Amgen's VESALIUS-CV Trial Success and Its Impact on the Cardiovascular Therapeutics Market

Amgen's landmark VESALIUS-CV trial has redefined the landscape of cardiovascular therapeutics, delivering a resounding validation of Repatha (evolocumab) as a transformative therapy for primary prevention. The Phase 3 trial, involving over 12,000 high-risk patients without prior cardiovascular events, demonstrated statistically and clinically significant reductions in major adverse cardiovascular events (MACE), including coronary heart disease (CHD) death, myocardial infarction (MI), and ischemic stroke, according to an Amgen press release. These results, achieved while patients were already on optimized lipid-lowering therapies, underscore Repatha's potential to address unmet needs in lipid management and expand its market reach to tens of millions of patients previously ineligible for PCSK9 inhibitors, according to a Benzinga analysis.

Market Leadership and Competitive Dynamics

Amgen's success in VESALIUS-CV positions Repatha as the first and only PCSK9 inhibitor proven effective in both primary and secondary prevention settings, per the Amgen press release. This dual validation strengthens Amgen's leadership in a market projected to grow at a compound annual growth rate (CAGR) of 19.64%, reaching $7.71 billion by 2030, according to a Mordor Intelligence report. However, the company faces a complex competitive environment. Novo Nordisk's inclisiran, a siRNA-based PCSK9 inhibitor requiring biannual dosing, has emerged as a disruptive force, leveraging convenience to capture market share. Meanwhile, Amgen's earlier patent disputes-culminating in a 2025 Supreme Court ruling that invalidated its broad PCSK9 patents-have opened the door for biosimilars and alternatives like Sanofi/Regeneron's Praluent, as noted in the Amgen release.

Despite these challenges, Amgen's strategic initiatives, including partnerships to improve LDL-C testing and public-private collaborations aimed at reducing U.S. cardiovascular events by 50% by 2030, reinforce its long-term vision, as highlighted in the Benzinga analysis. These efforts align with a broader industry shift toward early intervention, where Repatha's ability to lower LDL cholesterol by up to 60% offers a compelling value proposition described in the Amgen press release.

Investment Implications and Analyst Outlook

The VESALIUS-CV results have already catalyzed a surge in Amgen's stock, which hit $296.93 on October 2, 2025, following the FDA's expanded approval of Repatha, as reported in a MarketMinute article. Analysts have responded with a cautiously optimistic outlook, with an average 12-month price target of $308.25 (a 2.03% increase from prior estimates), according to the Benzinga analysis. While some institutions, like Piper Sandler, have upgraded their rating to "Overweight" with a $342.00 target, others, including B of A Securities, maintain a "Underperform" stance at $272.00 - a divergence that reflects differing views on biosimilar erosion risks versus the drug's expanded label and Amgen's robust pipeline, including Imdelltra and Tezspire.

Institutional investors have also shown mixed signals. Wellington Management Group reduced its stake by 12.4%, while Vanguard Group and Northern Trust increased holdings, signaling a spectrum of confidence in Amgen's ability to navigate competitive pressures, as summarized in the Benzinga analysis. Financial metrics further support a bullish case: Amgen reported 9% year-over-year revenue growth and 21% non-GAAP earnings per share growth in Q3 2025, driven by Repatha's expanded indications and cost-cutting measures, according to the MarketMinute article.

Long-Term Prospects and Innovation Risks

The cardiovascular therapeutics market is poised for disruption as oral PCSK9 inhibitors (e.g., Merck's MK-0616) and gene-based therapies enter late-stage trials, a dynamic noted in the Amgen press release. These innovations threaten to commoditize injectable PCSK9 inhibitors like Repatha, though Amgen's first-mover advantage and strong clinical data may insulate it from immediate erosion. Additionally, Novo Nordisk's foray into cardiovascular care via inclisiran highlights the sector's attractiveness, with RNAi therapies projected to capture 15–20% of the PCSK9 market by 2030, per the Mordor Intelligence report.

For investors, the key question is whether Amgen can sustain its leadership amid these headwinds. The company's recent focus on implementation science-such as improving post-PCI patient adherence to PCSK9 therapy, discussed in a Trial Designs paper-suggests a commitment to addressing real-world barriers. However, the looming biosimilar threat by 2030 and the rise of oral alternatives could cap Repatha's peak sales growth, currently at $2.2 billion annually, as reported in the MarketMinute article.

Conclusion

Amgen's VESALIUS-CV trial represents a watershed moment for cardiovascular therapeutics, validating Repatha's role in primary prevention and expanding its market potential. While the company's patent challenges and competitive pressures are real, its clinical leadership, strategic partnerships, and financial resilience position it as a resilient long-term investment. For biotech investors, the trial underscores the importance of balancing innovation risks with the transformative potential of therapies like Repatha-a drug that could redefine cardiovascular care for decades to come.