AstraZeneca: AZD5462 Heart Failure Data, CARES Miss, Imfinzi Approval, Shore Downgrade

AstraZeneca presented positive early-phase data for its investigational heart failure drug AZD5462 at ESC Congress 2026, while the global CARES Phase III programme with anselamimab failed to meet its primary endpoint and the FDA approved Imfinzi for a bladder cancer indication. Separately, Shore Capital downgraded AstraZeneca to 'hold' from 'buy', citing a less favourable earnings trajectory as the drugmaker prioritises revenue growth through escalating research spending.

New clinical data presented at ESC Congress 2026 showed that AZD5462, an investigational oral relaxin agonist, improved cardiac function in patients with chronic heart failure compared with placebo in an early phase trial. The late-breaking results, highlighted in a Hot Line session at ESC Congress 2026 in Munich and published in a leading cardiology journal, reported improvements in key measures of cardiac function and a low incidence of adverse events. According to the ESC Congress 2026 press release, the incidence of adverse events was low, with no excess of adverse events in patients receiving AZD5462 compared with those on placebo. Mild reductions in blood pressure were observed but without a higher rate of significant hypotension versus placebo. The study is an early phase trial and does not yet provide large-scale outcome data.

AstraZeneca reported on May 29 that the global CARES Phase III clinical programme showed that treatment with anselamimab led to 'nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain (AL) amyloidosis as first-line therapy added to standard of care plasma cell dyscrasia (PCD) treatments, compared to placebo'. Anselamimab is a potential first-in-class anti-fibril therapy. In the overall population of patients with AL amyloidosis, treatment with anselamimab did not meet the primary endpoint, defined as 'a hierarchical combination of time to all-cause mortality (ACM) and frequency of cardiovascular hospitalisations (CVH), as previously disclosed'.

In a separate development, AstraZeneca reported on May 28 that Imfinzi (durvalumab), in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, received approval by the FDA in the U.S. to treat adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). The FDA's approval is based on positive results from the POTOMAC Phase III trial.

Shore Capital downgraded AstraZeneca to 'hold' from 'buy'. The shares trade at 20 times forecast 2026 earnings, and AstraZeneca has an $80 billion 2030 revenue target. The pharmaceutical group delivered 16 positive clinical readouts in 2025, collectively expected to generate more than $10 billion in peak year revenues, and a further 20 readouts anticipated in 2026 carry similar value. Near-term earnings progression has slowed to 10% compound annual growth between 2025 and 2028 as R&D investment surges. Shares trade ahead of both peer group multiples and historical averages. On February 13, 2026, shares were up 11% year-to-date at 15,068p, up 1% on the day.