Acoramidis

October 9-12, 2026 | Phoenix, Arizona -- New data spans pharmacotherapy, imaging and diagnostics, and device therapy for patients with cardiomyopathy Continue Reading These trials ... represent some of the most anticipated data in ... medicine for patients with cardiomyopathy this year. Post this The HFSA Annual Scientific Meeting takes place October 9-12, 2026 in Phoenix, Arizona. WASHINGTON, Sept. 18, 2026 /PRNewswire/ -- The Heart Failure Society of America (HFSA) today announced the Late-Breaking Clinical Research slate for its Annual Scientific Meeting (ASM), October 9-12, 2026, at the Phoenix Convention Center in Phoenix, Arizona. This year's late-breaking program spans pharmacotherapy, imaging and diagnostics, and device-based therapy - including new data on whether a novel oral therapy could establish an additional treatment pillar for both HFrEF and HFpEF, a first-of-its-kind imaging approach designed to detect cardiac amyloidosis without an invasive biopsy, and real-world outcomes from established device therapies. View all late-breaking science below and online. "This year's Late-Breaking Science program reflects the pace of innovation transforming heart failure care," said Jennifer Thibodeau, MD, MSCS, 2026 HFSA Annual Scientific Meeting Program Committee Chair. "These trials showcase advances in pharmacotherapy, imaging and diagnostics, as well as device therapy, and represent some of the most anticipated data in cardiovascular medicine for patients with cardiomyopathy this year." Late-breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Sunday, October 11 Plenary Session | 9:00 AM – 10:30 AM Late-Breaking Evidence from Novel Therapies to Real-World Outcomes Cycle-1 REF A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction: The Cycle-1 REF Trial Cycle-2 PEF A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction: The Cycle-2 PEF Trial CARDIO-TTRansform Effect of Eplontersen on Health Status in Patients with Transthyretin Amyloid Cardiomyopathy Enrolled in the CARDIO-TTRansform Trial 124I-Evuzamitide Amyloid-targeted PET/CT Scan: Potential for Detection of Early Cardiac Amyloidosis in a Prospective Multicenter Phase 3 Study Cohort Cardiac Contractility Modulation Therapy One-Year Real-World Clinical Outcomes Following Cardiac Contractility Modulation Therapy from the U.S. Post-Approval Study REBALANCE The REBALANCE Registry: Real World Outcomes Following Baroreflex Activation Therapy Monday, October 12 Plenary Session | 9:00 AM – 10:30 AM Late-Breaking Evidence from Novel Therapies to Real-World Outcomes ACACIA-HCM Global Efficacy Of Aficamten In Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM Aficamten Improves Comprehensive Measures of Exercise Performance in Non-Obstructive Hypertrophic Cardiomyopathy: A Prespecified Analysis of ACACIA-HCM POSEIDON Prevalence of Cardiovascular Inflammation and Associated Patient Characteristics and Biomarker Profiles Across the Heart Failure Spectrum in the United States: Results From the POSEIDON Study C-MIC III & C-MIC II Effects of Cardiac Microcurrent Therapy on Exercise Capacity: Independent Core Laboratory CPET Analysis of the C-MIC II Trial Six-Month Outcomes of Subcutaneous Cardiac Microcurrent Therapy: Comparative Analysis of the C-MIC III Pilot Study with the C-MIC II Randomized Trial Late-breaking clinical research showcases novel results of major randomized trials and rapidly evolving research. Due to the exceptional volume and quality of research submitted this year, HFSA will also feature late-breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Sunday and Monday with Q&A and new topics each day. Sunday, October 11 | Rapid Fire 1 | 10:45 AM - 11:45 AM Ratio of Serum Transthyretin to NT-proBNP is a Novel Prognostic Measure for Transthyretin Amyloid Cardiomyopathy: Insights From ATTRibute-CM Colchicine In Patients With Heart Failure And Preserved Ejection Fraction: A Crossover Trial The ReDS-SAFE HF II: Remote Dielectric Sensing-Guided Decongestion Strategy In Patients Hospitalized For Heart Failure. A Trial Design Early eGFR Decline Following Acoramidis Initiation is Associated With Reduced Risk of Recurrent Cardiovascular Hospitalizations and Mortality Gator SCALES-WHF: Sub-Cutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure Real World Comparative Effectiveness Study of Acoramidis Versus Tafamidis in Transthyretin Amyloid Cardiomyopathy Using the Epic COSMOS Data Platform Dosing And Safety Of Aficamten For Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy In The ACACIA-HCM Trial Sunday, October 11 | Rapid Fire 2 | 2:30 PM - 3:30 PM Ambulatory Upright Pulmonary Artery Pressure and Risk of HF Hospitalization and Death in Patients with Chronic Heart Failure Hyperbaric Oxygen Therapy and EECP as Adjuvant Therapy in Heart Failure : A Prospective Interventional Study Baroreflex Activation Therapy in Heart Failure with Mildly Reduced