Frankfurt:PHGN

Pharming Group announces that it expects to have full access today to its cash on deposit at Silicon Valley Bank in light of US Government announcement

Retrieved on: 
Monday, March 13, 2023
Federal Deposit Insurance Corporation, Federal Reserve, Pharming, SVB, Silicon, Euronext Amsterdam, Bloomberg L.P. v. Board of Governors of the Federal Reserve System, FDIC, Silicon Valley Bank, Treasury, Structure of the Federal Reserve System, Bank

LEIDEN, Netherlands, March 13, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) is aware that the US Department of the Treasury, the Board of Governors of the Federal Reserve System and the Federal Deposit Insurance Corporation ("FDIC") issued a joint statement on March 12, 2023 stating that actions have been approved enabling the FDIC to complete its resolution of Silicon Valley Bank ("SVB US") in a manner that fully protects all depositors.

Key Points: 
  • LEIDEN, Netherlands, March 13, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) is aware that the US Department of the Treasury, the Board of Governors of the Federal Reserve System and the Federal Deposit Insurance Corporation ("FDIC") issued a joint statement on March 12, 2023 stating that actions have been approved enabling the FDIC to complete its resolution of Silicon Valley Bank ("SVB US") in a manner that fully protects all depositors.
  • The statement further noted that depositors will have access to all of their money starting today.
  • As a result of these actions, Pharming expects to have access to the US$26 million it has on deposit at SVB US, and to not bear any losses on these deposits.
  • Pharming continues to actively monitor the situation, including with respect to its US$19 million in deposits at Silicon Valley Bank UK Limited.

Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

Retrieved on: 
Tuesday, February 21, 2023
APDS, New Drug Application, American Society of Hematology, Rheumatology, Ageing, CHMP, MAA, Diagnosis, MHRA, PDUFA, Safety, Division, Patient, HIV disease progression rates, Committee, Clinical trial, PASLI disease, EMA, Food, Committee for Medicinal Products for Human Use, European Medicines Agency, Index, Health care, Disease, FDA, MPH, Phase, Society, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Directive on Traditional Herbal Medicinal Products, Prescription Drug User Fee Act, PIP, UCLA, Marketing Authorisation Application, Doctor of Philosophy, Vaccine, Pharmaceutical industry, Pharming, MD

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). There is currently no approved treatment for this complex and progressive disease caused by genetic variants.

Key Points: 
  • Pharming plans to initiate a similar clinical trial in the third quarter of 2023 that will include children aged 1 to 6 years, with APDS, to evaluate a new pediatric formulation of leniolisib.
  • Eligible patients enrolled in either of the pediatric trials will continue to receive leniolisib for a year after the initial 12-week treatment period through an open-label extension trial.
  • Anurag Relan, MD, MPH, Chief Medical Officer of Pharming, commented:
    "I am pleased we have initiated the first trial in our Phase III pediatric clinical program evaluating leniolisib in children with APDS, and I look forward to our second pediatric trial getting underway.
  • Pharming expects that the CHMP will issue its opinion on the leniolisib MAA in 2H 2023.

Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

Retrieved on: 
Tuesday, February 21, 2023
APDS, New Drug Application, American Society of Hematology, Rheumatology, Ageing, CHMP, MAA, Diagnosis, MHRA, PDUFA, Safety, Division, Patient, HIV disease progression rates, Committee, Clinical trial, PASLI disease, EMA, Food, Committee for Medicinal Products for Human Use, European Medicines Agency, Index, Health care, Disease, FDA, MPH, Phase, Society, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Directive on Traditional Herbal Medicinal Products, Prescription Drug User Fee Act, PIP, UCLA, Marketing Authorisation Application, Doctor of Philosophy, Vaccine, Pharmaceutical industry, Pharming, MD

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). There is currently no approved treatment for this complex and progressive disease caused by genetic variants.

