Market Newsdesk

SAN DIEGO, Oct. 11, 2026 (GLOBE NEWSWIRE) — First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, will host an investor call and live webcast to review top-line data from Cohort 1, a gluten-challenge study assessing prevention of mucosal damage, of the global Phase 1b trial of investigational ANB033, a CD122 antagonist, in celiac disease on Monday, Oct. 12, 2026, at 8:30am ET/5:30am PT.

A live webcast of the call will be available on the First Tracks website at: https://ir.firsttracksbio.com/news-events/events. The data will be provided in a morning press release and presented during the webcast. A replay of the webcast will be available for at least 30 days following the event.

About First Tracks Biotherapeutics

First Tracks Biotherapeutics is a clinical stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn.

Investor Contact:

Nick Montemarano
Vice President, Investor Relations
858.732.0178
[email protected]

– In an independent, propensity score-matched analysis of 2,684 individuals living with ATTR-CM from Epic COSMOS, the largest U.S. electronic health record database, acoramidis was associated with a statistically significant 18% lower risk of a composite of death, all-cause hospitalization, new-onset atrial fibrillation, and diuretic intensification versus tafamidis (HR 0.82; 95% CI 0.73-0.93; p<0.01)

– Early separation of the composite curves was noted within one month in this contemporary cohort of patients from 2025, with consistent results across unadjusted, matched, and biomarker-adjusted analyses

– Acoramidis was associated with significant reductions in hospitalization, among the outcomes that matter most to people living with ATTR-CM, with a 27% lower risk of cardiovascular hospitalization, 27% lower risk of heart failure hospitalization, and 25% lower risk of all-cause hospitalization as compared to tafamidis (all p<0.001) 

– These findings replicate the earlier Wright et al. Komodo claims analysis published in

Cardiology and Therapy

, in which acoramidis was associated with a 34% reduction in clinical worsening events versus tafamidis (p=0.046), making this the second real-world comparative effectiveness analysis, and the first in electronic health records, to favor acoramidis, supporting the reproducibility of the benefit

– ATTRibute-CM data also presented at HFSA underscore the importance of hospitalization reduction: mortality risk approximately doubled after a single cardiovascular hospitalization and quadrupled after two or more, making hospitalization prevention a central treatment goal in ATTR-CM

– Together, these data have the potential to inform the use of acoramidis as the stabilizer of choice, both in newly diagnosed patients and in those on other disease-modifying agents

PALO ALTO, Calif., Oct. 11, 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 that new, independent and contemporary real-world evidence as well as Phase 3 ATTRibute-CM sub-analyses of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2026 in Phoenix, Arizona. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

“In a prior real-world claims analysis, acoramidis was associated with fewer diuretic intensification events, suggesting the possibility of greater clinical stability on acoramidis, but this obviously needed to be interpreted with caution. This new, larger, electronic health record study of nearly 2,700 individuals with ATTR-CM with longer follow-up and more granular data is better able to address the question, and shows a similar signal, with a significant difference in rates of cardiovascular or heart failure hospitalizations favoring acoramidis compared to tafamidis, with approximately one quarter lower risk of events,” said David Lanfear, M.D., M.S., Chief Scientific Officer, Vice President of Research at Henry Ford Health, U.S. “While electronic health record studies have well-recognized limitations, these data allow us to see how these therapies perform outside of a clinical trial, across a diverse and contemporary patient population. Moreover, there appears to be some consistency of findings across data sources and endpoints, supporting validity. Additional investigations to replicate and extend these findings are warranted.”

In a retrospective analysis conducted and presented by Dr. Lanfear, individuals with ATTR-CM newly initiating acoramidis had lower rates of adverse cardiac outcomes than individuals newly initiating tafamidis. The study leveraged data from Epic COSMOS, the largest U.S. electronic health record database, with over 300 million patients. This dataset includes detailed, anonymized clinical records captured in the course of routine patient care, such as laboratory values and medication records. After matching, 910 acoramidis-treated and 1,774 tafamidis-treated individuals were included, with similar baseline characteristics across treatment groups. Key findings included:

