June 29, 2020 / 11:49 AM / 11 days ago

BRIEF-Intercept Receives Complete Response Letter From FDA For Obeticholic Acid For The Treatment Of Fibrosis Due To Nash

June 29 (Reuters) - Intercept Pharmaceuticals Inc:

* INTERCEPT RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR OBETICHOLIC ACID FOR THE TREATMENT OF FIBROSIS DUE TO NASH

* INTERCEPT PHARMACEUTICALS - CRL INDICATED FDA DETERMINED THAT PREDICTED BENEFIT OF OCA BASED ON A SURROGATE HISTOPATHOLOGIC ENDPOINT REMAINS UNCERTAIN

* INTERCEPT PHARMACEUTICALS - FDA RECOMMENDS CO SUBMIT ADDITIONAL POST-INTERIM ANALYSIS EFFICACY AND SAFETY DATA FROM ONGOING REGENERATE STUDY

* INTERCEPT PHARMACEUTICALS INC - FDA RECOMMENDS LONG-TERM OUTCOMES PHASE OF ONGOING REGENERATE STUDY SHOULD CONTINUE Source text for Eikon: Further company coverage:

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