Pharming Group N.V. Files 6-K with Press Release

TL;DR

Pharming Group N.V. dropped a 6-K with a press release on Oct 1st - check Exhibit 99.1 for details.

AI Summary

Pharming Group N.V. filed a Form 6-K on October 1, 2025, to furnish a press release dated October 1, 2025. The filing itself does not contain specific financial details or operational updates beyond the fact that a press release is being provided as Exhibit 99.1.

Why It Matters

This filing indicates that Pharming Group N.V. is providing an update to the SEC, likely containing material information for investors, though the specifics are in the attached press release.

Risk Assessment

Risk Level: low — The filing is a routine disclosure of a press release and does not contain immediate financial or operational risks.

Key Players & Entities

• Pharming Group N.V. (company) — Registrant
• October 1, 2025 (date) — Filing and Press Release Date

FAQ

From the Filing

0001828316-25-000043.txt : 20251001 0001828316-25-000043.hdr.sgml : 20251001 20251001061138 ACCESSION NUMBER: 0001828316-25-000043 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20251001 FILED AS OF DATE: 20251001 DATE AS OF CHANGE: 20251001 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Pharming Group N.V. CENTRAL INDEX KEY: 0001828316 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39822 FILM NUMBER: 251362491 BUSINESS ADDRESS: STREET 1: DARWINWEG 24 CITY: LEIDEN STATE: P7 ZIP: 2333 CR BUSINESS PHONE: 31 (0)71 5247 400 MAIL ADDRESS: STREET 1: DARWINWEG 24 CITY: LEIDEN STATE: P7 ZIP: 2333 CR FORMER COMPANY: FORMER CONFORMED NAME: Pharming Group Group N.V. DATE OF NAME CHANGE: 20201014 6-K 1 pharminggroupannouncesusfd.htm 6-K Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of October 2025 Commission File Number: 001-39822 Pharming Group N.V. (Exact Name of Registrant as Specified in Its Charter) Darwinweg 24 2333 CR Leiden The Netherlands (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F ☒ Form 40-F ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Pharming Group N.V., or the Company, dated October 1, 2025. EXHIBIT INDEX Exhibit No. Description 99.1 Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application for leniolisib in children with APDS aged 4 to 11 years SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Pharming Group N.V. By: /s/ Fabrice Chouraqui Name: Fabrice Chouraqui Title: CEO Date: October 1, 2025 Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application for leniolisib in children with APDS aged 4 to 11 years • If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency • Decision based on positive data from multinational Phase III study in children aged 4 to 11 years with APDS • PDUFA target action date of January 31, 2026 Leiden, the Netherlands, October 1, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM&#59; Nasdaq: PHAR) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. The sNDA submitted to the FDA is based on positive data from the multinational, single-arm Phase III study in children aged 4 to 11 years, which showed improvements over 12 weeks in two clinically relevant hallmarks of the condition, reduced lymphadenopathy and increased naïve B cells, together indicating a corr