Skip to main content
Pharming Group N.V. logo

Pharming Group N.V. — Investor Relations & Filings

Ticker · PHARM ISIN · NL0010391025 LEI · 724500DCJ9MPG74JEH91 AS Manufacturing
Open in API
Filings indexed 797 across all filing types
Latest filing 2023-02-21 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 announces first patient enrolled in pediatric clinical trial of leniolisib
Regulatory Filings Classification · 100% confidence The document is a press release dated February 21, 2023, announcing that the first patient has been enrolled in a Phase III clinical trial for the drug leniolisib for APDS. It details the trial design, quotes medical experts, references previous trial data published in 'Blood', and mentions ongoing regulatory reviews (FDA priority review, EMA MAA evaluation). This content is characteristic of an initial announcement of significant operational or clinical progress, rather than a comprehensive financial report (10-K, IR), a formal regulatory filing, or a transcript. It is a direct announcement of company news regarding drug development, which aligns best with an Earnings Release (ER) if it were tied to a reporting period, or more generally, a Regulatory Filing (RNS) if no other category fits. However, given the focus on clinical trial updates and regulatory milestones, it functions as a key operational update. Since it is not a formal financial report, a transcript, or a specific governance/shareholder document, and it is a direct announcement of news rather than an announcement *about* a report (RPA), the most appropriate general category for significant, non-financial, non-governance news is Regulatory Filings (RNS), as it is a public disclosure of material information. However, in many financial databases, press releases detailing clinical trial progress are often categorized under a broader 'News Release' or sometimes grouped with Earnings Releases if they are frequent. Given the provided definitions, this is a material announcement about drug development. It is not an ER (which focuses on financial results), nor is it a specific legal/governance/financing document. Therefore, RNS (Regulatory Filings/Miscellaneous Announcement) is the best fit as a catch-all for material operational news that doesn't fit elsewhere.
2023-02-21 English
6-K
Regulatory Filings
2023-02-17 English
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
Regulatory Filings Classification · 95% confidence The document is a press release from Pharming Group N.V. dated February 16, 2023, providing an update on the European Medicines Agency (EMA) review timeline for their drug leniolisib. It discusses regulatory interactions (EMA/FDA), clinical trial data, and future expectations regarding market approval. This type of announcement, which communicates key operational and regulatory milestones outside of mandated periodic financial reports (like 10-K or IR), typically falls under general regulatory announcements or investor relations updates. Since it is not a full financial report (10-K, IR), an earnings release (ER), a management discussion (MDA), or a specific transaction notice (DIV, CAP, etc.), it best fits the general 'Regulatory Filings' (RNS) category, which serves as a broad category for non-standard, material company announcements, especially those concerning regulatory progress in the EU/US. The document length (11,000 chars) is substantial enough that it is not merely an announcement of a report (RPA), but the report itself (a press release detailing regulatory progress).
2023-02-16 Dutch
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
Regulatory Filings Classification · 95% confidence The document is a press release dated February 16, 2023, providing an update on the regulatory review process by the European Medicines Agency (EMA) for the drug leniolisib for APDS. It discusses the shift to a standard review timetable, mentions the FDA review timeline (PDUFA goal date of March 29, 2023), and provides background on the drug and the disease. This content is characteristic of an announcement regarding ongoing regulatory or clinical progress, which is typically disseminated via an Earnings Release (ER) if it contains key financial/operational updates, or sometimes falls under Regulatory Filings (RNS) if it's purely regulatory news. Since it provides a specific update on a regulatory milestone (EMA review status) and mentions the FDA timeline, it functions as a key operational/regulatory update announcement, fitting best under Earnings Release (ER) as these often include operational milestones alongside financial results, or if it were purely regulatory, RNS. Given the context of providing an update on a key product's regulatory status, ER is often used for such material news outside of formal quarterly filings. However, since it is specifically about regulatory review status and not financial results themselves, and it is a formal announcement, it is most accurately classified as a general Regulatory Filing (RNS) or potentially an Earnings Release (ER) if it were tied to a reporting period. Since it is a specific, non-financial regulatory update, RNS serves as the best fit among the provided options for a general regulatory announcement that isn't a specific form like 10-K or a dividend notice. Given the nature of the update (EMA/FDA review status), it is a material regulatory announcement. I will classify it as RNS as it is a general regulatory announcement that doesn't fit the other specific categories.
2023-02-16 English
Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH’s Blood
Earnings Release Classification · 95% confidence The document is a press release from Pharming Group N.V. announcing that the positive results from their Phase 3 clinical study of leniolisib for APDS have been published in the peer-reviewed medical journal 'Blood'. The text details the study outcomes (efficacy and safety) and includes quotes from management and a foundation representative. This is a standard announcement regarding clinical trial data dissemination, which is typically classified as an Earnings Release (ER) if it contains key financial/operational results, or sometimes as a Regulatory Filing (RNS) if it's a general update. Since this announcement focuses heavily on clinical trial results and publication, it aligns best with an Earnings Release (ER) which often includes significant operational milestones like major publication announcements, or potentially an Investor Presentation (IP) if it were the presentation itself. However, given the structure (press release format announcing publication of study data), and the lack of explicit quarterly financial figures (though it references prior results), ER is the closest fit for a major operational/clinical update announcement. It is not a full report (10-K, IR), nor a presentation (IP), nor a simple announcement of a report's release (RPA). It is the announcement of significant clinical data, which often falls under ER or RNS. Given the depth of the clinical data summary, ER is chosen over the generic RNS. FY 2022
2022-12-07 English
Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH’s Blood
Regulatory Filings Classification · 91% confidence The document is a press release from Pharming Group N.V. announcing that positive results from a Phase 3 clinical study of their drug leniolisib have been published in the peer-reviewed journal *Blood*. The text focuses on summarizing the key findings (efficacy, tolerability) and providing context about the disease (APDS) and the drug. This structure—announcing the release/publication of clinical data—is characteristic of an Earnings Release (ER) or a general press release announcing a significant corporate/scientific event. Since it is not a full financial report (10-K, IR), a transcript (CT), or a formal regulatory filing detailing insider trades or capital changes, it fits best as an Earnings Release (ER) which often includes operational/clinical highlights, or potentially a Regulatory Filing (RNS) if no other category fits. Given the focus on clinical trial results and publication, it is a major operational announcement. However, it is not an *Earnings* Release in the traditional sense (quarterly financial summary). It is a scientific/operational announcement. Since there is no specific category for 'Clinical Trial Result Announcement', we must choose the closest fit. It is not a proxy statement (DEF 14A), a management discussion (MDA), or a formal report (AR, IR). It is an announcement of a publication. If the document were merely announcing that a report *is available*, it would be RPA. Since this document *contains* the substance of the announcement (the results), it functions as a high-level summary of operational progress. In the context of financial reporting databases, major operational/scientific announcements that are not formal SEC filings often fall under the general 'Regulatory Filings' (RNS) category if they don't fit elsewhere, or sometimes an 'Earnings Release' (ER) if they are time-sensitive updates. Given the content is a press release detailing study results, and not a formal financial statement, 'RNS' (Regulatory Filings/General Announcement) is the most appropriate fallback for a significant, non-standard announcement, although 'ER' is sometimes used broadly for major operational updates. I will classify it as RNS as it is a general regulatory/corporate announcement that doesn't fit the specific financial or governance codes.
2022-12-07 English

Browse filings by year

22 years

Report missing filing

Can't find a specific document? Let us know and we'll add it within 24 hours.

We will notify you once the filing is added.
Report sent
Thank you. We will check the data and update it shortly.