[{"_1":2,"_3":-5,"_4":-5},"loaderData",{"_5":6,"_7":8},"actionData","errors","root",{"_101":102},"en-item",{"_9":10,"_10":11},"kind","item",{"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27,"_28":29,"_30":31,"_32":31,"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":-5,"_48":49,"_50":-5,"_51":-5,"_52":53,"_54":55,"_56":57,"_58":42,"_59":42,"_60":61,"_62":42,"_63":64},"id","cag721dk2ufsobkzu1xmt3eg6","revision",2,"title","Pharming Group N.V.公布leniolisib在遗传性PIDs中的II期临床数据","originalTitle","6-K - Pharming Group N.V. (0001828316) (Filer)","summary","Pharming Group N.V.在ESID 2026会议上公布了leniolisib在遗传性原发性免疫缺陷（PIDs）中的II期临床试验初步数据，显示药物在多个免疫失调指标上表现出积极效果，包括脾脏体积减少、淋巴结缩小、肺功能改善和肝纤维化改善。所有完成试验的12名参与者均继续参加为期三年的扩展研究。","reason","Pharming Group N.V.在ESID 2026会议上公布了leniolisib在遗传性原发性免疫缺陷（PIDs）中的II期临床试验初步数据，显示药物在多个免疫失调指标上表现出积极效果。","source",{"_12":92,"_93":94,"_9":95,"_96":42,"_97":98,"_99":100},"links",{"_89":90,"_78":91},"publishedAt","2026-10-14T10:03:16.000Z","discoveredAt","2026-10-14T10:06:07.149Z","timelineAt","category","ai-products","tags",[84,85,86,87,88],"stockSymbols",[83],"score",67,"selected",true,"channel","news","story",{"_73":74,"_16":75},"x","readingMode","full","author","language","body",{"_64":77,"_78":-5,"_79":80,"_81":82},"outline",[],"relatedStories",[76],"indexable","markdownAvailable","group",{"_65":66,"_45":67,"_68":69,"_70":71,"_72":71},"hasTranslation","bodyLanguage","zh","factId","fx1P58ihoxTs",{"_73":74,"_16":75},"reportCount",1,"additionalSourceCount",0,"developmentCount","publicId","e8ecc6d5-bd01-4f65-adb1-ae5485d12965","Pharming Group N.V.公布leniolisib II期临床数据",{"_73":74,"_16":75},"

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 2026

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 14, 2026.

EXHIBIT INDEX


Exhibit No.		Description

99.1		Pharming presents positive Phase II topline data for leniolisib in genetic PIDs with immune dysregulation at ESID 2026

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/ Kenneth Lynard

	Name:	Kenneth Lynard
	Title:	Interim Co-CEO & CFO

Date: October 14, 2026

$\"logo_pharmingxoriginal.jpg\"$

Pharming presents positive Phase II topline data for leniolisib in genetic PIDs with immune dysregulation at ESID 2026

•First clinical data for leniolisib in a larger group of PID participants beyond APDS, supporting the potential of targeted PI3Kδ inhibition to address immune dysregulation

•Leniolisib was well-tolerated, with benefits observed across multiple measures of immune dysregulation, including improvement in lymphoproliferation and positive trends in lung and liver disease markers

•All participants who completed the study elected to continue receiving treatment in a long-term extension study

Leiden, the Netherlands, October 14, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today presented positive topline data from its Phase II trial of leniolisib in genetically identifiable primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kδ signaling. The data, accepted as a late-breaking abstract, were presented as a poster at the 22nd Biennial Meeting of the European Society for Immunodeficiencies (ESID), taking place October 14-17, 2026, in Maastricht, the Netherlands.

