Calliditas says EMA process for Nefecon delayed

Swedish biopharma Calliditas Therapeutics (Nasdaq Stockholm: CALTX) saw its shares fall almost 6% to 84.90 kronor today, after it announced that there would be a delay in the European approval of its new oral formulation of budesonide, being developed under the project name Nefecon.

The European Medicines Agency has said the opinion of its Committee for Medicinal Product for Human Use (CHMP) cannot be expected until the second quarter of 2022 because it has further questions.

In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed Calliditas that it will issue an additional list of questions related to manufacturing related information which will result in the opinion from EMA slipping into the second quarter. The continued review does not relate to the safety or efficacy of Nefecon, and there are no plans for an oral explanation.