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 N.V. announces that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
Leniolisib is the first treatment approved in the U.K. specifically for APDS, a rare and progressive primary immunodeficiency. It is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.
The MHRA evaluated the Marketing Authorisation Application (MAA) for leniolisib through the International Recognition Procedure (IRP) pathway based on the U.S. Food and Drug Administration (FDA) approval received in March 2023. This marks Pharming's third country approval for APDS.
Pharming Group (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced its participation in two major investor conferences in September 2024. The company will be present at the 2024 Wells Fargo Healthcare Conference in Boston from September 4-6, where CEO Sijmen de Vries will engage in a fireside chat on September 6 at 08:45 AM ET. Additionally, Pharming will attend the H.C. Wainwright 26th Annual Global Investment Conference in New York from September 9-11, with de Vries presenting on September 9 at 10:30 AM ET.
Both presentations will be available via live webcast and replay on Pharming's website. Investors interested in one-to-one meetings with Pharming's management team can contact the company's Investor Relations team or their Wells Fargo or H.C. Wainwright representatives.
Pharming Group reported a 35% increase in Q2 2024 revenues to US$74.1 million, driven by strong sales of RUCONEST® and Joenja®. RUCONEST® revenues rose 23% to US$63 million, while Joenja® increased 16% to US$11.1 million from Q1 2024. First half 2024 revenues reached US$129.7 million, up 33% from 1H 2023. The company is on track to meet its 2024 revenue guidance of US$280 million - US$295 million.
However, cash and marketable securities dropped to US$161.8 million due to convertible bond refinancing. Pharming's operating loss narrowed, but net loss was US$1.2 million in Q2 2024, down from a US$1.3 million profit in Q2 2023. The company continues to expand Joenja® availability and expects a decision from the UK MHRA in Q4 2024.
Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced it will report its preliminary (unaudited) second quarter and first half 2024 financial results on Thursday, August 1, 2024. The report will cover the period ended June 30. The company will host a presentation for analysts and investors at 13:30 CEST/07:30 am EDT on the same day.
Interested parties can participate in the conference call by registering in advance. Upon registration, dial-in information and a unique PIN will be provided for call access. The company will only take questions from dial-in attendees. Additionally, a live webcast of the presentation will be available for those who prefer to watch online. Both the conference call and webcast require pre-registration through the provided links.
Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announced its participation in three key investor conferences in June 2024. CEO Sijmen de Vries will present at the Jefferies Healthcare Conference in New York on June 5. CMO Anurag Relan will join a panel at the Oppenheimer Novel Targets in Immunology Summit on June 24. Additionally, Pharming will attend the Oppenheimer 2024 Montauk Life Sciences Summit from June 26-28. These events aim to provide investors with insights into the company's progress and future plans. Live webcasts and replays will be available on Pharming's website.
Pharming Group has provided an update on the regulatory review of leniolisib for treating APDS in the EU. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has affirmed the clinical benefit and safety of leniolisib but requested further clarification on manufacturing controls before approval.
Pharming has been granted an extension to January 2026 to fulfill these requirements. Despite the delay, leniolisib has shown positive efficacy and safety in clinical trials, meeting co-primary endpoints and benefiting patients in long-term studies. The drug is already approved in the US since March 2023. Pharming maintains its 2024 revenue guidance.
Pharming Group announced the results of its 2024 Annual General Meeting (AGM) held on May 21, 2024. All proposals were approved by shareholders, including the reappointment of Ms. Barbara Yanni and Mr. Mark Pykett as Non-Executive Directors for four years. The updated Remuneration Policy for the Board was also accepted. Additionally, shareholders authorized the Board to issue shares and/or options and to repurchase shares. Detailed information and a recording of the AGM are available on Pharming's Investor Relations webpage.
Pharming Group (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced its participation in the H.C. Wainwright 2nd Annual BioConnect Investor Conference. The event will be held at NASDAQ, New York, on May 20, 2024.
Michael Levitan, VP of Investor Relations and Corporate Communications, will deliver a presentation at 09:30 EDT/15:30 CET. Investors interested in scheduling one-to-one meetings with Pharming's management team can contact the company's Investor Relations team or their H.C. Wainwright representative.
Pharming Group has announced the early redemption of the remaining €1.9 million in 3.00% convertible bonds due 2025. Originally, €125 million in bonds were issued, but €123.1 million were repurchased by Pharming on 26 April 2024. The remaining bonds will be redeemed on 18 June 2024 at 100% of their principal amount, with accrued interest paid up to the redemption date. Bondholders have until 7 June 2024 to exercise their conversion rights at a price of €2.0028 per ordinary share. As of the latest trading session, Pharming's stock closed at €0.868.
Pharming Group N.V. reported a strong first quarter in 2024 with a 31% revenue increase to US$55.6 million driven by the U.S. launch of Joenja® and RUCONEST® growth. The company is on track to meet its 2024 revenue guidance of US$280-295 million. Pharming is actively finding more APDS patients and expanding leniolisib availability globally. Leniolisib clinical trials for pediatric and additional indications are progressing. The company refinanced convertible bonds to strengthen its financial position.