• The composite endpoint of death, all-cause hospitalization, new-onset atrial fibrillation, or diuretic intensification was significantly lower with acoramidis across all three analyses: unadjusted (HR 0.82; 95% CI 0.72-0.90; p<0.001), primary (18% lower risk; HR 0.82; 95% CI 0.73-0.93; p<0.01), and a sensitivity analysis adjusting for a combined standardized NT-proBNP and BNP variable where available (HR 0.84; 95% CI 0.72-0.97; p=0.02)
• Acoramidis-treated individuals had statistically significantly lower rates of hospitalization than tafamidis-treated individuals, including a 27% lower risk of cardiovascular hospitalization (HR 0.73; 95% CI 0.62-0.86; p<0.001), a 27% lower risk of heart failure hospitalization (HR 0.73; 95% CI 0.62-0.87; p<0.001), and a 25% lower risk of all-cause hospitalization (HR 0.75; 95% CI 0.64-0.88; p<0.001)
• Diuretic intensification, an early marker of disease progression, was 17% lower with acoramidis (HR 0.83; 95% CI 0.71-0.95; p<0.01). Diuretic intensification was defined as use of parenteral loop diuretics, initiation or dose-equivalent escalation of oral loop diuretics, or use of a thiazide-like diuretic
• Differences in death (HR 0.85; 95% CI 0.62-1.20; p=0.34) and new-onset atrial fibrillation (HR 0.88; 95% CI 0.68-1.13; p=0.31) numerically favored acoramidis, consistent with the composite, but did not reach statistical significance, reflecting lower event counts and limited duration of follow-up for these longer-term endpoints. These endpoints will be reassessed as the cohort matures
• Kaplan-Meier time-to-event curves for the composite endpoint showed early and sustained separation between treatment groups over follow-up (p=0.0014)
• The consistency of the treatment effect across unadjusted, matched, and biomarker-adjusted analyses and across multiple clinical outcomes supports the robustness of the observed difference

These findings in electronic health record data replicate and expand on the results of the first peer-reviewed, claims-based real-world comparative effectiveness study of TTR stabilizers in ATTR-CM, in which acoramidis was associated with a 34% reduction in a composite of clinical worsening events (diuretic intensification, heart failure hospitalization, and mortality) versus tafamidis (p=0.046), supporting the reproducibility of the observed benefit across independent data sources and data types.

As with all observational studies, there are inherent limitations. Although propensity-score matching balanced patient baseline characteristics and results remained consistent across both unweighted and sensitivity analyses, the possibility of residual confounding cannot be fully excluded. Follow-up was relatively short due to recent approval of acoramidis, which limited the number of events available to assess less frequent outcomes, such as mortality. These factors would not be expected to affect one treatment group differently than the other, and the consistency of results across multiple endpoints and in multiple studies supports the robustness of the findings. As data continue to mature, additional analyses with longer follow-up periods will be shared. The full results of this analysis are currently under peer-review by a journal.

Three additional analyses presented at HFSA ASM 2026 continued to reinforce the acoramidis narrative, reaffirming the importance of reducing cardiovascular-related hospitalizations (CVH) in ATTR-CM, the differentiated cardiorenal impact of acoramidis, and the benefit of acoramidis within variant ATTR-CM patients:

• 
  Cardiovascular-related hospitalizations associated with higher risk of mortality:
  
  Association Between the Burden of CVH and All-Cause Mortality (ACM) in Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM, presented by Quan Bui, M.D. of UC San Diego Health, U.S.
  • In this post hoc analysis of ATTRibute-CM (pooled treatment groups; N=611), fewer than half of participants who experienced two or more cardiovascular-related hospitalizations were alive at 30 months. Survival fell from 86.7% in participants with no CVH events to 68.4% with one and 47.7% with two or more (log-rank p<0.0001)
  • Mortality risk approximately doubled after a single hospitalization and quadrupled after two or more, establishing CVH burden as a marker of subsequent mortality risk and reinforcing hospitalization prevention as a clinically meaningful treatment goal in ATTR-CM
  • Acoramidis reduced the annualized frequency of CVH by 50% through Month 30 versus placebo (p < 0.0001), with Kaplan-Meier curves for time to first CVH separating from Month 3
• 
  Unique cardiorenal impact of acoramidis:
  
  Early eGFR Dip Following Acoramidis Initiation is Associated With Reduced Risk of Mortality and Recurrent Cardiovascular-Related Hospitalizations in ATTR-CM, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S.
  • In the ATTRibute-CM study, acoramidis-treated participants with a greater Day 28 eGFR dip following treatment initiation were associated with a significantly reduced risk of mortality or recurrent CVH versus placebo, with no clinically concerning changes observed in laboratory parameters or blood pressure
  • These findings provide additional context for the reported association between greater early eGFR decline and improved first CVH outcomes with acoramidis, and build upon the 42% reduction in recurrent CVH/ACM previously demonstrated with acoramidis over placebo in ATTRibute-CM
  • These results build upon analyses previously published in Circulation: Heart Failure; details on results can be found here
• 
  Acoramidis benefit in p.Val142Ile variant patients:
  
