AstraZeneca rally continues as US regulator endorses cancer drug
AstraZeneca’s share price rally continued this morning on news that its leading immuno-oncology drug Imfinzi has been granted ‘breakthrough’ status by US regulators, despite a major setback in its long-awaited ‘Mystic’ clinical trial last week that wiped £10bn from its market value. The Food and Drug Administration (FDA) decision means that Imfinzi will be reviewed more quickly for treatments relating to previously treated non-metastatic lung cancer. This means it could potentially be launched more quickly. An AstraZeneca trial called Pacific, which reported in May, found patients with this kind of cancer were responsive to Imfinzi. The cause of the company’s share price crash last Thursday stemmed from a negative result from Mystic, a separate trial of Imfinzi that targeted the larger, advanced lung cancer market. AstraZeneca share price AstraZeneca shares dived 16pc on the Mystic results to below £43, down from the previous day’s close of £51, their biggest single day fall. But they rallied slightly on Friday and continued to claw back some of their losses today on the FDA news, edging up more than 2pc in early afternoon trading to just shy of the £46 mark. However, in more negative news, ratings agency Moody's followed Standard & Poor's lead from last Friday and downgraded AstraZeneca's borrowing a notch to A3- as a result of the Mystic readout. Standard & Poor's had reduced its rating to BBB+. Sean Bohen, chief medical officer at AstraZeneca, said: "For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. “Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Timeline | Cancer breakthoughs “Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, non-metastatic setting, so following the Breakthrough designation we hope to bring it to patients as soon as possible." AstraZeneca said last week it believes Imfinzi - which is already approved for use in some bladder cancer patients - still has the potential to be a blockbuster earner for the company. It remains hopeful of a positive overall result from the Mystic trial, expected in the first half of next year, but analysts are less optimistic about its potential and have questioned whether chief executive Pascal Soriot has the right strategy to rapidly increase sales.