This year's European Society of Cardiology (ESC) Congress showed just how quickly cardiology is changing. Late-breaking trials, new scientific data and major guideline updates all pointed to a field that is becoming both more crowded and more complex.

A central question the conference sought to address was how effectively the two main types of ATTR-CM treatment work. Stabilizers are designed to prevent the transthyretin protein from breaking apart, while silencers reduce its production. The debate centered on whether silencers offer enough additional benefit over established stabilizers in this significant rare disease market.

One of the clearest lessons was that the challenge is no longer simply bringing more treatments to market. It is increasingly about finding the right patients earlier, understanding how different therapies compare and deciding where each option fits as standards of care improve. ATTR-CM was one of the strongest examples of that shift, with the conference data sharpening the debate over whether silencers offer enough additional benefit over established stabilizers. The same pattern could also be seen in new guidelines and in the growing role of digital monitoring.

Alnylam ($ALNY) faces new questions over Amvuttra in ATTR-CM

Alnylam Pharmaceuticals came to ESC looking to strengthen the case for Amvuttra in ATTR-CM, but the data arguably leave some important questions unanswered. While the drug is already approved, the estimated benefit appeared more modest than many investors and clinicians may have hoped, particularly given the growing expectation that newer therapies will need to demonstrate clear advantages over established treatments. The key question is whether ATTR-CM silencer treatments offer enough additional benefit on top of stabilizers that are already delivering meaningful clinical outcomes.

In light of this, there remains uncertainty around the extent of Amvuttra's value and whether it will be sufficient to secure a strong position in an increasingly competitive market. The FDA's decision earlier this year to challenge Alnylam's survival claims based on an open-label extension of HELIOS-B only adds to the need for caution. It is, therefore, perhaps unsurprising that Alnylam's share price has come under pressure and that questions are being raised about the long-term commercial viability of Amvuttra in ATTR-CM.

Rather than definitively strengthening the case for Amvuttra, Alnylam's participation at ESC suggests that important questions remain about the true scale of its advantage and whether the evidence is sufficient to establish a clear benefit over existing treatments.

AstraZeneca ($AZN) casts further doubt on silencers in ATTR-CM

In perhaps a similar spirit, AstraZeneca and Ionis used ESC to revisit the results of the Phase 3 CARDIO-TTRansform trial of Wainua (eplontersen), another potential treatment for ATTR-CM. They faced a somewhat different challenge, however, as the trial had already failed its primary endpoint, with Wainua unable to significantly reduce cardiovascular mortality and recurrent cardiovascular events in the overall study population.

The companies sought to contextualize the findings, but the presentation arguably highlighted one of the trial's central challenges. If the apparent benefit is less clear among patients already receiving stabilizer therapy, the data raise broader questions about how much additional value silencers can deliver beyond treatments that are already producing meaningful clinical outcomes. The broader question, however, is what this means for an ATTR-CM market that is becoming increasingly competitive. As new treatments emerge, should attention shift towards newer therapies, or remain focused on established stabilizers that may already be providing much of the available benefit?

New ESC guidelines and Huawei point to a prevention first approach

ESC also saw the release of new guidelines that could change how cardiovascular patients are identified and managed. The updated heart failure guidance simplifies how patients are classified and puts more focus on prevention and earlier intervention. In practice, that means clinicians may be looking for risk earlier and across a broader group of patients, rather than waiting until disease is more advanced.

That change is creating more room for digital tools. Huawei used ESC to preview its Watch D3, a wrist-based ambulatory blood pressure monitor designed to track blood pressure in everyday settings. It is one example of how wearables are moving beyond basic wellness tracking and towards data that could help identify risk earlier, monitor patients more closely and support treatment decisions.

Reflecting on ESC 2026, ATTR-CM emerged as a key area of focus. The AstraZeneca and Alnylam data raised questions about whether silencers can offer enough benefit over established stabilizers, while new guidelines and digital tools highlighted the importance of identifying risk earlier and monitoring patients more closely. The key question now, arguably, is which approaches can genuinely improve on what is already available, and which patients are most likely to benefit.

On 11 September, the Commission presented its proposal on the EU-Ecuador Sustainable Investment Facilitation Agreement (SIFA) to the Council for its signature and conclusion.  

This is the first SIFA negotiated with a Latin American country and will help promote further EU investment in Ecuador. The EU-Ecuador SIFA aims to make it easier for EU companies to invest and expand their operations in Ecuador. It benefits both EU and local investors.  

It will facilitate investment across the whole economy by supporting efforts to address challenges such as bureaucratic hurdles and regulatory uncertainty, which is especially relevant in sectors with untapped potential, such as renewable energy. For the first time in a SIFA, the agreement with Ecuador contains specific provisions which aim to deepen cooperation and facilitate investment in sustainable energy and raw materials - sectors of particular interest for EU investors and Ecuador. The SIFA is closely aligned with the EU's Global Gateway strategy in Ecuador, which supports investments and sustainable infrastructure in sectors such as energy, water sanitation, and waste management. 

The EU is a leading trade and investment partner for Ecuador, with the EU's FDI stock in the country reaching €9.1 billion in 2024. The sectors receiving the most EU foreign direct investment include construction, business services, transport, storage, communications, and manufacturing. 

Pursuing SIFAs is among the objectives set out in the EU's Competitiveness Compass, which highlighted the need to seek new ways of deepening partnerships and creating benefits for EU businesses. 

