Pharmaceutical

Abivax halts fall in Paris after 2 June meltdown

Obefazimod exceeded efficacy expectations for inflammatory bowel disease, but tumours were found in some patients given it

by Martina Soligo

 Premreuthai - stock.adobe.com

2' min read

Translated by AI
Versione italiana

2' min read

Translated by AI
Versione italiana

(Il Sole 24 Ore Radiocor) - The fall finally stopped. Abivax closed the 3 June session at EUR 71.25 per share, up 5 percentage points. In the morning, however, the company had continued to fall on the Paris Stock Exchange after plunging more than 46% on the eve of the session on Tuesday, 2 June. Driving the share price down were the results of a clinical study on an experimental drug for inflammatory bowel disease, which reported cases of cancer.

In detail, the group announced that the drug Obefazimod has exceeded efficacy expectations at a late stage of the clinical trial.

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Patients experienced clinical remission rates of around 40 per cent with two different dosages, once corrected for the placebo effect. "This result is significantly higher than our expectations, which were around 30%, and compares favourably with existing therapies, which typically show placebo-adjusted remission rates between 19% for Stelara and 32% for Velsipity," says analyst Damien Choplain of Stifel in a note.

However, Abivax also reported cases of cancer in several patients treated with the drug and one case in a patient who had received placebo.

Abivax stated that the independent monitoring committee and the doctors in charge of the study did not identify any causal relationship between the drug and the tumours observed during the trial.

The company expects to file for approval with US regulators by the end of the year. According to Jefferies, even if the tumours were unrelated to the treatment, it would increase the risk of a more complex regulatory pathway towards approval of the drug, while according to Stifel, approval of the drug appears likely, provided the full data does not confirm a causal link between the treatment and the observed adverse events.

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