In premarket trading, Calliditas Therapeutics AB (NASDAQ: CALT) was up 5.96% to trade for $28.59 at the last check. The Calliditas stock closed yesterday’s trading in a near-stable range, up 1.2% to $26.99.
In the current quarter, the average volume of CALT stock has been 36.79K shares, while the volume of 90,650 shares in the last trading was higher. In the regular trading session, the CALT stock price oscillated between $26.75 and $27.38. This morning rise in CALT stock follows an accelerated review of its lead product in Europe.
What was the accelerated assessment granted for?
Calliditas Therapeutics is a biopharmaceutical company based in Stockholm, Sweden. CALT aims to identify new treatments that treat orphan diseases, in particular kidney and liver disorders that have important unmet medical needs. IgA nephropathy, or IgAN, is a highly unmet medical need for which there are no approved treatments, and for which Calliditas’ lead product candidate, Nefecon is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant.
The European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has granted accelerated assessment procedures for Nefecon, Calliditas’ lead product candidate.
A marketing authorization application (MAA) is reviewed faster by the EMA when using an accelerated assessment method. Typically, a complex MAA assessment may take 210 procedure days; however, with accelerated assessment, the maximum time frame can be cut to 150 days.
CALT’s MAA plan:
It is expected that Calliditas (CALT) will submit a marketing authorization application for Nefecon to the EMA in Q2 2021. If approved, CALT’s Nefecon could be on the market in Europe in H1 2022 and will be the first treatment specifically designed and approved for IgAN and possibly the first to have the potential to better medical conditions.