Sept 27 (Reuters) - SENSORION SA ALSEN.PA :
* SENSORION REPORTS 2021 FIRST HALF RESULTS
* SENS-401 TRIAL PROTOCOL FOR SSNHL SUCCESSFULLY AMENDED,
CLINICAL
TRIAL APPLICATION FILING IN CIO IN ADULTS CONFIRMED FOR H2 2021
* PLANS TO FILE CLINICAL TRIAL APPLICATION (CTA) IN H1 2023
FOR
OTOF-GT
* LAUNCH OF A THIRD GT PROGRAM TARGETING GJB2-GT FOR ADULT
AND
PEDIATRIC SEGMENTS
* CASH POSITION OF C.EUR 55M AT JUNE 30, 2021 PROVIDES
UNCHANGED
RUNWAY UNTIL END OF H2 2022
* OTOF-GT GENE THERAPY PROGRAM: CLEAR ADVICE FROM EUROPEAN
MEDICINES AGENCY TO PROGRESS PROGRAM
* THIRD COLLABORATION WITH INSTITUT PASTEUR: GJB2 GENE
THERAPY
TARGETING ADULT AND PEDIATRIC SEGMENTS
* IN Q3 2021, SENSORION RECEIVED CLEAR FEEDBACK FROM EMA'S
ADVISORS ON OVERALL DEVELOPMENT PLAN FOR OTOF-GT
* NATURAL HISTORY STUDY WILL ENABLE SENSORION TO SELECT MOST
RELEVANT AND CLINICALLY MEANINGFUL ENDPOINTS AND CLINICAL TRIAL
DESIGN AS OTOF-GT PROGRESSES INTO CLINIC
* EXPECTS TO FILE A CLINICAL TRIAL APPLICATION (CTA) FOR ITS
OTOF-GT PROGRAM IN H1 2023
* SENS-401 IN CIO: CLINICAL TRIAL APPLICATION FILING
CONFIRMED IN
H2 2021
* SENS-401 FOR HEARING PRESERVATION IN COMBINATION WITH
COCHLEAR
IMPLANTATION: TO BEGIN FIRST CLINICAL TRIAL WITH COCHLEAR
LIMITED
* H2 STRATEGY AND PROSPECTS FOR CASH: INTENDS TO USE NEW
FUNDS TO
DEVELOP ITS CURRENT GENE THERAPY PROGRAMS, SUPPORT ITS
PHARMACOLOGY AND CLINICAL STUDIES OF SENS-401 AND FOR GENERAL
CORPORATE PURPOSES
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H2
2021 -
SUBMISSION OF CLINICAL TRIAL APPLICATION FOR SENS-401 CIO STUDY
IN ADULTS
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H2
2021 -
SUBMISSION OF CLINICAL TRIAL APPLICATION FOR PILOT STUDY
SENS-401 WITH COCHLEAR IMPLANT
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: END OF
2021
- TOP LINE DATA READOUT FOR SENS-401 PHASE 2 CLINICAL STUDY IN
SSNHL
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
START OF THE PILOT STUDY SENS-401 IN COMBINATION WITH COCHLEAR
IMPLANTS
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
SENSORION AND INSTITUT PASTEUR DISCLOSING NEXT STEPS FOR THE
USHER-GT PROGRAM
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2022 –
GJB2-GT CANDIDATE SELECTION
* EXPECTED FUTURE MILESTONES AND ESTIMATED TIMELINES: H1
2023 -
SUBMISSION OF THE CLINICAL TRIAL APPLICATION FOR THE OTOF-GT
PROGRAM (CTA/IND)
Source text for Eikon: ID:nBw8K7Vg9a
Further company coverage: ALSEN.PA
(Gdansk Newsroom)
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