Ejection Fraction: First Real-World Evidence of Reduced Hospitalization Burden Cost-Effectiveness Of ReDS-Guided Heart Failure Management Pulmonary Artery Pressure Response to Loop and Thiazide Diuretic Intensification in Heart Failure: Impact of Diuretic Class and Patient Characteristics Ambient Home Monitoring of Peripheral Oedema Significantly Reduces Heart Failure Events: Final Results from the Randomized HF-TRACK Trial Therapeutic Sequencing Is Projected to Improve Quality-Adjusted Survival in Heart Transplant Candidates with Advanced Heart Failure: A Risk-Selected Left Ventricular Assist Device-First Strategy Sunday, October 11 | Rapid Fire 3 | 5:00 PM - 6:00 PM Impact of Eplontersen on Cardiac Biomarkers in Participants with Transthyretin Amyloid Cardiomyopathy in the CARDIO-TTRansform Phase III Trial Weight Loss Surgery Impact on Comprehensive Metabolic Responses to Exercise in Heart Failure with Preserved Ejection Fraction Primary Results Trajectories of Dyspnea After Heart Failure Hospitalization: A Prospective Longitudinal Cohort Study Achieving Near Target-Dose Quadruple Guideline-Directed Medical Therapy Before Hospital Discharge After Acute Heart Failure: The STRONG-HF Japan Study Association of Quadruple Therapy Achievement and Biochemically Verified Medication Adherence with Outcomes in HFrEF: Insights from the POLY-HF Trial The Impact Of An Adaptive Patient-Centered Web Application on Medication Optimization In Patients With HFrEF: A Multicenter Randomized Trial Monday, October 12 | Rapid Fire 4 | 12:15 PM – 1:15 PM TAILORD Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients with Heart Failure Post-ARIES Antithrombotic Implementation and Safety Evaluation in HeartMate 3 (PRAISE HM-3) EDG-15400, A Cardiac Sarcomere Modulator, Demonstrated Favorable Pharmacokinetics, Pharmacodynamics, and Tolerability in Healthy Adult Participants Rapid Non-invasive Sensors-Derived Assessment of Left Ventricular Filling Pressure in Patients Presenting With Acute Dyspnea Three-Year Results of PROACTIVE-HF Trial Stratified by Sex The meeting kicks off in just three weeks. A full schedule-at-a-glance is available online, as well as information on the science and research available at the meeting. Learn more about the meeting and register at hfsa.org/asm2026. Media Registration & Embargo Policy Credentialed and accredited media may register for complimentary press access to HFSA ASM 2026 by contacting Laura Poko at lpoko@hfsa.org. As part of HFSA's 24-Hour Press Access Window, credentialed and accredited media will receive embargoed access to press materials beginning 24 hours before each embargo lifts. During this period, media may review embargoed press releases, abstracts, and presenter details via a secure, password-protected folder, and schedule pre-embargo interviews with late-breaking science presenters. All interviews and materials remain strictly embargoed until the time of presentation listed above. Follow #HFSA2026 for real-time coverage from the meeting. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, lpoko@hfsa.org SOURCE Heart Failure Society of America 21% more press release views with Request a Demo

iStock, Jcomp A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai. The lion’s share of medicines on the market belong to Big Pharma—drugmakers worth tens of billions of dollars—but increasingly, smaller players are braving the commercial world. “We’re seeing an explosion in the number of new product launches by biotech companies,” Graig Suvannavejh, managing director and senior biotech and biopharma analyst at Mizuho Securities, told BioSpace in an email interview. The group has documented “great successes” across the board, though the industry’s track record is by no means perfect. “Launching drugs is really hard,” he continued, especially with payers “putting in place hurdles and restrictions, making market access to new drugs more challenging.” Still, there is much to be optimistic about. Many biotechs are “preparing better” for their product launches, building up not just their commercial capacities but also their understanding of patient, physician and payer needs, Suvannavejh said. There are larger macro factors at play, too, according to Andrew Tsai, managing director at Jefferies. “Broadly speaking, we think that the improving capital markets has helped,” he told BioSpace over email. Jefferies’ analysis of the trends this year so far “suggests that 2026 financing is on pace to reach an all-time high, implying that investors have an appetite to fund assets they think may have a competitive commercial profile.” A shift in investor attitude may have also helped, Tsai said, however cautioning that he has only anecdotally observed these changes. These days, investors seem to reward companies for early sales beats of recently launched products. This is in contrast to many years ago, when “it was common for