“These data provide the first clinical evidence that leniolisib can produce improvements across multiple manifestations of immune dysregulation in conditions beyond APDS, with encouraging signals in lymphoproliferation, pulmonary function, and liver disease,” said Anurag Relan, Chief Medical Officer of Pharming. “The consistent reductions in spleen volume in nearly all evaluable participants are particularly encouraging. Splenomegaly is a measurable sign of lymphoproliferation, and these reductions suggest leniolisib is acting on a core driver of the disease process. The trends in pulmonary findings are also particularly noteworthy, as even small improvements in progressive lung disease were not expected over such a short treatment period.”

这项试验是一项单臂、开放标签、患者内剂量递增的II期研究，纳入了13名由CTLA4、SOCS1、NFKB1或FAS基因变异驱动的可遗传识别的原发性免疫缺陷病（PID）患者。13名参与者中有9名同时被诊断为常见变异型免疫缺陷病（CVID）。参与者每天两次服用leniolisib，持续20周，剂量从10毫克（4周）逐步增加到30毫克（4周）再到70毫克（12周）。关键结果包括：

•安全性：leniolisib在与失调的PI3Kδ信号相关的4种基因型中总体耐受性良好。安全性发现与已知疾病特征一致，感染是最常见的不良事件（AE），未发现新的安全性信号。所有治疗相关的AE均为1级。两名研究参与者经历了与leniolisib无关的严重AE。一名有门静脉高压病史的参与者因急性肝炎提前终止治疗。

•脾脏体积：平均较基线减少26.4%（n=11），在11名可评估参与者中有10名观察到减少。

$\"logo_pharmingxoriginal.jpg\"$

•淋巴结：靶病灶大小平均较基线减少33.7%（n=4），所有4名可评估参与者均观察到减少。

•肺功能：在基线时存在气体交换障碍的参与者（n=7）中，肺一氧化碳弥散量（DLCO）的预测百分比平均增加了8.0%。与此一致的是，5名可评估参与者中有4名的CT评估间质性肺病评分也下降了。

•肝脏：在基线时肝硬度升高的3名参与者中有2名观察到肝硬度改善。

•所有12名完成研究的参与者都参加了为期三年的扩展研究（NCT06990529）。

莱兰博士补充道：“这些结果进一步支持了我们更广泛的策略，即在由免疫失调表型的PID中评估PI3Kδ抑制，无论遗传原因如何。我们期待在11月报告单独针对CVID的II期试验的初步结果，这将为我们针对更广泛的CVID人群的潜在注册研究计划提供依据。”

根据估计的患病率，这些可遗传识别的PID和具有免疫失调的CVID代表的潜在患者群体比APDS更广泛，遗传性PID的患病率约为每百万人口7.5例，CVID的患病率约为每百万人口39例，包括遗传性PID和CVID人群之间的重叠，而APDS的患病率约为每百万人口1.5例。

关于leniolisib

Leniolisib是一种口服的、选择性的磷脂酰肌醇3-激酶δ（PI3Kδ）抑制剂，旨在针对原发性免疫缺陷病（PIDs）中由PI3Kδ驱动的免疫失调。

Leniolisib以商品名Joenja®上市，在多个国家获批并可商业购买，用于治疗激活的磷脂酰肌醇3-激酶δ综合征（APDS），这是一种由免疫失调和缺陷引起的超罕见且进行性的PID。

除了APDS，leniolisib还在临床试验中评估用于其他由PI3Kδ驱动的免疫失调表型的PID，包括常见变异型免疫缺陷病（CVID）。这些PID有许多相同的临床表现，包括淋巴增殖、自身免疫、胃肠道疾病和肺部疾病。leniolisib在这些研究性用途中的安全性和有效性尚未确立。

关于Pharming

Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) 是一家全球生物技术公司，致力于为患有罕见免疫和遗传疾病的人群开发和商业化创新药物。

我们结合专业的科学、医学、监管和商业专长，推进一批已获批药物和开发项目，以解决重大的未满足医疗需求。在患者和更广泛的罕见病社区的洞察指导下，我们致力于为一些最具有挑战性的罕见疾病提供创新疗法。

