AstraZeneca shares fall after Wainua trial misses heart death goal
AstraZeneca faces fresh pressure in its drug pipeline after a late-stage study of Wainua fails to achieve its main objective in heart disease. The setback hits the UK drugmaker weeks after a U.S. regulatory delay for a separate cancer treatment and sends its shares down 9 per cent in early London trading.
Highlights
- AstraZeneca shares fall after phase 3 trial shows Wainua fails to achieve statistically significant reduction in cardiovascular-related deaths.
- The Wainua trial miss, announced Thursday, marks a second recent pipeline setback following the May U.S. regulator delay on a new cancer treatment approval.
- Despite 16 positive late-stage results in 2023, including Datroway and baxdrostat, investor sentiment weakens due to pipeline execution concerns after the Wainua disappointment.
Late-stage trial outcome and company response
As reported by Financial Times, AstraZeneca said on Thursday that its heart disease drug Wainua fails to meet targets in a phase 3 trial, including the goal of reducing cardiovascular-related deaths. The company says the treatment, developed with U.S. company Ionis, does not provide a statistically significant benefit on that measure.Wainua is designed to treat transthyretin-mediated amyloid cardiomyopathy, a condition caused by a build-up of proteins in the heart. AstraZeneca says the disease affects an estimated 300,000 to 500,000 people globally.
Sharon Barr, executive vice-president for biopharmaceuticals research and development at AstraZeneca, says that although the trial does not meet its primary objective, the results support greater scientific understanding of treatment approaches for patients with the progressive and often fatal condition.
Pipeline pressure and market impact
The trial result marks a second recent setback for AstraZeneca after U.S. regulators in May delay approval of a new cancer treatment. The latest disappointment adds to investor concern over execution in parts of the company’s development pipeline.Even so, AstraZeneca reported 16 positive late-stage trial results last year, including outcomes for breast cancer drug Datroway and baxdrostat for blood pressure. That broader record provides some support for the group, but the Wainua result weighs on sentiment in the near term.
Our earlier coverage of Vertex Pharmaceuticals’ $10 billion all-cash acquisition of Crinetics explained how the deal broadened Vertex’s portfolio with an approved drug (Palsonify) and a pipeline candidate (Atumelant). We also noted that the market response reflected near-term uncertainty about the size of the cash outlay, with VRTX trading under key moving averages as investors weighed strategic pipeline expansion against execution and integration risks.
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