investors to ‘short the launch,’” he explained, referring to the investing tactic of actively betting on a drug failing to perform well on the market. Here, BioSpace looks at five biotechs taking the commercial plunge to find out just how favorable the current markets are to smaller companies launching a drug. Big Pharma-partnered Protagonist launches two products Protagonist Therapeutics is having a big year so far. In March, the FDA approved the Johnson & Johnson–partnered IL-23 blocker Icotyde for moderate-to-severe plaque psoriasis, unlocking a market opportunity that Truist Securities estimates could reach $5–10 billion. Then, late last month, the biotech clinched another regulatory victory for the Takeda-partnered Mimrylo for polycythemia vera. The product could hit another $2 billion in peak sales, Jefferies projected at the time. Mimrylo’s uptake is too early to assess, but Icotyde has been performing well. During J&J’s second quarter earnings call in July, CEO Joaquin Duato said that Icotyde was off to “significant early launch momentum, with uptake accelerating and performance outpacing competitors at comparable points in their launches.” While the pharma at the time didn’t provide specific sales figures for Icotyde, Jennifer Taubert, worldwide chairman of J&J’s Innovative Medicine unit, told investors that there were already more than 18,000 prescriptions of the drugs for some 11,000 patients. Psoriasis revenues for Icotyde could reach $1.6 billion by 2028, according to Visible Alpha, a division of S&P Global Market Intelligence. Protagonist and J&J continue to develop Icotyde, with an eye toward expanding to other immunology indications. The partners are running two Phase 3 studies of the drug in psoriatic arthritis, the first of which is expected to read out later this year, according to the pharma’s Q2 presentation . Approvals Takeda, Protagonist score broad FDA nod in rare blood cancer, setting up $2B opportunity The approval of rusfertide—now to be branded Mimrylo—for polycythemia vera marks a key win for Takeda, which now has crossed the FDA finish line for two of three critical product launches slated for the coming year. August 31, 2026 · 2 min read · Tristan Manalac Read more Denali Therapeutics’ Hunter syndrome launch exceeds expectations In March, Denali Therapeutics’ enzyme replacement therapy notched an FDA approval for Hunter syndrome, delivering a much-needed win for the rare disease space that at the time had been battered by a series of negative headlines. Months later, the rare disease news flow remains mixed, but Denali’s drug has continued its victory lap. The therapy, called Avlayah, made $3.6 million in its first quarter on the market, the California biotech revealed in a second quarter earnings report last month. This pleasantly surprised analysts, who had projected $1.3 million in Q2 sales for Avlayah. Given the strength of Avlayah’s first three commercial months, Denali estimates net Avlayah revenues to hit $10–12 million in the third quarter, outpacing William Blair’s original forecast of around $6 million, according to an Aug. 7 note. The firm has now bumped that up to $10.7 million in Q3 and $29.3 million for the rest of the year. What makes Avlayah’s success all the more impressive is that the drug is going up against Takeda’s Elaprase, another enzyme replacement therapy that has a two-decade headstart on the market. Denali’s launch strategy is to entice patients on Elaprase to switch over to Avlayah—an approach that William Blair calls “underappreciated.” “Denali is well positioned and capitalized to drive switches from Elaprase,” the firm wrote on Aug. 7. By the late 2030s, Avlayah sales could surpass $250 million in the U.S. and reach $1 billion worldwide. Avlayah is the first new therapy cleared for Hunter syndrome in nearly 20 years and is the first medicine that directly addresses neurologic complications of the disease, the FDA said at the time of the product’s approval. Earnings Denali climbs past Avlayah expectations with $3.6M in revenue After launching in April, Hunter syndrome drug Avlayah surprised analysts with a strong first quarter, as patients rush to get access to Denali Therapeutics’ new option. August 10, 2026 · 2 min read · Annalee Armstrong Read more BridgeBio has upper hand over ATTR adversaries BridgeBio has more than tripled sales of the transthyretin amyloidosis (ATTR) therapy Attruby in a year. Attruby revenues hit $222.4 million in the second quarter , compared with $71.5 million during the same period in 2025, the company reported last month. Analysts expect the product will continue on this upward trajectory, hitting blockbuster status this year with sales exceeding $1 billion, according to Jefferies. Attruby, a drug that stabilizes the transthyretin protein and prevents pathologic misfolding, was approved for ATTR cardiomyopathy (CM) in November 2024. This gave