– The ASCEND-ATTR study builds on the Phase 3 ATTRibute-CM CMR substudy results previously shared here, which indicated treatment with acoramidis may improve cardiac structure and function with evidence of amyloid regression in a subset of patients – ATTR-CM has long been treated as a disease where progression can be slowed, but these findings raise the possibility that acoramidis may be capable of reversing progression and actively restoring heart health. TTR stabilization with acoramidis may allow the body’s natural amyloid clearance mechanisms to outpace amyloid formation, thereby enabling cardiac remodeling and functional recovery – ASCEND-ATTR will determine whether long-term acoramidis treatment is associated with sustained improvement in cardiac structural disease damage, function, and amyloid burden – Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the ESC Congress 2026 PALO ALTO, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that the first participant has been dosed in ASCEND-ATTR, a Phase 3b/4 study designed to further characterize the long-term effects of acoramidis on the improvement of cardiac structure, function, and amyloid burden in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer. “Serial cardiac imaging from the ATTRibute-CM CMR substudy gave us the first real signal that TTR stabilization can do more than slow disease progression, it may allow the heart to recover function and remodel favorably over time,” said Ahmad Masri, M.D., M.S. of Oregon Health and Science University. “ASCEND-ATTR will allow us to study these structural and functional changes prospectively and in far greater depth, across a notably larger patient cohort and with two complementary imaging modalities, to better understand the extent to which favorable remodeling can be achieved with long-term acoramidis treatment.” ASCEND-ATTR is a single-arm, prospective, longitudinal, open-label study that will enroll approximately 150 participants with ATTR-CM. Cardiovascular magnetic resonance (CMR) and cardiac echocardiography will be performed annually over 36 months. The primary efficacy endpoint is responder status at Month 36 by CMR, based on improvement from baseline in LV systolic function. Secondary endpoints include CMR measures of cardiac function, structure, and amyloid burden at Month 36, along with echocardiographic measures, circulating biomarkers, and imaging assessments at Months 12 and 24. This study reflects BridgeBio’s relentless pursuit in advancing care and addressing the unmet needs of the ATTR-CM community. The previously presented CMR substudy of ATTRibute-CM found treatment with acoramidis suggested disease improvement across multiple measurements of cardiac structure and function through month 30, including mean improvement from baseline in Left Ventricular Mass Index (LVMi), Left Ventricular Stroke Volume Index (LVSVi), and Left Ventricular Ejection Fraction (LVEF) with evidence of amyloid regression in a subset of patients. TTR stabilization with acoramidis may allow the rate of innate amyloid clearance mechanisms to exceed the rate of amyloid formation, thereby enabling cardiac remodeling and functional recovery. These findings suggest acoramidis may be capable of altering the trajectory of this otherwise progressive disease and actively restoring heart health. Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the European Society of Cardiology (ESC) Congress 2026. More information on ASCEND-ATTR (NCT07695701) can be found here on clinicaltrials.gov. About Attruby™ (acoramidis)INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATIONAdverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBio Pharma, Inc.BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. BridgeBio Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding acoramidis, including the potential for acoramidis to improve cardiac structure and function, promote cardiac remodeling and functional recovery, alter or reverse the progression of ATTR-CM, and restore heart health; the potential for TTR stabilization with acoramidis to allow innate amyloid clearance mechanisms to exceed the rate of amyloid formation and thereby enable cardiac remodeling and functional recovery; the design, conduct, enrollment, timing, endpoints and anticipated ability of ASCEND-ATTR to further characterize the long-term effects of acoramidis on cardiac structure, function and amyloid burden, including whether long-term treatment with acoramidis is associated with sustained improvement in cardiac structural disease damage, function and amyloid burden; and BridgeBio’s plans to present additional data from the CMR substudy of ATTRibute-CM and its open-label extension at future medical meetings. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials, including ASCEND-ATTR; the risk that results from subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed improvements in cardiac structure, function or amyloid burden may not be replicated in additional analyses or studies or translate into improved long-term clinical outcomes; that mechanistic interpretations of observed data, including the potential relationship between TTR stabilization, innate amyloid clearance, cardiac remodeling and functional recovery, may not be borne out by further analyses or additional data; that ASCEND-ATTR may not demonstrate sustained improvement in cardiac structure, function or amyloid burden or otherwise confirm the findings or therapeutic implications suggested by prior analyses; that plans to present additional data may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact: Kaitlyn Reilly, Director, Communicationscontact@bridgebio.com (650)-789-8220 BridgeBio Investor Contact: Kristen Kelleher, Director, Investor Relations ir@bridgebio.com
Other News
Kestra Appoints Curtis Kopf as Senior Vice President of Customer Experience
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Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
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Nanox to Report Second Quarter 2026 Financial Results on September 9, 2026
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Incuvate Files Patent Infringement Lawsuit Against Penumbra
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CVRx Responds to Letter from Pointillist Family Office