  Acoramidis Preserves Functional Capacity and Quality of Life in p.Val142Ile Variant Transthyretin Amyloid Cardiomyopathy: Results from ATTRibute-CM, presented by Lily Stern, M.D. of Cedars-Sinai Heart Institute, U.S.
  • In this post hoc analysis of 35 ATTRibute-CM participants with the p.Val142Ile variant (acoramidis, n = 23; placebo, n = 12), acoramidis significantly attenuated 30-month declines in heart failure-related health status and quality of life versus placebo: differences of 23.3 points in KCCQ-OS score (p = 0.005), 25.8 points in EQ VAS score (p = 0.003), and 0.26 in EQ-5D-5L index score (p = 0.018), each several-fold above published thresholds for clinically meaningful change.
  • Decline in 6-minute walk distance was numerically smaller with acoramidis (LSM difference: 67.2 m; p = 0.136)
  • These findings complement the previously reported 69% reduction in the risk of all-cause mortality or first cardiovascular-related hospitalization with acoramidis through Month 30 in this subgroup

In addition to the two rapid-fire oral presentations, one oral presentation, and one poster presentation highlighted, there was one additional rapid-fire oral presentation and five additional poster presentations along with four encore poster presentations shared at HFSA ASM 2026, which included:

• Ratio of Serum Transthyretin to NT-proBNP is a Novel Prognostic Measure for Transthyretin Amyloid Cardiomyopathy: Insights from ATTRibute-CM, presented by James L. Januzzi, M.D. of Massachusetts General Hospital, U.S. and simultaneously published in JACC: Heart Failure
  • In ATTR-CM, early acoramidis-mediated sTTR increases were associated with later NT-proBNP decreases. The Day 28 sTTR to Month 12 NT-proBNP ratio, integrating early pharmacodynamic response with downstream cardiac stress, is a prognostic biomarker of clinical risk in ATTR-CM
• Falls and Fractures Drive Increased Hospitalizations and Costs in Patients with Transthyretin Amyloid Cardiomyopathy Compared with Controls, presented by Nitasha Sarswat, M.D. of University of Chicago, U.S.
  • ATTR-CM was associated with increased falls and fall-related consequences, including fractures, bleeding after a fall, discontinuation of oral anticoagulant use, and related hospitalizations and costs, compared with matched heart failure (HF) and non-HF controls, consistent with substantial disease burden beyond cardiac manifestations and with higher healthcare resource utilization
• Evaluating the Long-Term Effects of Acoramidis on Cardiac Function, Structure, and Amyloid Burden in Transthyretin Amyloid Cardiomyopathy: ASCEND-ATTR, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S.
  • ASCEND-ATTR will determine whether long-term transthyretin stabilization is associated with sustained improvement in myocardial structure, function, and amyloid burden. By integrating serial CMR and echocardiography, the study aims to provide mechanistic insights into cardiac remodeling during treatment and help define imaging biomarkers of therapeutic response
• Real-World Burden of Transthyretin Amyloid Cardiomyopathy Disease and Outcomes in Patients on Tafamidis Prior to Initiating Acoramidis, presented by Richard Wright, M.D. of Pacific Heart Institute, U.S.
  • Nearly half of patients receiving tafamidis exhibited markers of ATTR-CM clinical worsening within the 6 months preceding acoramidis initiation. This burden appears higher than previously reported real-world disease progression rates after tafamidis initiation and warrants further study. Future research should evaluate drivers of switching therapy and outcomes after transitioning to acoramidis
• Acoramidis Reduces Risk of Cardiovascular-related Mortality and Hospitalization in Women with Transthyretin Amyloid Cardiomyopathy, presented by Margot Davis, M.D. of University of British Columbia, Vancouver, Canada
  • Among women enrolled in ATTRibute-CM, who entered the trial older and with a more advanced clinical phenotype than men, acoramidis reduced the risk of cardiovascular mortality or first cardiovascular-related hospitalization through Month 30 and attenuated the rise in NT-proBNP versus placebo. Treatment effects in women aligned with the overall population, with no significant treatment-by-sex interaction. This may represent the first reported analysis from a phase 3 ATTR-CM trial to show a nominally statistically significant treatment effect for this endpoint among women. While the small number of women enrolled limits precision, these findings support the efficacy of acoramidis in women and underscore the need for adequately powered, sex-informed evidence in ATTR-CM
• Effect of Acoramidis on Heart Failure-Related Health Status Before and After Cardiovascular-Related Hospitalization: Insights from ATTRibute-CM, presented by Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S.
  • Worsening KCCQ-OS precedes CVH and may serve as an early indicator of an adverse outcome in patients with ATTR-CM. Following a CVH event, acoramidis was associated with recovery of health status versus continued decline observed with placebo, suggesting a beneficial effect on post-CVH health status trajectory

