Brief: Egetis Submits Marketing Authorisation Application For Emcitate To EMA

Egetis Therapeutics AB (publ)

09/10/2023 06:07

Oct 9 (Reuters) - Egetis Therapeutics AB (publ)
 EGTX.ST :
    * EGETIS SUBMITS MARKETING AUTHORISATION APPLICATION FOR
EMCITATE
FOR TREATMENT OF MCT8 DEFICIENCY TO EUROPEAN MEDICINES AGENCY
    * TOPLINE RESULTS ARE EXPECTED DURING FIRST HALF OF 2024
    * EGETIS INTENDS TO SUBMIT NEW DRUG APPLICATION (NDA) IN USA
FOR
EMCITATE IN MID-2024 UNDER FAST-TRACK DESIGNATION GRANTED BY FDA
    * MAA SUBMISSION IS BASED ON RESULTS FROM TRIAC TRIAL I,
WHICH
SHOWED STATISTICALLY SIGNIFICANT AND CLINICALLY RELEVANT
TREATMENT EFFECTS ON KEY ASPECTS OF DISEASE

Source text for Eikon:  ID:nMFN7g770j 
Further company coverage:  EGTX.ST 

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