTR-CM [2] - Addition of concomitant tafamidis did not further increase serum TTR levels in participants treated with acoramidis [3] - Efficacy results of acoramidis in ATTR-CM were robust according to pre-specified NT-proBNP sensitivity analyses [3] - Acoramidis-mediated early increase in serum transthyretin level reduces cardiovascular-related hospitalizations and mortality [3] Group 2: Moderated Posters - Primary endpoint efficacy results in the ATTRibute-CM study addressed tafamidis use [4] - Geographic healthcare disparities and diagnostic trends among patients with transthyretin amyloid cardiomyopathy [4] Group 3: Product Information - Attruby (acoramidis) is the first near-complete stabilizer of TTR approved in the U.S. for treating ATTR-CM in adults [5] - Attruby aims to reduce cardiovascular death and related hospitalizations and was generally well-tolerated with mild side effects [5] Group 4: Company Overview - BridgeBio Pharma focuses on discovering, creating, testing, and delivering transformative medicines for genetic diseases [6] - The company was founded in 2015 and has a pipeline ranging from early science to advanced clinical trials [6]
BridgeBio Announces CFO Succession
GlobeNewswire News Room· 2025-03-17 20:01
Core Insights - BridgeBio Pharma, Inc. has appointed Thomas Trimarchi, Ph.D. as President and Chief Financial Officer, who will continue to oversee FP&A and accounting operations [1] - Brian Stephenson, Ph.D. is departing from the company for personal reasons but will remain as a consultant [2] - Dr. Stephenson expressed pride in his contributions to the company and its innovative financial model aimed at serving patients with genetic diseases [3] Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases [4] - The company was founded in 2015 and has a pipeline that includes programs from early science to advanced clinical trials [4] - The team is dedicated to applying advances in genetic medicine to expedite patient care [4]
Prediction: BridgeBio Pharma Will Beat the Market. Here's Why
The Motley Fool· 2025-03-04 00:00
Core Insights - The Motley Fool aims to enhance the financial literacy and well-being of individuals by providing investment solutions and market analysis [1] Company Overview - Founded in 1993, The Motley Fool is a financial services company focused on making the world smarter, happier, and richer [1] - The company reaches millions of people monthly through various platforms, including premium investing solutions, free guidance, and market analysis on Fool.com [1] - The Motley Fool also produces top-rated podcasts and operates a non-profit organization, The Motley Fool Foundation [1]
BridgeBio Prices Offering of $500 Million Convertible Senior Notes due 2031 to Refinance Senior Secured Debt
Globenewswire· 2025-02-26 07:49
Core Viewpoint - BridgeBio Pharma, Inc. has announced the pricing of $500 million aggregate principal amount of 1.75% convertible senior notes due 2031, with an option for initial purchasers to buy an additional $75 million [1][2] Group 1: Financial Details - The estimated net proceeds from the sale of the notes will be approximately $489.5 million, or about $563.0 million if the option for additional notes is fully exercised [2] - A portion of the net proceeds will be used to repay all outstanding borrowings under a Financing Agreement, which accounted for approximately $51.5 million of cash paid for interest in 2024 [2] - Approximately $48.3 million of the remaining net proceeds will be used to repurchase 1,405,411 shares of common stock at a price of $34.35 per share [3] Group 2: Notes Structure - The notes will bear interest at a rate of 1.75% per year, payable semi-annually, and will mature on March 1, 2031 [4] - The initial conversion rate will be 20.0773 shares per $1,000 principal amount of notes, equating to an initial conversion price of approximately $49.81 per share, representing a 45% premium over the last reported sale price [5][7] - Holders of the notes will have the right to require the Company to repurchase their notes at 100% of their principal amount upon certain events [8] Group 3: Redemption and Ranking - The Company may not redeem the notes prior to March 6, 2028, and can redeem them under specific conditions thereafter [6] - The notes will rank senior in right of payment to any unsecured indebtedness that is subordinated and equal in right of payment to other unsecured indebtedness [9]
BridgeBio Initiates Long Term Debt Management Strategy and Announces Proposed Offering of Convertible Senior Notes to Refinance Senior Secured Debt
Globenewswire· 2025-02-24 21:09
Core Viewpoint - BridgeBio Pharma, Inc. plans to offer $500 million of convertible senior notes due 2031 to strengthen its balance sheet and manage long-term debt without increasing total liabilities [1][2] Group 1: Offering Details - The company intends to offer $500 million aggregate principal amount of convertible senior notes due 2031, with an option for initial purchasers to buy an additional $75 million [1] - The notes will bear interest semi-annually and will mature on March 1, 2031, with specific conditions for conversion prior to December 2, 2030 [4] - The final terms, including conversion rate and interest rate, will be determined at the time of pricing [4] Group 2: Use of Proceeds - A portion of the net proceeds will be used to repay all outstanding borrowings under a Financing Agreement, which accounted for approximately $51.5 million in interest paid in 2024 [2] - Up to $50 million of remaining net proceeds will be used for share repurchases of common stock from certain purchasers of the notes [2] - Any remaining net proceeds will be allocated for general corporate purposes [2] Group 3: Debt Management Strategy - The refinancing of the term debt facility is expected to lower interest expenses, eliminate near-term amortization payments, and significantly extend debt maturity [1] - The notes will rank senior in right of payment to any unsecured indebtedness that is subordinated and will be effectively junior to secured indebtedness [6] Group 4: Market Impact - Share repurchases could influence the market price of the company's common stock and potentially result in a higher effective conversion price for the notes [3] - The company cannot predict the magnitude of market activity or its overall effect on the market price of the notes or common stock [3]