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Additional data on the benefit of Attruby for individuals with ATTR-CM is planned for future medical meetings.

About
Attruby® (acoramidis)

INDICATION

Attruby 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 INFORMATION

Adverse Reactions

Diarrhea (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

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 Statements

This 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, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. 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 real-world and ATTRibute-CM data regarding acoramidis, including the potential for the findings to inform treatment selection for newly diagnosed patients and patients currently receiving other disease-modifying therapies and to support switching individuals to acoramidis; the potential reproducibility, durability and broader clinical significance of observed benefits associated with acoramidis across independent data sources, including with respect to cardiovascular and heart failure hospitalizations, clinical stability and other outcomes; the potential clinical and therapeutic implications of the ATTRibute-CM analyses, including with respect to cardiovascular hospitalization, cardiorenal outcomes, biomarkers, health status and outcomes in patient subgroups; the design, conduct and anticipated findings of ASCEND-ATTR, including whether long-term TTR stabilization is associated with sustained improvement in myocardial structure, function and amyloid burden and the potential to identify imaging biomarkers of therapeutic response; and BridgeBio’s plans and expectations regarding additional analyses, longer-term follow-up, future research, publications and presentations of data regarding acoramidis. 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, the risk that results from retrospective, observational, real-world evidence studies, including studies based on electronic health records or administrative claims data, may be subject to confounding, selection bias, residual bias, incomplete or inaccurate data, limited follow-up or other limitations and may not be predictive of future clinical outcomes or treatment effects; that observed associations and differences between acoramidis and tafamidis may not be replicated in additional analyses, independent studies or longer-term data or may not translate into improved long-term clinical outcomes; that results from post hoc analyses, subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects and may not be replicated in additional analyses or studies; that observed effects on cardiovascular hospitalizations, cardiorenal outcomes, biomarkers, health status or outcomes in patient subgroups may not be replicated or translate into meaningful long-term clinical benefit; that the findings may not meaningfully inform treatment selection or support switching patients to acoramidis; that mechanistic or prognostic interpretations of observed data, including potential relationships among TTR stabilization, cardiac remodeling, cardiorenal effects, biomarkers and clinical outcomes, may not be borne out by further analyses or additional data; that ASCEND-ATTR may not demonstrate sustained improvement in myocardial structure, function or amyloid burden or identify useful imaging biomarkers of therapeutic response; that additional analyses, longer-term follow-up or future research may yield results that differ from or do not confirm the findings described in this press release; that plans or timing for future analyses, medical meeting presentations or scientific publications may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine 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, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:

Kristen Kelleher, Director, Investor Relations
[email protected]

•    Stellantis offered an exclusive preview of six of the nine concept cars set to debut at the Paris Motor Show, October 12-18 

•    Alfa Romeo, Citroën, DS Automobiles, FIAT, Opel and PEUGEOT showcased how creativity and innovation enable emotion, serve people and enhance freedom of choice

•    Stellantis Chairman John Elkann, CEO Antonio Filosa and

Enlarged Europe COO Emanuele Cappellano highlighted

how FaSTLAne 2030 strategic plan is translating into tangible results, through technologies, products and  innovations with the customer at the center

•    Gilles Vidal, Head of Design, Enlarged Europe, presented the concept cars, illustrating how Stellantis is challenging conventions and accelerating towards the future

•    “The Night Before” offered a preview of Stellantis’ bold presence at the Paris Motor Show, featuring the exhibition’s largest booth, with more than 60 vehicles on display, nine concept cars, eight brands and six premieres

PARIS, October 11, 2026 – On the eve of the Paris Motor Show, Stellantis welcomed guests and media to “The Night Before”, an exclusive event at the iconic Hangar Y, in Paris. The event unveiled Stellantis’ vision for the future through six bold concept cars presented in world premiere. Marking the first step in Stellantis’ Paris Motor Show presence, the event set the stage for a stunning experience with over 60 vehicles on the largest stand at the auto show.

