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 (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.
Pharming (Euronext:PHARM / Nasdaq:PHAR) reported strong 2025 results with total revenues up 27% to US$376.1m, driven by RUCONEST® and Joenja® growth. The company delivered US$25.8m operating profit and US$54.7m net cash from operations, and issued 2026 revenue guidance of US$405–425m.
Key development milestones include Phase II leniolisib readouts in H2 2026 and expected FALCON enrollment completion for napazimone in 2026.
Pharming Group (Euronext: PHARM / Nasdaq: PHAR) will report preliminary unaudited fourth quarter and full year 2025 financial results and provide a business update on March 12, 2026. Management will host a conference call and webcast at 13:30 CET / 08:30 EDT. Registration links and replay access are provided; only dial-in attendees can ask questions.
Pharming Group (PHARM) will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference virtually on February 25-26, 2026. Management presentation by CEO Fabrice Chouraqui and CMO Anurag Relan is scheduled for February 25 at 12:40pm ET / 18:40 CET.
A live webcast and replay will be available in the company’s Upcoming Events and News sections. One-on-one investor meetings can be arranged via investor@pharming.com or through Oppenheimer representatives.
Pharming (PHARM) provided 2026 financial guidance and detailed its rare disease pipeline at Investor Day on February 3, 2026. The company guided 2026 revenue of US$405–425 million (8%–13% growth) and operating expenses of US$330–335 million, citing higher R&D for leniolisib and napazimone (KL1333).
Management highlighted leniolisib Phase II top‑line readouts due H2 2026 and the napazimone (KL1333) pivotal FALCON trial on track for a 2027 readout, plus continued commercial growth for Joenja and RUCONEST.
Pharming Group (Euronext: PHARM; Nasdaq: PHAR) received a U.S. FDA Complete Response Letter (CRL) for the sNDA seeking approval of Joenja (leniolisib) for children aged 4–11 with APDS due to potential underexposure in lower-weight pediatric patients and an analytical batch-testing method issue.
Pharming plans a Type A meeting with the FDA and says the approved indication for patients 12 and older remains unaffected; the sNDA was based on positive Phase III data showing lymphadenopathy reduction and naive B cell increases.
Pharming (PHARM) reported preliminary, unaudited 2025 revenues of approximately US$376 million, above its upwardly revised guidance of US$365–375 million and representing about 27% growth vs 2024. Full‑year 2025 operating expenses are expected to be within the previously communicated US$304–308 million range. The company will host a virtual Investor Day on February 3, 2026 at 10:00 am EST to present 2026 financial guidance and pipeline updates, including leniolisib (Phase II) for PIDs with immune dysregulation and KL1333 in the pivotal FALCON study for mtDNA-driven mitochondrial disease. Pharming plans to release audited Q4 and full‑year 2025 results on March 12, 2026. Preliminary figures may change on final reporting.
Pharming (PHARM) will participate in the Oppenheimer Movers in Rare Disease Summit on December 11, 2025 in New York City.
Anurag Relan, M.D., Chief Medical Officer, will join a fireside chat on the hereditary angioedema (HAE) market at 1:50 pm ET / 19:50 CET. The event is invitation-only and gathers companies and investors focused on rare diseases. One-on-one meetings with Pharming management can be requested via investor@pharming.com or through an Oppenheimer representative.