Welcome to our dedicated page for Pharming Group N.V. SEC filings (Ticker: PHAR), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Pharming Group N.V. SEC filings document a foreign private issuer commercializing rare-disease medicines and reporting through Form 6-K current reports and Form 20-F annual disclosures. The filings cover financial results, revenue trends for RUCONEST® and Joenja® (leniolisib), regulatory developments for APDS, and clinical-program disclosures involving primary immunodeficiencies with immune dysregulation and napazimone (KL1333) in primary mitochondrial disease.
The company's regulatory record also includes annual-report filings, shareholder-meeting materials, auditor appointment matters, remuneration policy proposals, and authorizations related to share issuance and repurchases. These disclosures frame Pharming's governance, capital structure, commercial products, pipeline spending, licensing obligations, and rare-disease development risks.
Pharming Group N.V. reports that the U.S. FDA has accepted its resubmitted supplemental New Drug Application (sNDA) for Joenja (leniolisib) to treat children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. The resubmission follows a Complete Response Letter issued on January 30, 2026 and includes additional analytical data requested by the FDA.
The application seeks approval of 40 mg and 50 mg twice-daily dosing for pediatric patients weighing at least 27 kg, and the FDA has set a PDUFA target action date of October 24, 2026. The filing is supported by Phase III data showing 12-week improvements in lymphadenopathy and naïve B cells, with only mild to moderate treatment-emergent adverse events and no drug-related serious events. Pharming also plans a separate sNDA for lower-weight children later in 2026.
Pharming Group N.V. reported the results of its 2026 Annual General Meeting of Shareholders, where shareholders approved all proposals presented. KPMG Accountants N.V. was appointed as independent external auditor for the financial years 2026 through 2028, replacing Deloitte Accountants B.V. as of May 28, 2026.
Deloitte’s audit reports on the consolidated financial statements for the years ended December 31, 2025 and 2024 contained no adverse opinions, disclaimers, or qualifications, and the company reports no disagreements or reportable events with Deloitte, other than previously disclosed material weaknesses in internal control over financial reporting. Shareholders also approved amendments to the Board remuneration policy, and renewed authorizations for the Board to issue and repurchase shares.
Pharming Group N.V. received European Commission marketing authorization for Joenja® (leniolisib), making it the first approved treatment for activated PI3K delta syndrome (APDS) in the European Union for adults and children aged 12 and older. APDS is a rare primary immunodeficiency, affecting about 1 to 2 people per million worldwide and often diagnosed with a median delay of seven years. The approval, which is valid in all 27 EU Member States plus Norway, Iceland and Liechtenstein, is based on a multinational, triple-blind, placebo-controlled Phase II/III trial in 31 patients and long-term extension data from 37 patients treated for a median of three years. Pharming expects its first European launch in Germany in Q3 2026, with further launches following national reimbursement negotiations, adding to existing Joenja approvals in the U.S., U.K., Japan, Australia and Israel.
Pharming Group N.V. is highlighting new scientific data on its PI3Kδ inhibitor leniolisib at the 2026 Clinical Immunology Society meeting in New Orleans. The company and collaborators are presenting interim results from a long-term extension study of leniolisib in pediatric patients aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
Additional posters cover clinical experience from expanded access use of leniolisib in patients with Common Variable Immunodeficiency (CVID) and CVID-like disorders, as well as study design and baseline characteristics from Phase II trials in primary immunodeficiencies with immune dysregulation. Pharming notes that leniolisib is already approved as a targeted APDS treatment in several countries and is under regulatory review in others, while Phase II studies are ongoing to evaluate its role in broader primary immunodeficiencies.
Pharming Group reported preliminary unaudited first‑quarter 2026 revenue of US$72.4 million, down 8% from a year earlier, as its legacy RUCONEST® franchise declined and Joenja® continued to grow. RUCONEST® revenue fell 15% to US$58.4 million, mainly due to anticipated U.S. inventory drawdowns and the planned exit from non‑U.S. markets. Joenja® revenue rose 34% to US$14.1 million, driven by more U.S. patients on paid therapy and growing international demand.
