Pharming Group N.V.

Aug 13, 2026

PHARFDA Updates

Pharming announces commercial launch of Joenja (leniolisib) in Japan for adult and pediatric patients with APDS aged 4 and older

Pharming Group has launched Joenja (leniolisib) in Japan for patients aged 4 and older with activated PI3K delta syndrome (APDS). This marks the first commercial availability of Joenja for children aged 4 to 11 globally. The launch follows its approval by Japan's Ministry of Health and highlights Pharming's commitment to rare disease treatment.

Aug 4, 2026

Pharming Group to participate in Canaccord Genuity 46th Annual Growth Conference

Pharming Group N.V. will participate in the Canaccord Genuity 46th Annual Growth Conference in Boston on August 12-13, 2026. Michael Levitan, VP of Investor Relations, will lead a Fireside Chat Q&A session on August 12. The company invites interested parties to schedule meetings with its management team during the conference.

Jul 30, 2026

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Pharming reports second quarter and first half 2026 financial results and revises year-end guidance; strong Joenja momentum and near-term clinical readouts to support broader therapeutic use

Pharming Group N.V. reported a 3% decrease in total revenues for Q2 2026, totaling $90.2 million. While RUCONEST revenue fell by 10%, Joenja saw a significant 40% increase. The company revised its revenue guidance downward but remains optimistic about the growth potential of Joenja and upcoming clinical data readouts. Pharming is also focusing on operational efficiency and expanding its rare disease portfolio.

Jul 16, 2026

Pharming Group to report second quarter and first half 2026 financial results and provide business update on July 30

Pharming Group N.V. will report its preliminary financial results for the second quarter and first half of 2026 on July 30, 2026. The company will also provide a business update during a conference call and webcast scheduled for the same day. Interested participants must register in advance to access the call.

Jun 4, 2026

PHARFDA Updates

Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS

Pharming Group announced the FDA's acceptance of its resubmitted supplemental New Drug Application for Joenja (leniolisib) to treat children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS). If approved, Joenja will be the first treatment for this rare immunodeficiency in the U.S. The resubmission includes additional data requested by the FDA and has a target action date of October 24, 2026.

Jun 2, 2026

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Pharming Group N.V. has announced it will release its preliminary financial results for Q4 and the full year 2025 on March 12, 2026. The company will also provide a business update during a conference call and webcast scheduled for the same day. This event underscores Pharming's commitment to transparency and investor engagement.

Feb 17, 2026

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Pharming Group to present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference

Pharming Group N.V. will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026. CEO Fabrice Chouraqui and CMO Anurag Relan will present on February 25. A live webcast of the presentation will be available on Pharming's website, and investors can schedule one-on-one meetings with management.

Feb 3, 2026

Pharming Group announces 2026 financial guidance and highlights rare disease pipeline at Investor Day

Pharming Group N.V. has announced its 2026 financial guidance, projecting revenues between $405 million and $425 million. The company will highlight its rare disease pipeline at an upcoming Investor Day, focusing on two key programs: leniolisib for primary immunodeficiencies and napazimone for mitochondrial diseases. Both programs are supported by ongoing clinical trials and aim to address significant unmet medical needs.

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Feb 2, 2026

PHARFDA Updates

Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja® (leniolisib) in children aged 4 to 11 years with APDS

Pharming Group received a Complete Response Letter from the FDA regarding its supplemental New Drug Application for Joenja (leniolisib) in children aged 4 to 11 with activated phosphoinositide 3-kinase delta syndrome (APDS). The FDA raised concerns about potential underexposure in lower weight patients and requested additional pharmacokinetic data. Despite this setback, Pharming aims to address the FDA's issues and plans to request a Type A meeting to discuss resubmission.

Jan 8, 2026

Pharming Group appoints Kenneth Lynard as Chief Financial Officer

Pharming Group N.V. has appointed Kenneth Lynard as Chief Financial Officer, effective October 1, 2025. Lynard, a seasoned finance executive with over 20 years of experience in the life sciences sector, is expected to enhance Pharming's financial leadership amid strong growth. His previous roles include CFO positions at notable companies, including Gilead Sciences.

Aug 4, 2025

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Pharming Group to participate in August investor conference

Pharming Group N.V. has announced its participation in an investor conference scheduled for August. The company's management will be available for one-to-one meetings, highlighting their commitment to investor engagement. Pharming is focused on developing innovative medicines for patients with rare and life-threatening diseases.

Jul 31, 2025

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Pharming Group reports second quarter and first half 2025 financial results and provides business update

Pharming Group announced its financial results for the second quarter and first half of 2025, reporting a 26% increase in total revenues to US$93.2 million. Key revenue drivers included strong sales growth from RUCONEST® and Joenja®, with respective revenues of US$80.4 million and US$12.8 million. The company has raised its revenue guidance for the year, bolstered by recent developments including a new drug application for Joenja® in Japan. Additionally, a study highlights the potential for a significant increase in the prevalence of APDS, presenting new opportunities for patient growth.

