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Pharming Group N.V. — Investor Relations & Filings

Ticker · PHARM ISIN · NL0010391025 LEI · 724500DCJ9MPG74JEH91 AS Manufacturing
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Filings indexed 797 across all filing types
Latest filing 2022-10-11 Regulatory Filings
Country NL Netherlands
Listing AS PHARM

About Pharming Group N.V.

https://www.pharming.com/

Pharming Group N.V. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. The company develops and commercializes an innovative portfolio of medicines to serve patients with unmet medical needs. Its portfolio includes protein replacement therapies, precision medicines, small molecules, and biologics.

Recent filings

Filing Released Lang Actions
Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib
Regulatory Filings Classification · 95% confidence The document is a press release dated October 11, 2022, announcing that Pharming has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the drug Leniolisib. This announcement pertains to regulatory submission activity for a product, which is a specific type of corporate action related to drug development and approval processes. It is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a general regulatory filing (RNS). Since the filing describes a specific regulatory submission event (MAA submission) that is not covered by the other specific codes (like DIV, CAP, MANG, etc.), it best fits under the general 'Regulatory Filings' category (RNS) as a significant, non-financial regulatory update, or potentially a specialized filing if one existed for 'Regulatory Submission Announcement'. Given the provided definitions, RNS serves as the most appropriate catch-all for significant, non-standard regulatory news that isn't a financial report or management change.
2022-10-11 English
Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib
Regulatory Filings Classification · 95% confidence The document is a press release, written in Dutch, announcing that Pharming Group N.V. has submitted a Marketing Authorisation Application (MAA) for its drug leniolisib to the European Medicines Agency (EMA). It details the regulatory process (accelerated assessment) and the clinical data supporting the submission. This type of announcement, concerning the filing of regulatory documentation for a product (like an MAA or NDA), is best classified as a general Regulatory Filing announcement, as it is not the final report (10-K, IR) nor a specific management/board change, dividend, or earnings release. Since it is a specific regulatory action announcement that doesn't fit the other specialized codes (like DIV, ER, MANG), the most appropriate general category is Regulatory Filings (RNS), which serves as a fallback for miscellaneous regulatory announcements not covered elsewhere, or potentially a Capital/Financing Update (CAP) if the focus was on fundraising, but here the focus is purely on the regulatory submission for drug approval. Given the context of submitting a dossier to a regulatory body (EMA), RNS is the most suitable fit among the provided options for a non-standard, non-financial periodic report announcement.
2022-10-11 English
Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
Regulatory Filings Classification · 100% confidence The document is a press release dated September 28, 2022, announcing that the US FDA has accepted Pharming's New Drug Application (NDA) for leniolisib for Priority Review, setting a PDUFA date of March 29, 2023. This announcement details regulatory progress, clinical trial results, and provides background information on the drug and the disease (APDS). This type of announcement, focusing on regulatory milestones and clinical data updates outside of a scheduled earnings report, is best classified as a general Regulatory Filing or an announcement related to drug development/regulatory status. Since there is no specific code for 'Regulatory Milestone Announcement' or 'Drug Approval Update', and it is not a full financial report (10-K, IR), an earnings release (ER), or a call transcript (CT), it falls under the general category for significant corporate news that doesn't fit elsewhere, which is Regulatory Filings (RNS). It is a substantive announcement, not just a notice that a report is attached (ruling 2 does not apply).
2022-09-28 Dutch
Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
Regulatory Filings Classification · 95% confidence The document is a press release dated September 28, 2022, announcing that the US FDA has accepted for priority review the New Drug Application (NDA) for leniolisib. It details the clinical data supporting the application and provides commentary from the Chief Medical Officer. This type of announcement, focusing on regulatory milestones (FDA acceptance, PDUFA date) for a drug candidate, is characteristic of a corporate update related to product development and regulatory progress. It is not a full financial report (10-K, IR), a transcript (CT), or a formal dividend/share change notice. It is best classified as a general corporate announcement that falls under the scope of investor relations updates, but given the specific definitions, it most closely aligns with an announcement regarding a significant corporate event or development that isn't explicitly covered by other codes. Since it is a press release announcing a major regulatory step, it is a form of regulatory/corporate news. It is not an Earnings Release (ER) as it contains no financial results. It is not a Legal Report (LTR) as it is positive news about a drug application, not a lawsuit. It is a specific type of corporate news release. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for significant, non-financial, non-management change announcements that are disseminated via press release, although 'IR' (Interim Report) or 'ER' (Earnings Release) are often related to these announcements, this document is purely about regulatory progress. However, since it is a press release announcing a major corporate/regulatory event, and it doesn't fit the specific definitions of ER, CT, DIV, etc., RNS (Regulatory Filings/General Announcement) is the best fit as a catch-all for significant, non-standard filings/announcements.
2022-09-28 English
Earnings Release 2022
Earnings Release Classification · 100% confidence The document explicitly states it presents the "preliminary (unaudited) financial report for the first six months of 2022 ended June 30, 2022." It contains detailed financial summaries, income statement figures, balance sheet data, and management commentary on performance for a six-month period. This structure and content strongly indicate a comprehensive interim financial report, which aligns with the definition of an Interim / Quarterly Report (IR). It is too detailed to be just an Earnings Release (ER) and covers a period shorter than a year, ruling out the Annual Report (10-K). H1 2022
2022-09-23 English
6-K
Regulatory Filings
2022-08-04 English

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