Pharming announces first patient enrolled in Phase III clinical trial of leniolisib for the treatment of APDS in Japan
Single-arm Phase III study in Japan evaluating leniolisib in patients aged 12 years and older with APDS, a rare primary immunodeficiency LEIDEN, The Netherlands, Aug. 9, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that...
Pharming announces the first commercial shipments of Joenja® (leniolisib) to patients in the U.S.
LEIDEN, Netherlands, April 11, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming") (Euronext Amsterdam: PHARM) (Nasdaq: PHAR) announces the first commercial shipments of Joenja® (leniolisib) to patients inthe United States. Joenja®, an oral, selective PI3Kδ inhibitor, is the first and only trea...
Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS
APDS (activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome) is a rare and progressive primary immunodeficiency Joenja® is a targeted treatment of APDS for adult and pediatric patients 12 years of age and older Joenja® is expected to launch in the US in early April Pharming will host a con...
Pharming announces first patient enrolled in pediatric clinical trial of leniolisib
The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency LEIDEN, Netherlands, Feb. 21, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces t...
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
EMA Marketing Authorisation Application for leniolisib changed to standard review timetable LEIDEN, Netherlands, Feb. 16, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency's (EMA) Committ...
Pharming announces positive interim analysis data from open-label extension study of leniolisib in presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition
V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Ph...
Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH's Blood
Leniolisib was well tolerated and significant improvement over placebo was notable in the co-primary endpoints, reflecting a favorable impact on patients' immune dysregulation and deficiency The peer-reviewed publication heightens international understanding of APDS, a rare and recently characte...
Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib
Marketing authorisation in the European Economic Area anticipated in H1 2023 LEIDEN, Netherlands, Oct. 28, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leni...
Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib
Application is based on randomized, controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency This submission follows the grant of accelerated assessment allowing an expedited review for leniolisib from a standard 210 days to 150 days LEIDEN...
Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
The FDA has assigned a PDUFA goal date of March 29, 2023 for the NDA submission based on randomized-controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency LEIDEN, The Netherlands, Sept. 28, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharmi...
Pharming Announces New ICD-10-CM Code for APDS, a Rare Primary Immunodeficiency
Implemented by the Centers for Disease Control and Prevention, the diagnosis code will accurately identify US patients with APDS, supporting care and research efforts LEIDEN, Netherlands, Aug. 2, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Na...
Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS
EMA accelerated assessment allows a shorter review period for leniolisib from a standard 210 days to 150 days Pharming is on track to submit its Marketing Authorisation Application for leniolisib in H2 2022 LEIDEN, the Netherlands, Aug. 1, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or...
Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting
LEIDEN, Netherlands, April 1, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces new data from the pivotal Phase II/III trial of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)...
