HC Andersen Capital Events 22.09.22: Meet the top management in InDex Pharmaceuticals

HC Andersen Capital are hosting a digital event where you can meet and ask questions directly to the top management. It is free for all to attend.

InDex Pharmaceuticals - Positive feedback form Japanese authorities (PDMA) for Cobitolimod
Meet and ask questions to Acting CEO Johan Gileus from InDex Pharmaceuticals and CMO Anders Bröjersen who will update us on the announcement regarding Cobitolimod in Japan.

The phase 3 program – Conclude, consists of two sequential global induction studies and a year-long maintenance study. The first phase 3 study of Conclude is ongoing and results are expected during H2 2023. The second phase 3 study of Conclude is expected to start after a positive read-out of the first study.

PDMA didn’t require additional studies prior to including Japanese patients in the global phase III study. In addition, the PMDA stated overall acceptance for the non-clinical package as well as the study design of the phase III program.

Pharmacokinetic data for cobitolimod in Japanese patients will have to be collected before applying for market approval but can be conducted during the remaining phase III program. This is a unique decision by PDMA and indicates a great potential for Cobitolimod in Japan.

Thursday 22th of September 10:00 - 10:30

Sign up free via. link


Disclaimer: HC Andersen Capital receives payment from the company mentioned for a DigitalIR/Corporate Visibility agreement. The content is not buy or sell recommendations.

Mie Halse
Head of Digital and Events
mie@hcandersencapital.dk
+45 28746640
 

#DigitalIR is the digitalization of the relationship between investors and stock-listed companies. #DemocraticIR is the basic idea that all investors should have access to equal information.