NEW YORK, May 22, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating potential claims on behalf of investors who purchased Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) securities. Click Here To Join Investigation.
If you purchased Intercept securities and would like to discuss our investigation, please click here, or contact us by emailing jcampisi@kaplanfox.com or calling (212) 329-8571.
On May 19, 2023, Intercept announced the outcome of the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting to review the Company’s New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). Twelve of 16 voting-eligible GIDAC members voted “no” (with two abstentions) on the voting question, “given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?” Fifteen of 16 voting-eligible GIDAC members (with no abstentions) voted to “defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered.”
On May 18, 2023, trading of Intercept’s shares on Nasdaq were halted at $13.56 per share in advance of the GIDAC meeting.
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If you have any questions about this investigation, please contact:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571
E-mail: jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