MINNEAPOLIS, Aug. 25, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today issued the following statement in response to the public letter to CVRx’s Board of Directors from Jorey Chernett at Pointillist Family Office, dated August 24, 2026: The Board of Directors and leadership team are committed to acting in the best interests of all CVRx shareholders and regularly evaluate a full range of options to maximize value for all shareholders. The Board values all shareholder input and appreciates the open dialogue the Company has maintained with Mr. Chernett. The Company agrees with Mr. Chernett that Barostim is a highly differentiated, validated therapy protected by a deep moat of clinical evidence, and it remains the only approved neuromodulation therapy for heart failure. The Company also shares Mr. Chernett’s view that CVRx’s current valuation does not fully capture the potential of the underlying business. The Board is confident in the fundamentals of the business and the Company’s strategies to drive Barostim growth while at the same time managing expenses. The Board is open to constructive engagement with all of its shareholders and will continue to pursue the best course of action consistent with its fiduciary duties to all shareholders. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner ICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
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R3 Vascular Expands Management Team with Two Senior Executives
Appointments Support Accelerated Trial Enrollment, Market Development, Scalability, and Future CommercializationMOUNTAIN VIEW, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of two senior executives as it accelerates trial enrollment, market development, scalability, and future commercialization. Robert Spanos has been appointed as Vice President, Global Market Development and Katie Segreto has been appointed as Vice President, Finance and Corporate Controller. Commenting on the appointments, Christopher M. Owens, President and CEO of R3 Vascular said, “On behalf of the R3 management team, I am very pleased to welcome Bob Spanos and Katie Segreto. Both bring exceptional expertise and proven leadership that will be instrumental as we advance the clinical development of MAGNITUDE®, accelerate our market presence, and build the infrastructure needed to support future commercialization. Bob’s deep experience in peripheral vascular markets and successful product launches will strengthen our commercial strategy and market expansion efforts, while Katie’s extensive finance leadership experience will help us scale our organization and position R3 Vascular for long-term growth. We are excited to have them join our team at this important stage for the company, including the recent rapid acceleration of our ELITE Clinical Trial enrollment, finalizing the advances in scaffold product line extensions, driving elite margin structure and setting the foundation throughout the organization to prepare for commercialization.” Robert Spanos is a seasoned cardiovascular medical device executive with more than 20 years of experience leading commercial strategy, clinical execution, and successful product launches across the endovascular and peripheral vascular markets. Throughout his career, he has built and led high-performance sales organizations while driving market adoption and revenue growth for innovative, first-to-market technologies. Prior to joining R3 Vascular, Robert held senior leadership roles including Executive Vice President of Corporate Operations for Emblok Inc., Vice President of Commercial Development at AngioDynamics, and Vice President of U.S. Sales Accounts at Eximo Medical, where he played a critical role in IDE trials, FDA 510(k) submissions, global commercial launches, and acquisition integrations. He has also served in key leadership positions at IDev Technologies, Mercator MedSystems, FoxHollow Technologies, and Guidant Endovascular Solutions, contributing to multiple successful product launches and strategic exits. He holds a Bachelor of Business Administration in Marketing from the University of St. Thomas. Robert Spanos said, “I’m excited to join the R3 Vascular team and contribute to the advancement of MAGNITUDE, a remarkable next-generational bioresorbable platform. Its ultra-high molecular weight polymer delivers strength and flexibility needed to address the unique demands of tibial vessels in patients with critical limb ischemia (CLTI), while offering potential applications in other vascular beds, including the superficial femoral and coronary arteries. I look forward to helping drive the successful execution of the company’s clinical, regulatory and commercial objectives.” Katie Segreto brings more than 18 years of finance leadership experience building and scaling high-performing finance organizations across the medical device, biotechnology, and technology sectors. She has guided both public and private companies through periods of substantial growth and transformation. Prior to joining R3 Vascular, Katie served as Vice President of Finance for Kronos Bio, a publicly traded clinical-stage biotechnology company, where she led the finance organization through the company’s post-IPO expansion. Previously, Katie served as Vice President of Finance at K Health, a venture-backed health technology company, where she built the finance function from the ground up, enabling the company’s growth from $0 to $20M in sales and through its Series C and D financings. Earlier in her career, Katie held finance leadership roles at Bonobos, a high-growth ecommerce company acquired by Walmart, and spent eight years in the Life Science audit practice at PwC, advising biotech and med tech companies on audit and accounting strategy. Katie holds a Bachelor of Arts in Business Management Economics from the University of California, Santa Cruz and is a Certified Public Accountant (inactive). Katie Segreto added, “I am thrilled to join the R3 Vascular team at such an important point in the company’s growth and to help advance this innovative bioresorbable technology. The platform’s potential to address important unmet needs and improve outcomes in vascular care is particularly compelling. I look forward to supporting the advancement of the company’s clinical and commercial objectives to ultimately bring this technology to the patients who need it most.” About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com