Jul 17, 2025

Pharming Group to report second quarter and first half 2025 financial results and provide business update on July 31

Pharming Group N.V. has announced that it will report its preliminary financial results for the second quarter and first half of 2025 on July 31, 2025. In addition to the financial updates, the company will provide a business update during a conference call and webcast scheduled for the same day. The event aims to engage analysts and investors and will include an opportunity for dial-in attendees to ask questions. Pharming is dedicated to developing innovative medicines for patients with rare and serious illnesses.

Jun 24, 2025

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Pharming Group N.V. reported a robust first quarter for 2025, with total revenues climbing to US$79.1 million, an impressive 42% year-over-year increase. The company's flagship product, RUCONEST®, reported a 49% growth in revenue, driven by strong demand in the U.S. market. Joenja® (leniolisib) also experienced positive momentum with an 18% increase in volume. However, the departure of CFO Jeroen Wakkerman raises concerns about future financial leadership as the company prepares for a filing for pediatric FDA approval.

Apr 30, 2025

Pharming Group announces the 2025 Annual General Meeting of Shareholders and the nomination of a new Non-Executive Director

Pharming Group N.V. has announced its 2025 Annual General Meeting of Shareholders scheduled for June 11, featuring the nomination of Dr. Elaine Sullivan as a new Non-Executive Director. Alongside this, current directors Deborah Jorn and Steven Baert will not seek reappointment. The agenda also includes reappointments of existing directors and a proposal to renew share issuance and repurchase authorizations. The AGM will take place at the Corpus Congress Centre in Oegstgeest, Netherlands, and will be webcast live.

Apr 25, 2025

Pharming Group announces upcoming presentations at the 2025 Annual Meeting of the Clinical Immunology Society (CIS)

Pharming Group N.V. announced its upcoming presentations at the 2025 Annual Meeting of the Clinical Immunology Society, showcasing Phase III clinical data for leniolisib in pediatric patients with activated PI3Kδ syndrome. Presenters will include experts from notable institutions, and several topics on immune dysregulation and immunodeficiencies will be discussed. While leniolisib has been approved for older patients, its efficacy in younger children remains unverified by regulatory bodies, and there are cautions regarding the translation of preclinical data to clinical outcomes.

Apr 24, 2025

Pharming Technologies B.V. has declared its cash offer for Abliva AB unconditional after receiving acceptance for approximately 87.7% of the shares. The acceptance period has been extended until February 20, 2025, to allow remaining shareholders to participate. Pharming will complete the acquisition and expects settlement for the accepted shares to begin around February 14, 2025. Additionally, Pharming plans to initiate a compulsory acquisition procedure if it acquires more than 90% of the shares.

Jan 21, 2025

Pharming Group announces the repurchase of outstanding €125 million convertible bonds due 2025

Pharming Group N.V. has announced the successful repurchase of €123.1 million of its 3.00% senior unsecured convertible bonds due 2025, equating to 98.5% of the total outstanding amount. The final settlement date for this repurchase is anticipated on April 26, 2024. The move supports Pharming's financial strategy, potentially allowing for early redemption of the remaining bonds if certain conditions are met. This action reflects the company's ongoing efforts in managing its debt and improving its financial position.

Apr 18, 2024

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Pharming Group announces the placement of €100 million convertible bonds due 2029

Pharming Group N.V. has successfully placed €100 million in senior unsecured convertible bonds due 2029, fully subscribed through an accelerated book-building process. The funds will be utilized to repurchase existing convertible bonds due 2025, thus strengthening the company's financial position. The new bonds will carry a 4.50% annual coupon and are expected to start trading on the Frankfurt Stock Exchange following issuance. The company aims to enhance its flexibility for ongoing business strategies in the coming years.

Pharming Group N.V. has announced that it will report its preliminary fourth quarter and full year 2023 financial results on March 14, 2024. The company plans to host a presentation for analysts and investors, facilitating an interactive session through a conference call. This event reflects Pharming's ongoing commitment to transparency and engagement with stakeholders in the biopharmaceutical industry.

Feb 8, 2024

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Pharming Group to participate in February investor conferences

Pharming Group N.V. announced its participation in two investor conferences in February 2024. CEO Sijmen de Vries will present at the Oppenheimer 34th Annual Healthcare Life Sciences Virtual Conference on February 13, followed by participation in the UBS European Healthcare Conference in London on February 28. The events provide an opportunity for investors to engage with the company's management and learn about Pharming's innovative biopharmaceutical portfolio.

Jan 8, 2024

Pharming Group announces updated full year 2023 guidance and Joenja U.S. launch update

Pharming Group N.V. has announced updated guidance for full year 2023, predicting a revenue increase of 19% to about US$245 million, driven by significant growth in RUCONEST® and Joenja® therapies. The company expects RUCONEST® revenues to grow by 10% and Joenja® revenues to reach around US$18 million. Additionally, there has been an increase in new patient enrollments contributing to the positive financial outlook, alongside the successful launch of Joenja® in the U.S. market. Pharming aims to expand its product offerings and market presence, anticipating further developments in rare disease therapies in the coming years.

