- Calliditas Therapeutics AB CALT says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022.
- In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an additional list of questions related to manufacturing-related information, resulting in EMA’s opinion slipping into Q2.
- The continued review does not relate to the safety or efficacy of Nefecon, and there are no plans for an oral explanation.
- Related: Calliditas Shares Rally After FDA’s Accelerated Approval For Budesonide For Kidney Disease.
- “Targeting an opinion in Q1 was ambitious in light of the fact that this is the first time the EMA has reviewed a drug for this indication,” said CEO Renée Aguiar-Lucander.
- Price Action: CALT shares are down 5.44% at $17.90 during the market session on the last check Tuesday.
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