The company recorded a net loss of US$5.2 million, improved from a US$14.9 million loss a year earlier, with gross profit of US$65.8 million and positive operating cash flow of US$2.0 million. Cash, restricted cash and marketable securities totaled US$171.8 million at March 31, 2026. Pharming reaffirmed 2026 total revenue guidance of US$405–US$425 million and guided total operating expenses to US$330–US$335 million.
Joenja® achieved key regulatory milestones, including approval in Japan for APDS patients aged 4 and older and a positive CHMP opinion in Europe for patients 12 and older. The company resubmitted its U.S. pediatric sNDA for higher Joenja® doses and plans a separate filing for lower doses, while advancing Phase II trials of leniolisib in additional primary immunodeficiencies and enrollment in the pivotal napazimone (KL1333) study.
Pharming Group N.V. has scheduled its 2026 Annual General Meeting of Shareholders for Thursday, May 28, 2026 at 14:00 CET at the Corpus Congress Centre in Oegstgeest, the Netherlands, with a live webcast available.
The agenda includes appointing KPMG N.V. as external auditor for financial years 2026 through 2028, amendments to the remuneration policy for Non-Executive Directors, and renewal of Board authorizations to issue shares (including rights to acquire shares) and to repurchase shares. Meeting materials, including the Notice to Convene, Explanatory Notes, and Proxy, are available on Pharming’s website under Investors/Shareholder Meetings.
Pharming Group N.V. has filed Amendment No. 1 to its Form 20-F mainly to correct and re-file the CEO and CFO Section 906 certifications, which previously referenced an incorrect fiscal period. The amendment also re-files updated Section 302 certifications and a renewed Deloitte Accountants B.V. consent.
All other disclosures from the original Form 20-F for the year ended December 31, 2025 remain unchanged, including financial statements prepared under IFRS and extensive risk factors. These risks highlight the company’s heavy reliance on U.S. RUCONEST® sales and growing, but newer, Joenja® revenues, strong customer concentration with two U.S. specialty pharmacies, and significant competitive, regulatory, manufacturing, and intellectual property uncertainties.
Pharming Group N.V. has filed its 2025 Annual Report for the year ended December 31, 2025. The report is available via annualreport.pharming.com and the Investors/Financial documents section of the company’s website.
The company has also filed its 2025 Annual Report on Form 20-F with the U.S. SEC, which can be accessed through the Investors/SEC filings section on Pharming.com and the SEC website.
Pharming Group N.V. filed its Form 20-F annual report for the year ended December 31, 2025, outlining its rare disease business focused on RUCONEST® for hereditary angioedema and Joenja® (leniolisib) for APDS. RUCONEST® generated about 85% of 2025 revenues, highlighting heavy dependence on a single product and the U.S. market.
The report describes Joenja’s recent approvals in the U.S., U.K., Japan, Australia and Israel, together with extensive forward-looking statements on expanding indications and geographies. Key risks include intense competition in HAE, potential new gene and oral therapies, post-approval safety findings for Joenja®, reliance on a few specialty pharmacies, third‑party manufacturers and CROs, cyber threats, regulatory and reimbursement pressures, and challenges protecting patents. Pharming had 701,680,440 ordinary shares outstanding as of December 31, 2025.
Pharming Group N.V. reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending EU marketing authorization for Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) in patients aged 12 and older. A final European Commission decision is expected in Q2 2026. If approved, Joenja would become the first authorized APDS treatment in the European Union, with a centralized authorization covering all EU Member States plus Norway, Iceland and Liechtenstein. The recommendation is based on a Phase II/III placebo-controlled trial in 31 patients and supporting long-term extension data in 37 patients, showing statistically significant improvements in immune dysregulation and immunodeficiency, alongside a favorable safety profile. Joenja is already approved for APDS in the United States, the United Kingdom and several other markets.