Developed under the leadership of Gilles Vidal, Head of Design, Enlarged Europe, these six concepts, representing six different iconic Stellantis brands, illustrate diverse paths to innovation. “With these six concept cars, we are expressing a shared conviction: the future of automotive design must be both bold and meaningful. Each concept explores new ways to enhance everyday experiences while reinforcing the unique identity of its brand. Together, they demonstrate how creativity, innovation and emotion can come together to make people fall in love with cars again,” said Vidal.

“This event brings our FaSTLAne 2030 strategy to life,” said CEO Antonio Filosa. “It reflects the extraordinary effort of our teams and our commitment to shaping the future of mobility through iconic brands, compelling design and innovative technology, giving customers more choice and more reasons to be excited about what’s ahead.”

Stellantis’ extensive presence at the Paris Motor Show, featuring eight of its brands, including key partner Leapmotor, offers a glimpse of the strength, innovation and ambition driving the Company’s transformation. “Stellantis is deeply rooted in Europe and holds a leading position that will be strengthened by the success of all our brands,” said Enlarged Europe COO Emanuele Cappellano.

“Stellantis wants to fully leverage the competitive advantage set by its iconic brands’ uniqueness, offering cars that are at once rooted in heritage and future-driven, based on robust know-how and distinguished by their unmatched design beauty, to shape the future of mobility with more than 50 products to be launched by 2030. These achievements, based on the execution of our strategic plan, will enable Stellantis to expand its market coverage in Enlarged Europe by 25%,” added Cappellano.

Each concept explores a distinct dimension of progress – from mobility and performance to well-being and digital experiences. Together, they embody the creativity, ambition and customer-focused vision propelling Stellantis into the future.

Alfa Romeo Cuorerosso
is a concept car born from the heart of the brand, created for those who still love driving. It shows how the brand can move into the future: a vision destined to find expression in the key segments of the market, through multi-energy architectures, with models up to 4.7 meters long and the potential to accommodate Quadrifoglio versions. With this in mind, the epitome of performance can be imagined through a 2.9 V6 Full-Hybrid powertrain, paired with Q4 all-wheel drive, torque converter, and carbon fiber driveshaft.

With the 2 CV Concept, Citroën is not replicating an icon: it is reinventing an idea that has lost none of its relevance. A more accessible, simpler and ingenious electric car that puts freedom and joy back at the heart of mobility. A new 2 CV, faithful to the spirit of the original yet designed for tomorrow: fully electric, made in Europe and accessible at a price of €15,000.

DS F3VER
 design-led concept explores the future of DS Automobiles, bringing together what too often comes separately: uncompromising desirability, personalization and versatility. Relying on these three fundamental pillars, DS F3VER breaks away from conventions to explore new possibilities and challenge established codes. A bold expression of where DS Automobiles is heading: more distinctive, more desirable and more daring.

FIAT Multiplay reimagines mobility for a new era, exploring how a vehicle can adapt seamlessly to the evolving needs of modern life. Combining the versatility of a pickup with the comfort and flexibility of an SUV, it challenges traditional automotive categories through a configurable architecture designed around people and shared experiences. Inspired by the groundbreaking Multipla, Multiplay offers a bold vision of FIAT’s future, bringing accessibility, inclusiveness and innovation together to reimagine mobility.

The Opel STX Concept  presents a vision for future estate cars, showcasing bolder, purer and even more emotional German design. The new Opel Vizor lighting signature with lamella light animations and even more prominent vertical Opel Compass, combined with the clean, downward-sloping rear, hint at the brand’s next generation design language, elements of which will feature in future production models.  

PEUGEOT RCZ
Vision
is a brand manifesto that gives the most advanced vision yet of PEUGEOT’s future, combining design and technology at the service of driving pleasure.   Built on an architecture based on the STLA One platform, the RCZ Vision benefits from the new steer-by-wire technology. It gives a preview of the next generation of the PEUGEOT onboard experience, notably through Hypersquare® and an all-new PEUGEOT i-Cockpit®.  It embodies PEUGEOT’s vision of high-performance and efficient electric mobility.  

