- Calliditas Therapeutics AB (NASDAQ: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.
