*|MC_PREVIEW_TEXT|*

Silencers vs. Stabilizers in ATTR-CM, Cardiologist Comp, and Regulatory News
By Viktor Zarev, Jack Troy, Virginia Hunt, Jason Barry
July 13, 2026
site logo

Together with

partner logo

“Nothing says ‘we value your contribution to science’ quite like asking uncompensated reviewers to improve a paper so we can charge the authors thousands of dollars to publish it.”

Brett Sperry, MD.

It’s never fun for pharma companies when their drug trial fails. On the bright side, sometimes we learn more that way.

Come check it out,

Vik

Pharmaceuticals

CARDIO-TTRansform and The Future of ATTR-CM Drugs

The ATTR-CM drug race almost got another contender, but AstraZeneca and Ionis’ Wainua unexpected Phase 3 trial failure might have actually simplified the field.

  • Wainua earned FDA approval in 2023 for ATTR-polyneuropathy, bringing in $212M in 2025, with Ionis collecting $49M in royalties.
  • It belongs to the TTR silencer drug class, which is already known to be effective in ATTR-CM, so the trial was widely expected to succeed.

Initially intended to support FDA approval, the Phase 3 CARDIO-TTRansform study enrolled 1,432 patients and randomized them to Wainua or placebo plus standard of care, with results showing that…

  • The trial missed its primary endpoint of reducing cardiovascular deaths or repeat CV events over a 140 week follow-up.
  • Most patients were also receiving a stabilizer drug (57% at baseline in each arm, with another 24% adding one during the trial).
  • One patient subgroup was assigned to Wainua as a monotherapy and saw a 29% risk reduction, so it’s worth noting the therapy still worked to an extent.

The most likely culprit for these results is how ATTR-CM treatment is evolving rather than an ineffective drug.

  • According to Ionis, the data speaks to how effective ATTR stabilizers have become, making the add-on benefits of Wainua hard to demonstrate.
  • That said, Alnylam’s HELIOS-B trial, which tested the silencer-plus-stabilizer combo did show benefit, so there is a question as to why Wainua couldn’t replicate that.

Two other players stand to gain. BridgeBio’s stabilizer Attruby, which binds TTR rather than silencing it, looks emboldened, as does Intellia’s one-time CRISPR gene therapy nex-z, developed with Regeneron.

  • With Wainua out of the running, Attruby’s sales are also likely to climb (it brought in $362.4M in 2025).

But these Phase 3 results also cut against Alnylam’s next-generation bet. The company is already developing nucresiran (a silencer like Wainua) with the TRITON-CM trial expected to read out in 2030.

  • The Wainua miss now raises questions about whether a next-gen silencer can prove itself in a stabilizer-dominated market.

And of course, it wouldn’t be cardio-pharma news without a mention of AZ and Ionis’ stock.

  • Ionis shares fell around 20% and AstraZeneca dropped 7%, while rivals Alnylam and BridgeBio rose roughly 10% and 15% respectively.
  • The failure leaves Alnylam’s Amvuttra as the only approved TTR silencer for ATTR-CM.

The Takeaway

While the CARDIO-TTRansform trial isn’t a win for Astrazeneca/Ionis’ Waiuna, it helps clarify where the real effective therapy for ATTR-CM stems from. For now, this trial’s results point to TTR stabilizers rather than silencers as the way to go

The Economics of AI-Assisted HF Diagnosis

As sonographer shortages become more common, so too are diagnostic delays and missed opportunities for early heart failure treatment. Find out how task-shifting LVEF assessment to novice operators using AI-assisted ultrasound is both clinically viable and cost-saving.

sponsor logo

Changes in Heart Failure Management

Heart failure is a complex condition with high heart failure hospitalization and cardiovascular mortality rates, especially among patients with HFpEF and HFmrEF, for whom treatment options have been limited. Read how Bayer’s Dr. Alanna Morris-Simon discusses the changing treatment landscape and strategies for improving patient outcomes.