Pharming 总部位于荷兰莱顿，业务遍及美国和欧洲。

$\"logo_pharmingxoriginal.jpg\"$

如需更多信息，请访问 www.pharming.com 并在 LinkedIn 上关注我们。

如需进一步的公开信息，请联系：

Pharming

Michael Levitan，投资者关系与资本市场副总裁

T: +1 (908) 705 1696

E: investor@pharming.com

Saskia Mehring，企业传播主管

T: +31 6 28 32 60 41

E: media.relations@pharming.com

媒体关系

Julia Deutsch（Lyra Strategic Advisory 代表 Pharming）

E: JDeutsch@lyraadvisory.com

荷兰：Leon Melens（LifeSpring Life Sciences Communication 代表 Pharming）

T: +31 6 53 81 64 27

前瞻性声明

这份新闻稿可能包含前瞻性声明。前瞻性声明是基于管理层当前的预期和假设，涉及已知和未知的风险和不确定性，可能导致实际结果、表现或事件与这些声明中明示或暗示的内容有重大差异。这些前瞻性声明通过使用诸如“aim”（旨在）、“ambition”（雄心）、“anticipate”（预期）、“believe”（相信）、“could”（可能）、“estimate”（估计）、“expect”（期望）、“goals”（目标）、“intend”（打算）、“may”（可能）、“milestones”（里程碑）、“objectives”（目标）、“outlook”（前景）、“plan”（计划）、“probably”（很可能）、“project”（预计）、“risks”（风险）、“schedule”（时间表）、“seek”（寻求）、“should”（应该）、“target”（目标）、“will”（将）及类似术语和短语来识别。前瞻性声明的示例可能包括有关Pharming的候选产品临床前研究和临床试验的时间和进展的声明、Pharming的临床和商业前景，以及Pharming对其预计营运资金需求和现金资源的预期，这些声明受多种风险、不确定性和假设的影响，包括但不限于Pharming临床试验的范围、进展和扩展及其成本影响；以及临床、科学、监管、商业、竞争和技术发展。鉴于这些风险和不确定性，以及在Pharming 2025年年度报告和截至2025年12月31日的20-F表格年度报告中描述的其他风险和不确定性，此类前瞻性声明中讨论的事件和情况可能不会发生，Pharming的实际结果可能与预期或暗示的内容有重大且不利的差异。本新闻稿中包含的所有前瞻性声明均受本部分中包含或提及的警示性声明的全部限定。请读者不要过度依赖前瞻性声明。任何前瞻性声明仅反映本新闻稿发布之日的情况，并基于Pharming在发布之日可获得的信息。Pharming不承担因新信息、未来事件或其他信息而公开更新或修订任何前瞻性声明的义务。

$\"logo_greyxoriginalx.jpg\"$

内部信息

本新闻稿涉及根据欧盟市场滥用条例第7(1)条定义的内幕信息的披露。

","original","zhKind","translation","complete",false,"PHAR","公司与财报","行业与主题","观点与解读","宏观与美联储","其他","aihot","/items/cag721dk2ufsobkzu1xmt3eg6","https://www.sec.gov/Archives/edgar/data/1828316/000182831626000045/0001828316-26-000045-index.htm","rss-sec-xbrl","name","SEC · EDGAR 财务披露","rss","firstParty","iconUrl","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar&exp=1792195200&sig=4eab1165515e57e2","iconSrcSet","/api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-48&exp=1792195200&sig=df95c58c297800b1 48w, /api/img-proxy?u=https%3A%2F%2Fwww.sec.gov%2Fthemes%2Fcustom%2Fuswds_sec%2Fassets%2Fimg%2Ffavicons%2Fapple-touch-icon.png&mode=avatar-96&exp=1792195200&sig=2a4278e6e5e85947 96w","changelogVersion","2026-10-01T08:00"]