Welcome to our dedicated page for PHARM news (Ticker: PHARM), a resource for investors and traders seeking the latest updates and insights on PHARM stock.
Pharming Group N.V. (PHARM) is a global biopharmaceutical company listed on Euronext Amsterdam and Nasdaq that focuses on rare, debilitating, and life‑threatening diseases. Its news flow reflects both commercial performance and clinical development across a portfolio that includes the recombinant C1 esterase inhibitor RUCONEST® for acute hereditary angioedema (HAE) attacks and Joenja® (leniolisib), an oral PI3Kδ inhibitor for activated phosphoinositide 3‑kinase delta syndrome (APDS).
On this page, readers can follow company announcements on quarterly and annual financial results, preliminary revenue updates, and guidance changes, where Pharming explains how demand for RUCONEST® and Joenja® contributes to its revenue mix. The company also issues news about participation in healthcare and investor conferences, such as rare disease summits and global healthcare meetings, where management discusses markets like HAE and APDS.
Pharming’s communications highlight regulatory and clinical milestones, including U.S. FDA Priority Review of a supplemental New Drug Application for leniolisib in children with APDS aged 4 to 11 years, Phase II proof‑of‑concept trials in primary immunodeficiencies with immune dysregulation, and pivotal studies such as the FALCON trial of KL1333 in mitochondrial DNA‑driven mitochondrial disease. Scientific updates around major congresses feature new clinical, economic, and real‑world data on RUCONEST® and Joenja®.
Investors and followers of PHARM can use this news feed to track developments in Pharming’s rare disease portfolio, including commercial updates, pipeline progress, organizational changes, and index movements such as its promotion to the Euronext AMX® (MidCap) index.
Pharming Group (PHARM) announced that shareholders approved all proposals at the 2026 Annual General Meeting of Shareholders held on May 28, 2026.
Approvals covered appointing KPMG Accountants as external auditor for 2026–2028, updating non-executive director remuneration, and renewing share issuance and share repurchase authorizations.
Pharming (PHARM) received European Commission marketing authorization for Joenja (leniolisib), the first and only approved treatment in the EU for activated PI3K delta syndrome (APDS) in patients aged 12 and older.
First EU launch is expected in Germany in Q3 2026, with further roll-out after national reimbursement decisions. The approval, based on a Phase II/III trial and long-term extension data, is valid in all 27 EU states plus Norway, Iceland and Liechtenstein, and supports Pharming’s rare disease expansion alongside existing approvals in the US, UK, Japan, Australia and Israel.
Pharming (Euronext: PHARM / Nasdaq: PHAR) announced multiple poster presentations at the Clinical Immunology Society Annual Meeting (May 6–9, 2026, New Orleans) reporting interim long‑term extension data for leniolisib in pediatric APDS (ages 4–11), clinical experience in CVID/CVID‑like disorders, and details on ongoing Phase 2 trials (NCT06897358, NCT06549114).
The posters cover safety, efficacy, symptom changes, caregiver burden, registry findings, and study design/baseline characteristics; select sessions occur May 7–8, 2026.
Pharming (PHARM) reported 1Q 2026 total revenues of US$72.4m (down 8% YoY), with RUCONEST at US$58.4m (‑15%) and Joenja at US$14.1m (+34%). The company generated positive operating cash flow of US$2.0m, reaffirmed 2026 revenue guidance of US$405–425m, and announced regulatory wins: Joenja approved in Japan and a positive CHMP opinion in Europe.
Key pipeline updates include pediatric sNDA resubmission steps for Joenja, ongoing Phase II PID trials with H2 2026 readouts, and enrollment completion for the pivotal napazimone study.
Pharming Group (Euronext: PHARM / Nasdaq: PHAR) will report preliminary unaudited Q1 2026 financial results and provide a business update on Thursday, May 7, 2026. Management will host a conference call and live webcast at 13:30 CEST / 07:30 EDT.
According to Pharming, investors and analysts must register in advance for dial-in or webcast access; questions will be taken only from dial-in attendees. The webcast and a replay will be available on the company investor website.
Pharming (Euronext: PHARM / Nasdaq: PHAR) announced its 2026 Annual General Meeting of Shareholders will be held on Thursday, May 28, 2026 at 14:00 CET in Oegstgeest, the Netherlands, and via live webcast.
Agenda items include appointing KPMG N.V. as external auditor for 2026–2028, proposed amendments to the Board remuneration policy for Non‑Executive Directors, and renewal of authorizations to issue and repurchase shares. Meeting documents and proxy materials are available on the company website under Investors/Shareholder Meetings.
Pharming (Euronext: PHARM / Nasdaq: PHAR) announced management will participate in investor conferences in April 2026. Fabrice Chouraqui and Anurag Relan will present at the Needham Virtual Healthcare Conference on April 13, 2026 at 08:45 AM ET/14:45 CET. A live webcast and replay will be available in the company’s Upcoming Events and News sections.
Pharming will also attend the Van Lanschot Kempen Life Sciences Conference in Amsterdam on April 15, 2026. For one-on-one meeting requests, contact investor@pharming.com or your conference representative.
Pharming Group (Euronext: PHARM / Nasdaq: PHAR) announced the filing of its 2025 Annual Report and the 2025 Annual Report on Form 20-F with the U.S. SEC on April 2, 2026. The Annual Report for the year ended December 31, 2025 is available online at the company's annual report site and Investors pages.
The Form 20-F will be accessible via the company's Investors/SEC filings page and through the SEC website once posted.
Pharming (EURONEXT:PHARM) announced a positive CHMP opinion recommending marketing authorization for Joenja (leniolisib) for treatment of APDS in patients aged 12 and older. A final European Commission decision is expected in Q2 2026, roughly two months after March 27, 2026.
The recommendation is based on a randomized Phase II/III trial (31 patients) showing statistically significant improvements in immune dysregulation and immunodeficiency, and on long-term open-label data from 37 patients with median three-year exposure. Joenja is already approved in the United States, United Kingdom, and Japan.
Pharming (NASDAQ:PHAR / Euronext:PHARM) announced that Japan's MHLW approved Joenja (leniolisib) on March 24, 2026 for treatment of activated PI3K delta syndrome (APDS) in patients aged 4 years and older.
This is the first treatment approved in Japan for APDS and the first global approval for children aged 4–11; approval was based on positive Phase III data showing reduced lymphadenopathy and increased naïve B cells.