sponsor logo

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

sponsor logo

The Wire

  • Bayer’s First Academic Trial Alliance: Bayer announced a first-of-its-kind clinical trials alliance with the University of Colorado Anschutz, UCHealth, and Children’s Hospital Colorado. The partnership aims to improve trial efficiency and investigational therapy access within oncology, cardiovascular disease, chronic kidney disease, and beyond. By pairing Bayer’s drug development infrastructure with the academic and clinical strengths of the Colorado partners, the collaboration seeks to expand trial infrastructure, accelerate launch times, and facilitate earlier, broader patient enrollment.
  • Cardiologist Pay Keeps Climbing: An American Medical Group Association survey found that cardiologist compensation continues to rise, with considerable variation by subspecialty. Overall comp grew 4.3%, with electrophysiologists (+8.4% to $831k) and echo/imaging cardiologists (+18.6% to $728k) seeing the biggest jumps. Advanced HF and transplant cardiologists saw a pay dip, slipping 2.6% to $562k alongside a steep 19.7% drop in work RVUs. Notably, much of cardiologists’ compensation growth stems from rising wRVU production, which can’t climb forever if reimbursement stagnates.
  • Cash for a Hybrid Imaging Clearance: Canada-based Conavi Medical received a $1.25M payment from the Province of Ontario for securing FDA 510(k) clearance of its dual-registered Novasight Hybrid System IVUS-OCT imaging system. The dual modality system is the first to co-register and co-align intravascular ultrasound and optical coherence tomography  imaging for coronary arteries. Conavi says the funding will support commercialization as it expands its U.S. presence.
  • Powering a Turnkey Cardiac Monitor: AccurKardia and Wellysis signed a multi-year agreement under which AccurKardia’s AccurECG 2.0 will power the analytics behind Wellysis’ turnkey cardiac monitoring offering in the United States. The deal pairs Wellysis’ S-Patch wearable ECG monitor with AccurKardia’s automated ECG analytics and reporting platform for RPM via Holter, extended Holter, and mobile cardiac telemetry workflows. This further builds on the companies’ prior collaboration, having integrated their platforms in April 2025 before AccurKardia became an approved Wellysis vendor that June.
  • Putting a Price Tag on AI: CMS proposed stopgap changes to Medicare payments for AI-powered software. The agency has long weighed how to reimburse services whose value comes not from tangible inputs, like labor and supplies, but an algorithm that produces a diagnosis or treatment recommendation. The plan is characteristically modest: Rename the SaaS category to “Software as Medical Service,” move 36 codes there, and assign temporary rates to 21 of them. It nonetheless signals a shift in how CMS views some of the hottest technologies in healthcare. 
  • U.S. Heart & Vascular’s Georgia Expansion: USHV partnered with two leading Georgia heart clinics to expand the private equity-backed mega practice  into a sixth state. This acquisition will add Cardiology of Atlanta and Cardiovascular Clinic of North Georgia to its network of over 15 practices employing >200 specialists. USHV believes this move will improve community cardiac care by increasing the availability of advanced tech, like cardiac PET and CT imaging.
  • Healthcare Spending Soars: CMS found that U.S. healthcare spending rose 7.3% last year to $5.7T, continuing the trend seen in 2023 and 2024. The surge stems from sky-high care utilization and drug spending, especially on GLP-1s. The report anticipates a slowdown throughout 2026, with declining ACA and Medicaid enrollment throwing a wet towel on the spending frenzy. Americans are nonetheless pacing $9T in healthcare spending by 2034, outstripping GDP growth and making the sector even more central to the U.S. economy.
  • Breakthrough Device Misnomer: STAT’s freshly updated Breakthrough Device Tracker shows that most “breakthrough” devices haven’t exactly managed to live up to the name. Only 198 of the nearly 1,300 devices have gone on to be authorized, and most of the remaining solutions have been sitting off the market for over four years. Note that the FDA’s breakthrough designation was designed to expedite regulatory review for devices that could eventually prove to be “more effective” at treating or diagnosing deadly conditions, but it has no bearing on whether a device will get authorized or prove more effective than alternatives.
  • HCM’s Mild Phenotypes & Major Risks: A new JACC study reported that one in five patients with phenotypically mild HCM will have a major adverse cardiac event. Current management focuses on improving symptoms, but researchers note that disease-modifying treatments may be superior as they have the potential to remodel the left ventricle to a healthy state. The study also found that factors such as older age and symptom onset may increase risk of MACE.
  • Cardiac Dimensions’ Triple Pub Triumph: Cardiac Dimensions announced a trio of publications highlighting the efficacy, versatility, and durability of its Carillon transcatheter for mitral regurgitation. The first study found 97% of patients had stable/improved MR staging after five-years, and nearly half were free from HF hospitalizations. The second paper reported improved BNP levels, left atrial size, and diastolic filling pressures for communities commonly underrepresented in trials. Lastly, the third paper supported the device’s durability with a cardiovascular survival rate of 66% after 10 years.
  • Finding the Rhythm in Cardiac Rehabilitation: A European Journal of Preventive Cardiology paper suggests harmonica-based breathing may not help boost heart health, at least in the short run. The trial included 80 individuals with CAD/HF who were assigned to telerehabilitation programs either with or without added harmonica exercises. The groups didn’t differ significantly in oxygen uptake or mobility improvement after a month, and the harmonica-based group (48.7%) were much less likely than controls (73.2%) to stick to the regimen.

