Pharming Group

Pharming Group NV is a holding company, which engages in the development of pharmaceutical products for the treatment of rare diseases and unmet medical needs. The firm offers RUCONEST, which is a recombinant human C1-esterase inhibitor for the treatment of acute hereditary angioedema. It operates through the following geographical segments: the United States, Europe, and Rest of the World. The company was founded on November 11, 1988 and is headquartered in Leiden, the Netherlands.

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Pharming Group NV is a holding company, which engages in the development of pharmaceutical products for the treatment of rare diseases and unmet medical needs. The firm offers RUCONEST, which is a recombinant human C1-esterase inhibitor for the treatment of acute hereditary angioedema. It operates through the following segments: RUCONEST®, Joenja®, Europe, and Rest of the World. The company was founded on November 11, 1988, and is headquartered in Leiden, the Netherlands.

FDA approval and commercial launch of Joenja® (leniolisib) in the U.S. Joenja® launch off to strong start with 23 U.S. patients on paid therapy Revenues decreased by 9% to US$42.5 million, compared to the first quarter of 2022, primarily due to temporary reimbursement disruptions for some patients on government insurance programs. This issue, affecting all of the HAE market, has since resolved Continue to anticipate low single digit growth in annual revenues from RUCONEST® in 2023 Continued significant investments made in leniolisib launch preparations and organizational structure Overall cash balance of US$184.8 million at the end of the quarter LEIDEN, Netherlands , May 11, 2023 /PRNewswire/ -- Pharming Group N.V.

Pharming Group reports financial results for the first quarter of 2023

Pharming Group N.V. Sponsored ADR (PHAR) witnessed a jump in share price last session on above-average trading volume.

Strength Seen in Pharming Group N.V. Sponsored ADR (PHAR): Can Its 5.2% Jump Turn into More Strength?

Pharming Group N.V. is a Dutch company with two products in the market. However, despite having one product for 8 years now, the company has not managed to get its cash flow in order.

Pharming Group: Small Company, Unclear Management Style, Low Volume

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 in the United States.

Pharming announces the first commercial shipments of Joenja® (leniolisib) to patients in the U.S.

LEIDEN, The Netherlands , March 30, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming") (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announces that Pharming's Chief Executive Officer, Sijmen de Vries, and Chief Commercial Officer, Stephen Toor, will attend the Guggenheim Healthcare Talks | Genomic Medicines and Rare Disease Days, April 3 - 4, 2023 in New York.

Pharming to present at the Guggenheim Healthcare Talks - Genomic Medicines and Rare Disease Days

Pharming Group (PHAR) obtains FDA approval for leniolisib for the treatment of a rare pediatric disease. The stock of the company is up about 33% following the same.

Pharming (PHAR) Rare Disease Drug Joenja Gets FDA Nod, Stock Up

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 conference call for investors and analysts on March 27 at 14:00 CEST/08:00 EST LEIDEN, The Netherlands , March 24, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved 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.

Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS

Pharming Group N.V. (OTCPK:PHGUF) Q4 2022 Earnings Call Transcript March 16, 2023 8:30 AM ET Company Participants Sijmen de Vries - Executive Director & Chief Executive Officer Anurag Relan - Chief Medical Officer Jeroen Wakkerman - Chief Financial Officer Stephen Toor - Chief Commercial Officer & General Manager Americas Conference Call Participants Sushila Hernandez - Kempen Joe Pantginis - H.C.

Pharming Group N.V. (PHGUF) Q4 2022 Earnings Call Transcript

Pharming Group (PHAR) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Pharming Group (PHAR)

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 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 (PI3Kδ) inhibitor, in children with activated phosphoinositide 3-kinase delta syndrome (APDS).

Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

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) 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.

Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

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Pharming Group N.V. Sponsored ADR (PHAR) is on the Move, Here's Why the Trend Could be Sustainable

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 Phase II/III randomized, controlled trial LEIDEN, Netherlands , Dec. 15, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces data, including new evidence, from an interim analysis of its open-label extension study evaluating the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.

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

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 characterized immunodeficiency LEIDEN, Netherlands , Dec. 7, 2022 /PRNewswire/ --  Pharming 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 drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, have been published in Blood,1 the peer-reviewed international medical journal of the American Society of Hematology.

Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH's Blood

Here is how Pharming Group N.V. Sponsored ADR (PHAR) and POINT Biopharma Global Inc. (PNT) have performed compared to their sector so far this year.

Has Pharming Group (PHAR) Outpaced Other Medical Stocks This Year?

Recent Price Trend in Pharming Group N.V. Sponsored ADR (PHAR) is Your Friend, Here's Why

Presentation to highlight data from the ongoing long-term open-label extension study of leniolisib, a PI3Kδ inhibitor under investigation for APDS, a rare primary immunodeficiency LEIDEN, Netherlands , Nov. 23, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces today that new clinical data for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, an investigational treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, will be presented by V.

Pharming Group announces presentation of new leniolisib data at 2022 ASH Annual Meeting

Pharming Group N.V. Sponsored ADR (PHAR) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.

Can Pharming Group N.V. Sponsored ADR (PHAR) Run Higher on Rising Earnings Estimates?

Pharming Group N.V. (OTCPK:PHGUF) Q3 2022 Earnings Conference Call October 27, 2022 7:30 AM ET Company Participants Sijmen de Vries - Chief Executive Officer Anurag Relan - Chief Medical Officer Jeroen Wakkerman - Chief Financial Officer Conference Call Participants Hartaj Singh - Oppenheimer & Co. Joseph Pantginis - H.C.

Pharming Group N.V. (PHGUF) Q3 2022 Earnings Call Transcript

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 leniolisib has been validated for scientific evaluation under an accelerated assessment by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment 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, Netherlands , Oct. 11, 2022 /PRNewswire/ -- Pharming 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 Medicines Agency (EMA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents 12 years or older.

Pharming submits a Marketing Authorisation Application to the European Medicines Agency 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.

Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

LEIDEN, The Netherlands , Sept. 7, 2022 /PRNewswire/ -- Pharming Group N.V.

CEO of Pharming to present at H.C. Wainwright 24th Annual Global Investment Conference

Pharming Group N.V. (OTCPK:PHGUF) First Half 2022 Earnings Conference Call August 4, 2022 7:30 AM ET Company Participants Sijmen de Vries – Chief Executive Officer Anurag Relan – Chief Medical Officer Jeroen Wakkerman – Chief Financial Officer Conference Call Participants Joe Pantginis – H.C.

Pharming Group N.V.'s (PHGUF) CEO Sijmen de Vries on First Half 2022 Results - Earnings Call Transcript

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/Nasdaq: PHAR) announces that a new diagnosis code for reporting cases of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, will be added to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) by the US Centers for Disease Control and Prevention (CDC).

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