BridgeBio a few months lead over a crucial competitor: Alnylam’s transthyretin silencer Amvuttra, which won regulatory clearance for the treatment of ATTR-CM in March 2025 . Alnylam, however, had a leg up as a familiar brand, since Amvuttra’s first approval came in June 2022 for ATTR polyneuropathy. But with BridgeBio entering the ATTR-CM market, Amvuttra sales underwhelmed, bringing in $1.01 billion worldwide in the second quarter, below the investor consensus of $1.05 billion. Alnylam has also lowered full-year revenue guidance for Amvuttra, from $4.4 billion to $4.7 billion down to $4.2 billion to $4.5 billion. There appear to be other factors going in BridgeBio’s favor, too. In July, Attruby—alongside the broader stabilizer class more broadly—received a boost when AstraZeneca and Ionis reported a late-stage fail for their antisense oligonucleotide Wainua, which did not significantly improve cardiovascular outcomes in patients with ATTR-CM. Like Alnylam’s Amvuttra, Wainua works by lowering the expression levels of transthyretin. Attruby, on the other hand, binds to the protein and prevents a crucial step in the formation of the disease-causing clumps. “Peak sales estimates for Attruby may edge higher” after the Wainua failure, Mizuho Securities wrote in a July 9 note. Cardiovascular disease AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics. July 10, 2026 · 3 min read · Tristan Manalac Read more Axsome’s Auvelity poised for $6B peak with Alzheimer’s agitation expansion Axsome’s Auvelity first hit the market in 2022 after being approved for major depressive disorder. But in May this year, the non-antipsychotic drug won a key expansion into Alzheimer’s disease agitation—one that Jefferies’ Tsai said could position Auvelity to “capture strong [first-line] market share” in the indication. Alzheimer’s disease agitation is a largely untapped market, with the only other FDA-approved option being Otsuka and Lundbeck’s antipsychotic Rexulti , Tsai said in an email to BioSpace . Auvelity has key edge over its competition because the product doesn’t have a boxed warning flagging a heightened risk of death in older patients, he said. This safety advantage “incentivizes adoption by all parties,” Tsai said. Auvelity also doesn’t come with weight gain, anxiety and motor problems, all typical of antipsychotic medications. Following the launch in Alzheimer’s agitation in June, “we think Auvelity should reach $6B combined peak sales, split between” this indication and major depressive disorder, Tsai told BioSpace. The expansion was granted despite mixed data in January 2025 that showed no significant advantage to Auvelity over placebo in terms of agitation scores, the primary endpoint of the late-stage ADVANCE trial. But the drug met its primary endpoint of lowering relapse risk in the Phase 3 ACCORD-2 study. Approvals Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair. May 1, 2026 · 2 min read · Tristan Manalac Read more Despite patent hump, Ascendis continues achondroplasia ascent The FDA signed off on Ascendis’ Yuviwel in March, but months earlier, in October 2025, BioMarin had already started bracing for impact. BioMarin markets Voxzogo, which was approved for achondroplasia in November 2021 and for years reigned as the only therapy for the disease on the market. With competitive pressures on Voxzogo’s horizon—from Yuviwel and other achondroplasia products in development—BioMarin in October abandoned a goal of hitting $4 billion in revenue in 2027. So far, Yuviwel seems to be living up to investors’ high expectations. In the second quarter, Ascendis reported €8 million ($9.3 million) in sales for Yuviwel, which as of July 31 had reached 220 patients in the U.S. since the April launch. “Early uptake is strong,” H.C. Wainwright wrote on Aug. 27. “Voxzogo built a blockbuster market that Yuviwel only needs to convert,” the firm added. This could prove to be a relatively simple task for Ascendis, given Yuviwel’s convenience edge. While Voxzogo is given daily , Yuviwel is a weekly injection . “Yuviwel has a stronger competitive pro Voxzogo,” Leerink Partners said in an Aug. 18 note. “Weekly-versus-daily is a genuine convenience edge over BioMarin.” Last month, however, BioMarin was able to eke out a victory against Ascendis in a settlement agreement that gives BioMarin 18% to 20% royalties on net Yuviwel sales through May 20, 2030. BioMarin in early 2025 filed a complaint alleging that Ascendis infringed on a European patent for Voxzogo. The settlement will allow BioMarin to “participate economically in Yuviwel’s commercial success,” William Blair wrote on Aug. 31, but the market is still likely to shift in Ascendis’ favor. Rare Diseases Ascendis Readies BioMarin Challenge in Achondroplasia While Others Search for Root Cause Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease. October 13, 2025 · 7 min read · Tristan Manalac Read more