Redefining Cardiac Analytics

More data doesn’t equal deeper insight. There’s a fundamental difference between measuring the timing of heart beats and understanding how the heart recovers electrically after each beat. Monebo is using that distinction to define the next frontier of cardiac analytics.

sponsor logo

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

sponsor logo

From Fetal to Adult Cardiovascular Ultrasound

Continuity of care is critical when it comes to a patient’s cardiovascular health. That’s why cardiologists across America are picking Fujifilm’s Lisendo 880 cardiovascular ultrasound for its versatility and precise imaging starting at a patient’s fetal development to adulthood.

sponsor logo

The Resource Wire

  • State-of-the-Art Cardiac Monitoring at Scale: Cleared for 13 different heart rhythm interpretations, AccurKardia’s AccurECG 2.0 shortens the time from an arrhythmia incident to clinical intervention. Watch here to find out how AccurKardia and Specialized Medical are teaming up to bring the AccurECG 2.0 technology to clinicians across the U.S. 
  • How AI Expands the Role of CMR Experts: If you’re an MRI technologist, AI could be the best thing that ever happened to your career. Read here to learn about the benefits of AI for CMR experts and how it can accelerate both your training and career.
  • ALL‑RISE Trial Results Are In: The CathWorks FFRangio™ system met noninferiority to wire-based physiology for MACE at one year with statistically significant improvement in resource utilization and reduced procedure time. CathWorks FFRangio™ system is the new standard in coronary physiology. See the ALL-RISE data. The information provided by the CathWorks FFRangio™ system is intended to be used by a qualified clinician in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation. Source: Fearon et al. NEJM 2026. doi: 10.1056/NEJMoa2600949
  • 9 Merge Cardio Features to Change Your Cardiology Workflows: Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.
  • The Power of AI in Cardiovascular Imaging: Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from ACUSON Origin customer, Tony Gallagher about how Siemens Healthineers’ cardiovascular ultrasound system is improving exam efficiency and showing positive impact on ROI.
  • cvi42’s Real World Results: Consistency of measurements over time is of utmost importance for clinical interpretation and follow-up. Read about how cardiac imagers are using Circle Cardiovascular Imaging’s cvi42 platform to dramatically reduce manual segmentation by up to 60%.

The Industry Wire

  1. Mayo Clinic exec files retaliation lawsuit after raising AI oversight concerns.
  2. HIPAA Security Rule overhaul delayed to mid-2027.
  3. Who’s going to run the FDA?
  4. Tampa General kicks off legal fight over Lilly’s 340B restrictions.
  5. Private equity may skirt oversight with nonprofit healthcare joint ventures.
  6. Strikes boil at Mass General Brigham, Mount Nittany.
  7. Trump grant overhaul draws pushback.
  8. CEO of pandemic-era pill mill Done sentenced to six years in prison.
  9. Audit of UnitedHealth home visits finds most diagnoses supported by data.
  10. Epic to expand 4 leaders’ roles after Sumit Rana exits.