# # #

About Stellantis

Stellantis (NYSE: STLA / Euronext Milan: STLAM / Euronext Paris: STLAP) is a leading global automaker, dedicated to giving its customers the freedom to choose the way they move, embracing the latest technologies and creating value for all its stakeholders. Its unique portfolio of iconic and innovative brands includes Abarth, Alfa Romeo, Chrysler, Citroën, Dodge, DS Automobiles, FIAT, Jeep

_®

, Lancia, Maserati, Opel, Peugeot, Ram, Vauxhall, Free2move and Leasys. For more information, visit

www.stellantis.com

	@Stellantis		Stellantis		Stellantis		Stellantis
For more information, contact: Alessandro NARDIZZI – [email protected] [email protected] www.stellantis.com

– Significant performance improvement seen across all subtypes of advanced precancerous lesions, which are important to detect for potential colorectal cancer prevention –

– Overall detection of colorectal cancer remained consistent with test’s first version, achieving 80.4% sensitivity at 90% specificity –

BRISBANE, Calif., Oct. 11, 2026 (GLOBE NEWSWIRE) — Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, today announced the company will present late-breaking data on an updated version of its SimpleScreen™ CRC blood-based screening test at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville.

Freenome conducted a pivotal clinical validation study to assess the performance of assay and algorithm improvements for the updated version of SimpleScreen CRC. The FDA approved the first-generation version of SimpleScreen CRC in July 2026, and the test was commercially launched in late September in the United States by Freenome’s partner Abbott Cancer Diagnostics.

The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions (APLs), a significant improvement compared to the 13.7% sensitivity in the original PREEMPT CRC^® study.¹ Sensitivity for APLs with high-grade dysplasia (HGD) improved to 41.9% in the updated test, compared to 30.5% reported previously. The sensitivity results for APLs and APLs with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

Sensitivity was also improved for all APL subtypes, including villous or tubulovillous; adenomas ≥ 10 mm; sessile serrated lesions/polyps ≥ 10 mm; and traditional serrated adenomas.

Overall, 80.4% sensitivity was demonstrated for detecting CRC. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

“These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity,” said Aaron Elliott, Ph.D., CEO of Freenome. “The ability to continually improve performance through refinements to our assay and algorithm, as seen with these results, is a fundamental part of our up-versioning strategy. We believe this iterative methodology not only improves CRC APL performance but is also applicable across our multi-cancer pipeline. Combined with our personalized cancer detection approach, this is how we continue to expand blood-based screening into an accessible option for the millions of Americans who remain unscreened.”

Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, will present the detailed results.

Presentation title: Improved Sensitivity for Advanced Precancerous Lesions (APLs) Demonstrated in Clinical Validation of an Updated Colorectal Cancer (CRC) Screening Blood Test in an Average-Risk Population.

Date: Wednesday, Oct. 14
Time: 9:10-9:20 am
Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD

About Freenome

Freenome is an early cancer detection company developing blood-based screening tests to identify cancer in its earliest, most treatable stages. The company’s proprietary multiomics discovery platform analyzes circulating cell-free DNA methylation patterns at single-base resolution alongside additional biomarkers to detect multiple cancers. Freenome’s development of SimpleScreen™ CRC for colorectal cancer screening and a pipeline of tests for lung cancer and additional indications is designed to increase cancer detection among millions of at-risk individuals. For more information, visit www.freenome.com.

Forward-Looking Statements

Statements we make 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 and Section 21E of the Securities Exchange Act of 1934, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are making this statement for purposes of complying with those safe harbor provisions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding SimpleScreen CRC’s impact and ability to reach additional patients; the impact of FDA approval including with respect to Medicare and ACS guidelines; Freenome’s partnership with Abbott and the expected results and benefits thereof; and Freenome’s business and strategy, including its plans with respect to its broader SimpleScreen portfolio and multiomics platform. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we 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 variety of risks and factors that are beyond our control including, without limitation, risks related to the approval of Freenome’s products and tests and the timing of expected regulatory and business milestones; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive products and tests; ability to obtain sufficient supply of materials; ability to obtain additional financing; ability to attract and retain qualified personnel; global economic and political conditions; legal and regulatory changes; the outcome of any legal proceedings that may be instituted against Freenome; the effects of competition on Freenome’s future business; as well as those set forth in Freenome’s most recent filings with the SEC, including our Form S-1. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

References

1. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. Published online June 2, 2025. doi: 10.1001/jama.2025.7515.

