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 5/30, check Exhibit 99.1 for deets.

AI Summary

Pharming Group N.V. filed a Form 6-K on May 30, 2024, to furnish a press release dated May 30, 2024. The filing itself does not contain specific financial figures or operational updates beyond referencing the attached press release as Exhibit 99.1.

Why It Matters

This filing indicates that Pharming Group N.V. is providing an update to the market via a press release, which may contain important information for investors.

Risk Assessment

Risk Level: low — This is a routine filing to submit a press release, not containing new financial data or significant corporate actions within the 6-K itself.

Key Players & Entities

• Pharming Group N.V. (company) — Registrant
• May 30, 2024 (date) — Filing and Press Release Date

FAQ

From the Filing

0001828316-24-000027.txt : 20240530 0001828316-24-000027.hdr.sgml : 20240530 20240530171916 ACCESSION NUMBER: 0001828316-24-000027 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20240530 FILED AS OF DATE: 20240530 DATE AS OF CHANGE: 20240530 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 IRS NUMBER: 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: 241006662 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 pharminggroupprovidesupdat.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 May 2024 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 May 30, 2024. EXHIBIT INDEX Exhibit No. Description 99.1 Pharming Group provides update on ongoing regulatory review of leniolisib for the treatment of APDS in the European Union 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/ Sijmen de Vries Name: Sijmen de Vries Title: CEO Date: May 30, 2024 Pharming Group provides update on ongoing regulatory review of leniolisib for the treatment of APDS in the European Union Leiden, the Netherlands, May 30, 2024: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces today an update on the ongoing review of its Marketing Authorisation Application (MAA) for leniolisib for the treatment of adult and pediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta syndrome (APDS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the May 27-30 CHMP meeting, Pharming received an updated List of Outstanding Issues (LoOI) from the CHMP. The LoOI affirmed the positive clinical benefit and safety of leniolisib, in agreement with the assessment by the Ad Hoc Expert Group (AEG), and included one remaining chemistry, manufacturing and controls (CMC) request. The CMC request relates to the definition of regulatory starting materials used in the manufacturing process for leniolisib. As Pharming is committed to meeting all of the CHMP’s specific requirements, additional data and quality controls were provided and Pharming proposed implementation of the CMC request post-approval. The CHMP requested that this work be completed pre-approval and has granted Pharming an extension to January 2026 to submit a response. Pharming has already initiated the manufacturing activities requested by the CHMP, which it plans to complete prior to t