Pharming announces first patient enrolled in pediatric clinical trial of leniolisib – Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been enrolled in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3K?) inhibitor, in children with activated
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe – Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation Application (MAA) for leniolisib to a standard review timetable. Leniolisib is an
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 – Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Phase II/III randomized, controlled trialPharming Group N.V. ("Pharming" or "the Company") (EURONEXT
Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH's Blood – The peer-reviewed publication heightens international understanding of APDS, a rare and recently characterized immunodeficiencyPharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces today that the positive results of a Phase 3 clinical trial of the investigational
Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib – Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines
Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib – This submission follows the grant of accelerated assessment allowing an expedited review for leniolisib from a standard 210 days to 150 daysPharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has submitted a Marketing Authorisation Application (MAA) to the European
Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib – Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) announces that the US Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3K?) inhibitor, to treat the rare
Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS – Pharming is on track to submit its Marketing Authorisation Application for leniolisib in H2 2022Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)
ฟาร์มิ่ง ประกาศผลสำเร็จจากการทดลองยา เลนิโอลิซิบ ระยะที่ 2/3 ในการประชุมสมาคมภูมิคุ้มกันวิทยาคลินิก ประจำปี 2565 – ตามที่ได้ประกาศเมื่อวันที่ 2 กุมภาพันธ์ 2565 การทดลองทางคลินิกระยะที่ 3 แบบนานาชาติ ควบคุมด้วยยาหลอกแบบอำพรางสามฝ่าย (Triple-blind กล่าวคือ ทั้งผู้รับการทดลอง แพทย์ และผู้ประเมินผลต่างก็ไม่ทราบว่าผู้รับการทดลองรายใดได้ยาจริงหรือยาหลอก) ดำเนินการโดยบริษัทโนวาร์ทิส (Novartis) ได้บรรลุผลลัพธ์หลักร่วม
Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting – As announced on February 2, 2022, the multinational, triple-blind, placebo-controlled, randomized, Phase III portion of the clinical trial, conducted by Novartis, met its co-primary endpoints, which evaluated reduction in lymph node size and correction of immunodeficiency. The shrinking of