Neorcept

1. What the record actually covers: Intercept’s arc, not “Neorcept”

None of the supplied sources mention “Neorcept”; they primarily document Intercept Pharmaceuticals’ regulatory and corporate developments — including FDA doubts about obeticholic acid’s benefit/risk, a failed accelerated approval pathway for a fatty‑liver indication, and the Alfasigma buyout ^{[3] [1] [6]}. If you meant Neorcept as a product, company, or misspelling, available sources do not mention it (not found in current reporting).

2. The regulatory chronology that matters

Reporting shows a string of FDA setbacks for Intercept’s lead molecule. FDA advisers and staff concluded available data did not clearly show clinical benefit and raised safety concerns, and the agency declined key approvals — developments that depressed the company’s prospects in NASH and prompted strategic retrenchment ^{[3] [7]}. More recently, Intercept voluntarily withdrew Ocaliva for PBC from the U.S. market after the FDA requested action and placed related clinical trials on hold ^{[4] [5]}.

3. Financial and ownership outcome: a sale, not a comeback

Following years of regulatory turbulence, Intercept agreed to be acquired by Italy’s Alfasigma for roughly $800 million ($19 per share) in 2023; the acquisition closed and Intercept became a wholly owned Alfasigma subsidiary ^{[1] [6] [2]}. Contemporary investor pages confirm Alfasigma completed the tender offer and integrated Intercept under its corporate umbrella ^{[8] [9]}.

4. What the sources say about Ocaliva (obeticholic acid)

Ocaliva is the brand name of obeticholic acid and was initially approved in an accelerated pathway for primary biliary cholangitis (PBC); later trials and regulatory review raised questions about both modest efficacy and safety signals (including liver injury concerns), which underpinned FDA advisory committee skepticism and subsequent regulatory refusals for expanded indications ^{[7] [3]}. Intercept’s own site and press material state the company announced withdrawal of Ocaliva from the U.S. PBC market ^{[5] [10]}.

5. Competing perspectives and implicit agendas in the coverage

Industry and financial coverage emphasize two competing narratives. One narrative frames Intercept as a cautionary biotech tale: a once‑highly valued firm undone by safety signals and insufficient confirmatory evidence, culminating in a modest sale price ^{[7] [1]}. Another narrative in corporate communications and some investor materials highlights corporate actions taken responsibly (voluntary withdrawal, patient support contacts) and the strategic acquisition by Alfasigma as a continuation of the drug-development story under new ownership ^{[5] [11] [6]}. Note the agendas: financial outlets stress valuation loss; company/press pages emphasize orderly transitions and patient communications.

6. What we still don’t know from these sources

Available reporting documents high‑level regulatory outcomes and the acquisition, but does not provide granular clinical data, individual patient outcomes, internal FDA deliberations beyond advisory votes, or detailed current plans by Alfasigma for the obeticholic acid program beyond public statements (available sources do not mention these specifics) ^{[3] [4] [6]}.

7. If you meant something else by “Neorcept” — next steps

If “Neorcept” is a company, product, or term you encountered, please share the context or the source. Based on the supplied search results, the closest match in subject matter is Intercept Pharmaceuticals and Ocaliva/obeticholic acid; any further reporting or a corrected name would let me search within the provided material and produce targeted context and citations (not found in current reporting).

Summary takeaway: the supplied sources document Intercept’s troubled regulatory path for obeticholic acid, its subsequent voluntary withdrawal of Ocaliva from the U.S. PBC market after FDA action, and the company’s acquisition by Alfasigma — but they do not mention “Neorcept” ^{[3] [4] [1] [5]}.