Sanofi backs down, recruitment of tolebrutinib trials suspended

PARIS, Aug 9 (Reuters) – Sanofi fell on the stock market on Tuesday morning after announcing the end of recruitment for clinical trials of tolebrutinib, an experimental treatment for certain forms of multiple sclerosis and myasthenia gravis.

The title of the French pharmaceutical group lost 1.37% to 95.52 euros, the largest drop in the CAC 40 index, then down 0.12%.

In a statement released on Monday after the US markets closed, Sanofi explains that the independent data monitoring committee (iDMC) responsible for overseeing clinical trials of tolebrutinib has requested that the recruitment of all these trials be suspended, without specifying the reason for this. interruption.

He stresses, however, that he continues to investigate the impact of tolebrutinib on the functioning of the liver in the patients concerned.

At the end of June, the American Food and Drug Administration (FDA) had already requested a partial suspension of trials in the United States after several cases of liver damage linked to exposure to the molecule.

iDMC’s recommendation “adds to the uncertainty over the drug’s approval,” notes JPMorgan.

Sanofi is also suffering from the lowering of UBS’s recommendation to “neutral” against “buy”, with a price target reduced from 118 to 103 euros.

The Swiss bank justifies its decision by the prospect of a slowdown in growth and increased research and development expenditure, citing among other things the difficulties of amcenestrant, a treatment for breast cancer, and those of tolebrutinib.

Its analysts have also reduced their estimate of the peak sales of tolebrutinib from two billion to one billion euros.

(Written by Marc Angrandn Edited by Kate Entringer)