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What regulatory filings or inspection findings mention Neurocept in the last two years?
Executive summary
Available reporting and filings in the provided results show multiple regulatory references to Neurocrine Biosciences in 2024 — notably FDA acceptance and approval activity tied to crinecerfont and a separate FDA approval for a Neurocrine drug in December 2024 — but I find no inspection findings or enforcement actions that mention "Neurocept" in the last two years in the provided sources (available sources do not mention Neurocept) [1] [2] [3].
1. What the filings say: Neurocrine’s FDA submissions and approvals
Neurocrine publicly announced that the U.S. Food and Drug Administration accepted New Drug Applications and granted priority review for crinecerfont for pediatric and adult congenital adrenal hyperplasia (CAH), with PDUFA dates referenced toward the end of 2024; the company framed this as an important regulatory milestone in its news release [1]. Neurocrine’s fiscal reporting and press materials also reference anticipated regulatory submissions for crinecerfont in 2024 and related PDUFA timing, showing the firm consistently highlighted FDA interaction around that program [4] [2].
2. Approved product mentions in media: Reuters’ summary of an FDA approval
Reuters reported that the FDA approved a Neurocrine Biosciences drug in December 2024 to treat a genetic disorder, citing the FDA website as its source [3]. Neurocrine’s own financial release also notes an FDA approval in December 2024 described as an adjunctive treatment to glucocorticoid replacement for classic CAH in patients four years and older, which aligns with the company’s public filings [2].
3. SEC/Investor filings as a place to search for regulatory detail
Neurocrine maintains SEC and investor relations filing pages where more granular regulatory disclosure often appears — including risk factors, regulatory milestones, and references to FDA interactions — and these are the formal sources to consult for regulatory filings and any inspection notices that affect the company [5]. The provided investor pages are listed but specific SEC exhibits or inspection reports mentioning Neurocrine were not included in the search results [5].
4. What I could not find: "Neurocept" in regulatory or inspection records
The search results do include multiple items referencing a product or brand named "Neurocept" in consumer review pages and supplement‑review sites, but none of the provided regulatory or inspection documents (FDA, SEC, Reuters, company press releases) mention Neurocept or regulatory inspection findings for that name in the last two years. Therefore, available sources do not mention Neurocept in regulatory filings or inspection findings [6] [7] [8].
5. Distinguishing similarly named entities — why names matter
Neurocrine Biosciences is a publicly listed pharmaceutical company that appears in official regulatory and SEC contexts in these results [5] [2]. By contrast, "Neurocept" in the provided results appears in consumer review and marketing contexts (Trustpilot, supplement reviews), not in formal FDA or SEC filings. Confusing the two can lead to inaccurate conclusions about regulatory status; the current reporting treats them as distinct [6] [7].
6. Where to look next for inspection findings or enforcement records
For authoritative inspection findings you should check: FDA inspection/483 databases, FDA press releases or Warning Letters pages, and the SEC EDGAR filings (Form 8‑K, 10‑K) and related exhibits for Neurocrine. The Neurocrine investor SEC/filings page is a starting point for company disclosures [5]. The provided search set did not include FDA inspection reports, warning letters, or SEC exhibits that explicitly document inspections or enforcement for Neurocrine or for an entity named Neurocept (available sources do not mention FDA inspection findings for either name).
7. Conflicting coverage and limitations of sources
The sources agree that Neurocrine had active regulatory filings and at least one FDA approval event in late 2024 [1] [3] [2]. However, the dataset is limited: it contains corporate press releases, Reuters coverage, and SEC landing pages but lacks direct copies of FDA approval letters, inspection 483s, Warning Letters, or SEC exhibits naming inspection outcomes. I therefore cannot assert the presence or absence of inspection findings beyond saying they are not present in the supplied material (available sources do not mention inspection findings) [5] [1].
8. Bottom line and action items for verification
Based on the provided material, Neurocrine had key regulatory filings and at least one FDA approval in late 2024 [1] [3] [2]. The name "Neurocept" appears only in consumer‑facing review content in the results and not in regulatory filings; the supplied reporting does not show any inspection findings for Neurocept in the last two years [6] [7]. If you want definitive inspection records, I recommend searching the FDA Warning Letters and Inspection Database and Neurocrine’s EDGAR filings for 8‑K or exhibit disclosures, since those are the public venues that would list inspection outcomes or enforcement actions [5].