GoHealth Soars on Acquisition Proposal, Intercept Pharma Faces FDA Committee Setback for OCA in NASH Treatment
- May 20th, 2023
- 426 views
GoHealth, Inc. (Nasdaq: GOCO) has officially confirmed that it has received a proposal from its two largest shareholders, Centerbridge Partners and NVX Holdings. The proposal entails acquiring all of the outstanding Class A Common Stock and LLC Interests that these shareholders do not already own. The independent members of GoHealth's Board will carefully review the proposal in due course.
On Friday, the market reacted positively to this news, with $GOCO closing at $19.74, experiencing a significant gain of $2.30 (+13.19%).
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) disclosed the outcome of the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting, where they presented their New Drug Application (NDA) for obeticholic acid (OCA) to treat pre-cirrhotic fibrosis caused by nonalcoholic steatohepatitis (NASH).
During the meeting, the voting members of the GIDAC were asked, "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?" Out of the 16 voting-eligible members, 12 voted "no" (with two abstentions), indicating a majority of the committee's disagreement with the benefits of OCA in this particular patient population.
However, the committee also voted on the decision 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." In this vote, 15 of the 16 voting-eligible members (with no abstentions) favored deferring the approval until further clinical outcome data is available from trial 747-303, suggesting that the traditional approval pathway could be pursued after reviewing the additional data.
This outcome highlights the committee's concerns regarding the available efficacy and safety data for OCA in NASH patients with stage 2 or 3 fibrosis. The committee emphasizes the importance of considering clinical outcome data from the ongoing trial, which could provide further insights into the benefits and risks associated with OCA treatment.
$ICPT was halted by Nasdaq on Friday, ahead of the Advisory Committee meeting
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