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– Encaleret administration increased bone turnover, based on its action to recover endogenous PTH secretion in patients with ADH1

– 100% of participants who received encaleret reported improvements in at least one ADH1 symptom compared to 46% of participants who received standard of care

– Improvements in ADH1-related impacts on daily functioning were also more frequently reported with encaleret compared to standard of care

– The FDA has accepted BridgeBio’s NDA for encaleret in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027; the Company also submitted an MAA to the EMA

– The first participant was dosed in RECLAIM-HP, the registrational Phase 3 study of encaleret in adults and adolescents with chronic hypoparathyroidism

PALO ALTO, Calif., Oct. 11, 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, today presented bone turnover results and patient-reported outcomes from the Phase 3 CALIBRATE trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1). The data were presented in oral presentations at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting in Boston, Massachusetts. Additionally, the Company dosed the first participant in RECLAIM-HP, its registrational Phase 3 study of encaleret in adults and adolescents with chronic hypoparathyroidism.

Erik Imel, M.D. of Indiana University School of Medicine, presented an oral presentation on 24-week CALIBRATE data showing that encaleret-mediated increases in parathyroid hormone (PTH) may help restore native bone physiology in ADH1. Key findings include:

• Encaleret stimulated endogenous PTH secretion to at or above the lower limit of normal in 91% of participants, compared with 0% on standard of care (SoC)
• Bone turnover markers increased in the encaleret-treated group vs conventional therapy, as assessed by markers of bone formation and resorption

“In ADH1, suppressed PTH secretion results in hypocalcemia and a tendency toward an overall reduced bone turnover state. The observed increases in bone turnover markers following encaleret administration are consistent with the effects of restored endogenous PTH secretion,” said Dr. Imel. “These findings suggest that encaleret is addressing the underlying biology of the disease, not just correcting blood calcium.”

Additionally, Steven Ing, M.D. of Ohio State University and CALIBRATE Investigator, presented an oral presentation on patient-reported outcomes demonstrating that treatment with encaleret improved ADH1 symptom burden and daily functioning compared to participants treated with standard of care (calcium supplementation and/or active vitamin D). Key findings include:

• 100% of participants who received encaleret reported improvements in at least one ADH1 symptom compared to 46% of participants who received standard of care
• Symptom improvement with encaleret treatment compared to SoC at 24 weeks included fatigue (61.3% versus 27.3%), muscle cramps (58.1% versus 36.4%), muscle spasms (58.1% versus 18.2%), tingling (51.6% versus 9.1%) and brain fog (48.4% versus 9.1%)
• Improvements in ADH1-related impacts on daily functioning were more frequently reported with encaleret compared to SoC, including mood and emotions (61.3% versus 27.3%), physical activities (45.2% versus 9.1%), daily life (35.5% versus 18.2%) and work life (35.5% versus 9.1%)

In partnership with the HypoPARAthyroidism Association (HPA), BridgeBio also shared findings in a poster from regional family genetic testing events that evaluated a proband-initiated model designed to bring no-cost genetic testing and counseling directly to at-risk relatives in their home region. Key findings include:

• 44% of participants (N=27) were symptomatic at the time of testing, and 77% of those individuals had exhibited symptoms for more than 2 years
• BridgeBio and HPA will continue to support regional family genetic testing via this model, which may offer an innovative and scalable approach to shorten the path to diagnosis for families affected by ADH1

BridgeBio also dosed the first participant in RECLAIM-HP (NCT07805356), a global, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of oral encaleret in adults and adolescents with chronic hypoparathyroidism. Approximately 160 participants will be enrolled and randomized 3:1 to receive encaleret or placebo during the 24-week double-blind treatment period. The primary endpoint is the proportion of participants achieving both blood and urine calcium within the target range at Week 24. Key secondary endpoints include reduction in and/or independence from conventional therapy, patient reported outcomes, bone mineral metabolism, and long-term safety.

“For people living with chronic hypoparathyroidism, the effects of inadequate disease control can build over time, potentially increasing the risk of kidney complications,” said Patty Keating, Executive Director of HPA. “Our community needs research that asks whether we can do better by reducing the long-term burden of managing the condition day to day. I am thrilled that the first participant was dosed in RECLAIM-HP as it is an important step toward answering that question.”

The first participant dosed in RECLAIM-HP follows a period of significant progress for the encaleret program. The FDA has accepted BridgeBio’s NDA for encaleret in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027. The Company has also submitted an MAA to the EMA for encaleret in ADH1.