Next steps 

With its proposals for the signature and conclusion of the SIFA, the Commission is seeking the Council’s approval to sign the agreement. Once the Council gives its agreement it will be sent to the European Parliament for consent. Following approval, the deal can enter into force. 

For more information 

Commission proposals for Council decisions on the signature and conclusion of the EU-Ecuador Sustainable Investment Facilitation Agreement (SIFA) 

EU and Ecuador conclude negotiations for a SIFA  

EU-Ecuador trade relations 

On 11 September, the European Commission has put forward its proposals to the Council for the signature and conclusion of Free Trade Agreement (FTA) between the European Union and India, seeking authorization for its signature and conclusion. If authorized by the Council, this will be the largest trade agreement ever concluded by both the EU and India.

Once adopted and entered into force, the agreement will improve market access, reduce tariffs, tackle unnecessary barriers to trade, as well as provide predictable rules for trade and investment between the EU and India. The EU and India already trade over €180 billion worth of goods and services per year, supporting close to 800,000 EU jobs. This deal will eliminate or reduce tariffs on 96% of EU goods exports to India. Overall, the tariff reductions will save around €4 billion per year in duties on European products. It will make it easier for European companies to access the Indian market and compete on a more level playing field, while it will ensure consumers can benefit from increased choices and more competitive prices.

The proposal put forward today represents a key step towards ensuring that consumers and businesses can start reaping the benefits of this deal as soon as possible. This is in line with the fast-track procedure laid out by Commissioner for Trade and Economic Security, Maroš Šefčovič earlier this year. The procedure aims at speeding up the implementation of FTA's, which is crucial at a time of geopolitical uncertainty and growing pressure on the global trading system.

The EU-India FTA reflects the EU's commitment to strengthen economic ties with key partners in the Indo-Pacific region. With its proposals, the Commission is seeking Council's approval to sign the agreements which will then require European Parliament's consent, before conclusion and entry into force. The Indian authorities are in parallel going through their own internal ratification procedures.

For more information

Proposal for a Council Decision on the signing of the Free Trade Agreement between the European Union and the Republic of India

Proposal for a Council Decision on the conclusion of the Free Trade Agreement between the European Union and the Republic of India

Questions and answers on the EU-India Free Trade Agreement

Europe has plenty of world-class research, talent and creativity. However, too often ideas originating in Europe are turned into economic success by others, elsewhere. This is because European innovators face barriers here and find it difficult to bring their ideas to life. As a result, the Commission proposed a new European innovation act to help Europe's most innovative ideas be developed, financed and scaled up in Europe.

To strengthen the EU innovation system, the proposal will address two main challenges. Firstly, it will help innovative companies access financing by

• promoting a common EU framework to value intellectual property
• creating a digital marketplace connecting buyers and sellers of intellectual property
• offering expert support to help companies bring their ideas to the market

This can unlock €10.2 billion per year in additional financing and generate around €35 million in administrative cost savings.

Second, it will establish a common approach for research and development procurement that

• will provide greater legal certainty 
• help new technologies reach the market faster
• make it easier for public buyers from different EU countries to jointly carry out Research and Development procurements. 

With this, companies could expect €25.92 billion in additional annual profits, while public buyers could save €1 billion per year.

The European innovation act is an element of the competitiveness compass, to strengthen the EU's long-term competitiveness, prosperity and technological sovereignty. In parallel, the Commission will help innovators accelerate the transformation of innovative ideas into market solutions through a specific proposal on regulatory sandboxes.

For more information

Press release - Commission proposes new European Innovation Act to help innovative European ideas grow and compete globally

Questions and answers on the European Innovation Act

Factsheet on the European Innovation Act

The European Innovation Act

Hardware and software products are increasingly exposed to cyberattacks. From baby monitors and smartwatches to apps and computer programmes, products with digital elements are part of our daily lives. The Cyber Resilience Act (CRA) strengthens the cybersecurity of these products and better protects consumers and businesses from cyber threats.

As of 11 September 2026, manufacturers must report any actively exploited vulnerabilities and severe incidents that have an impact on the security of their products. They must submit an early warning within 24 hours, followed by a full notification within 72 hours. A final report must then be submitted no later than 14 days after a corrective or mitigating measure is available for an actively exploited vulnerability, and within 1 month for a severe incident. 

In practice, this means consumers can rely on faster notifications and stronger protection for their connected devices, such as door locking systems, keeping their home safe and secure in the event of a cyberattack. 

The reporting obligations apply to all products with digital elements made available in the EU, including those already on the market. Manufacturers will submit their notifications through the CRA Single Reporting Platform, established and maintained by the European Union Agency for Cybersecurity.

The Commission published practical guidance to help manufacturers, developers, and businesses meet their obligations. National market surveillance authorities will ensure enforcement of the rules. 

The Cyber Resilience Act builds on the EU cybersecurity strategy and the EU security union strategy. It aims to strengthen the EU approach to cybersecurity. The new rules require products with digital elements to be designed, updated, and maintained to protect users from security risks. The CE marking will help them identify products that comply with the CRA requirements. 

The main obligations introduced by the Act will apply from 11 December 2027, while the reporting obligations apply from 11 September 2026. 

For more information

Cyber Resilience Act

Protecting your digital life

ENISA - FAQ

Digital economy and society