Dec 13, 2023

PHARPhases

Pharming Group announces development plans for leniolisib for additional primary immunodeficiencies (PIDs)

Pharming Group N.V. has announced plans to develop leniolisib for additional primary immunodeficiencies (PIDs) beyond activated phosphoinositide 3-kinase delta syndrome (APDS). The company plans to initiate a Phase 2 clinical trial in the second quarter of 2024, focusing on PIDs linked to immune dysregulation associated with PI3Kδ signaling. The trial aims to assess safety, tolerability, pharmacokinetics, and clinical efficacy in about 12 patients. This development is notable as it seeks to address the lack of approved therapies for these rare genetic disorders.

Nov 21, 2023

PHARPhases

Pharming announces first patient dosed in pediatric clinical trial for children aged 1 to 6 years for leniolisib

Pharming Group N.V. has dosed its first patient in a Phase III clinical trial aimed at evaluating a new pediatric formulation of leniolisib for children aged 1 to 6 years with activated phosphoinositide 3-kinase delta syndrome (APDS). The trial will assess the safety, tolerability, and efficacy in 15 young patients. This initiative reflects Pharming's commitment to expanding treatment options for pediatric patients suffering from this rare immunodeficiency disorder. Leniolisib is already approved for older patients and aims to provide significant benefits for younger patients, improving their overall participation in typical childhood activities.

Pharming Group provides updates on EMA regulatory review of leniolisib MAA and plans to file for UK regulatory approval

Pharming Group N.V. has announced updates regarding its Marketing Authorization Application (MAA) for leniolisib, a treatment for Activated Phosphoinositide 3-Kinase δ Syndrome (APDS). The European Medicines Agency (EMA) has issued a Day 180 Second List of Outstanding Issues, with a decision expected in the first quarter of 2024. In addition, Pharming intends to submit an MAA to the UK's MHRA through the International Recognition Procedure following the approval already granted by the US FDA. Leniolisib has shown clinical efficacy and is currently under regulatory review in multiple regions.

Nov 7, 2023

Pharming Group announces presentations at International Primary Immunodeficiencies Congress and the American College of Allergy, Asthma & Immunology Annual Scientific Meeting

Pharming Group N.V. announced that it will showcase 14 poster presentations at the International Primary Immunodeficiencies Congress and the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in November 2023. The presentations primarily focus on leniolisib, an innovative treatment for activated phosphoinositide 3-kinase delta syndrome. Key findings will discuss the long-term efficacy and safety of leniolisib, along with its impacts on patient quality of life. This highlights Pharming's commitment to addressing rare and complex diseases in global healthcare settings.

Nov 1, 2023

Pharming Group to participate in November investor conferences

Pharming Group N.V. is set to participate in several investor conferences this November, including the Stifel 2023 Healthcare Conference and the Jefferies London Healthcare Conference. Key company executives, including the Chief Medical Officer and CEO, are scheduled to present and engage in discussions. This involvement indicates Pharming's efforts to strengthen investor relations and highlight its developments in biopharmaceuticals. Interested parties can schedule one-on-one meetings with the management team during these events.

Pharming Group reports third quarter 2023 financial results

Pharming Group reported a robust financial performance for Q3 2023, with revenues increasing by 23% to $66.7 million, primarily driven by strong sales of RUCONEST® and the successful commercial launch of Joenja®. The company highlighted a total revenue of $164.1 million for the first nine months of 2023, marking a 9% increase year-over-year. However, revenue growth for RUCONEST® is projected to remain modest, and the company continues to focus on enhancing patient access and diagnosis strategies. Pharming is also progressing on regulatory submissions for Joenja® in various countries.

Oct 12, 2023

Pharming Group to report third quarter 2023 financial results on October 26

Pharming Group N.V. has announced it will release its preliminary third quarter 2023 financial results on October 26, 2023. A conference call will be held at 13:30 CEST/07:30 EDT the same day, with advance registration required for participants. The company continues to support patients with rare diseases through its portfolio of protein replacement therapies and precision medicines, operating in over 30 global markets.

Sep 25, 2023

Pharming Group reports on results of the 2023 Extraordinary General Meeting of Shareholders

Pharming Group N.V. reported that all proposals from its 2023 Extraordinary General Meeting of Shareholders were adopted. Key highlights include the appointment of Dr. Richard Peters as the new Non-Executive Director, succeeding Paul Sekhri as Chair of the Board. The leadership transition marks a continuation of Pharming's strategic objectives focused on growth in the rare disease market. Shareholders also approved a proposal for an annual fee increase for the Board Chair, reinforcing confidence in the company's governance.

Aug 24, 2023

LEIDEN, The Netherlands, March 24, 2005 (PRIMEZONE) -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext:PHARM) (PHAR.AS) (Other OTC:PHGUF) announced today that the Company has been included in the Next 150 Index on the stock exchange of Euronext N.V. (Euronext). The N