In addition to the oral presentations and posters related to ADH1, BridgeBio also shared a poster featuring data showing a lack of peripheral FGFR1 inhibition at clinically relevant infigratinib exposures, supporting the safety profile observed in children with achondroplasia in the PROPEL clinical program.

About Autosomal Dominant Hypocalcemia Type 1 (ADH1)

ADH1 is a common form of genetic hypoparathyroidism caused by gain-of-function variants in the calcium-sensing receptor gene (CASR). The calcium-sensing receptor (CaSR) constantly monitors and balances blood calcium levels by regulating parathyroid hormone secretion and calcium reabsorption in the kidneys. Individuals with ADH1 typically experience hypocalcemia, hypercalciuria, and inappropriately low levels of PTH. Symptoms of hypocalcemia may include severe muscle cramps, muscle spasms (tetany), a burning or prickling sensation in the hands or feet (paresthesia), brain fog, fatigue, and seizures. Hypercalciuria may result in kidney calcification (nephrocalcinosis), kidney stones (nephrolithiasis), and kidney failure.

About Chronic Hypoparathyroidism

Chronic hypoparathyroidism is a rare endocrine condition characterized by insufficient production of parathyroid hormone (PTH), most commonly resulting from damage to or removal of the parathyroid glands during neck surgery. Insufficient PTH disrupts calcium homeostasis, resulting in hypocalcemia and a range of symptoms and complications, including muscle cramps and spasms, tingling, and fatigue. Conventional therapy consists of calcium supplements and active vitamin D and are associated with long-term complications including excess calcium excretion in the urine, kidney stones, nephrocalcinosis, and chronic kidney disease. Chronic hypoparathyroidism is estimated to affect more than 200,000 people across the U.S. and EU.

About Encaleret

Encaleret is an investigational, orally administered small molecule under investigation to treat ADH1 and chronic hypoparathyroidism that is designed to selectively negatively modulate the calcium-sensing receptor. Encaleret has been granted Fast Track Designation by the U.S. FDA and Orphan Drug Designation in the U.S., European Union, and Japan.

About BridgeBio

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 Statements

This 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, or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. 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 data regarding encaleret, including the potential for encaleret-mediated increases in endogenous PTH secretion to restore native bone physiology and address the underlying biology of ADH1, the potential for encaleret to improve ADH1-related symptoms and daily functioning, and the potential role of encaleret as an oral treatment for chronic hypoparathyroidism and its potential to regulate blood and urine calcium independently of parathyroid hormone; the design, conduct, enrollment, timing and endpoints of RECLAIM-HP, including the anticipated enrollment of approximately 160 adults and adolescents with chronic hypoparathyroidism; the potential for encaleret to reduce the burden associated with chronic hypoparathyroidism and conventional therapy; the potential long-term consequences of inadequate disease control, including an increased risk of kidney complications; and BridgeBio’s plans to continue supporting regional family genetic testing and the potential for the proband-initiated genetic testing model to provide an innovative and scalable approach to shorten the path to diagnosis for families affected by ADH1. 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 risk that results from patient-reported outcomes, exploratory analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed increases in PTH secretion and bone turnover or improvements in symptoms and daily functioning may not be replicated in additional analyses or studies or translate into meaningful long-term clinical benefits; that mechanistic interpretations regarding encaleret’s potential to restore native bone physiology, address the underlying biology of ADH1 or regulate calcium independently of parathyroid hormone may not be borne out by additional data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials, including RECLAIM-HP; that RECLAIM-HP may not enroll the anticipated number of participants or proceed according to the anticipated design or timeline; that results from prior clinical studies may not be replicated in RECLAIM-HP or other future studies; that encaleret may not demonstrate the anticipated efficacy, safety or therapeutic benefit in adults or adolescents with chronic hypoparathyroidism; that encaleret may not demonstrate the ability to normalize blood and urine calcium, reduce or eliminate conventional therapy, improve patient-reported outcomes, or favorably affect bone mineral metabolism or long-term safety; that the potential role of encaleret as an oral treatment for chronic hypoparathyroidism may not be demonstrated in further clinical development; that the anticipated long-term consequences of inadequate disease control, including kidney complications, may differ from current expectations; that BridgeBio’s plans to continue supporting regional family genetic testing may change and that the proband-initiated genetic testing model may not prove scalable or meaningfully shorten the path to diagnosis for families affected by ADH1; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine 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, Communications
[email protected]
(650) 789-8220

BridgeBio Investor Contact:

Kristen Kelleher, Director, Investor Relations
[email protected]

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