Key Points: 
  • Pharming plans to initiate a similar clinical trial in the third quarter of 2023 that will include children aged 1 to 6 years, with APDS, to evaluate a new pediatric formulation of leniolisib.
  • Eligible patients enrolled in either of the pediatric trials will continue to receive leniolisib for a year after the initial 12-week treatment period through an open-label extension trial.
  • Anurag Relan, MD, MPH, Chief Medical Officer of Pharming, commented:
    "I am pleased we have initiated the first trial in our Phase III pediatric clinical program evaluating leniolisib in children with APDS, and I look forward to our second pediatric trial getting underway.
  • Pharming expects that the CHMP will issue its opinion on the leniolisib MAA in 2H 2023.

Pharming to present at Jefferies Healthcare Conference

Retrieved on: 
Thursday, November 3, 2022
Patient, Conference, CEO, Euronext Amsterdam, Investor relations, Jefferies, Pharmaceutical industry, Pharming

LEIDEN, Netherlands, Nov. 3, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming") (Euronext Amsterdam: PHARM) (Nasdaq: PHAR) announces that its Chief Executive Officer, Sijmen de Vries, will present at the Jefferies Healthcare Conference in London, November 15-17, 2022.

Key Points: 
  • LEIDEN, Netherlands, Nov. 3, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming") (Euronext Amsterdam: PHARM) (Nasdaq: PHAR) announces that its Chief Executive Officer, Sijmen de Vries, will present at the Jefferies Healthcare Conference in London, November 15-17, 2022.
  • Pharming Group N.V.'s CEO will present on Tuesday, November 15 at 09:45 GMT / 10:45 CET.
  • For more information about the conference, or to schedule a one-to-one with Pharming's management team, please contact your Jefferies representative, or send an email to Pharming's Investor Relations team to [email protected] .
  • Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases.

Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Retrieved on: 
Friday, October 28, 2022
Gene, Phase, MAA, PIK3R1, U.S. Securities and Exchange Commission, Company, Attention deficit hyperactivity disorder predominantly inattentive, Primary immunodeficiency, Marketing, Safety, Disclosure, Forward-looking statement, Goal, B cell, PDK1, PIP2, AKT, PIK3CD, European Economic Area, Cell, Immunodeficiency, Committee, PI3K, European Medicines Agency, Macrophage, MPH, Growth hacking, Genetic testing, Metabolism, Annual report, Patient, Phrase, Immune system, APDS, Euronext Amsterdam, Committee for Medicinal Products for Human Use, Review, Autoimmunity, PIP3, CHMP, Time, Marketing Authorisation Application, Neutrophil, Advanced Therapy Medicinal Product, EMA, Public health, Vaccine, Pharmaceutical industry, MD, Pharming

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). The application, submitted earlier in October 2022, is for the investigational drug, 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 adolescents and adults 12 years or older.

Key Points: 
  • 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 ).
  • In August 2022, Pharming announced the leniolisib MAA was granted accelerated assessment by EMA's CHMP.
  • Marketing authorisation for leniolisib in the European Economic Area is anticipated in H1 2023.
  • This review constitutes a key milestone in Pharming's effort to give healthcare providers and their patients global access to leniolisib.

Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib

Retrieved on: 
Friday, October 28, 2022
Gene, Phase, MAA, PIK3R1, U.S. Securities and Exchange Commission, Company, Attention deficit hyperactivity disorder predominantly inattentive, Primary immunodeficiency, Marketing, Safety, Disclosure, Forward-looking statement, Goal, B cell, PDK1, PIP2, AKT, PIK3CD, European Economic Area, Cell, Immunodeficiency, Committee, PI3K, European Medicines Agency, Macrophage, MPH, Growth hacking, Genetic testing, Metabolism, Annual report, Patient, Phrase, Immune system, APDS, Euronext Amsterdam, Committee for Medicinal Products for Human Use, Review, Autoimmunity, PIP3, CHMP, Time, Marketing Authorisation Application, Neutrophil, Advanced Therapy Medicinal Product, EMA, Public health, Vaccine, Pharmaceutical industry, MD, Pharming

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). The application, submitted earlier in October 2022, is for the investigational drug, 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 adolescents and adults 12 years or older.

Key Points: 
  • 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 ).
  • In August 2022, Pharming announced the leniolisib MAA was granted accelerated assessment by EMA's CHMP.
  • Marketing authorisation for leniolisib in the European Economic Area is anticipated in H1 2023.
  • This review constitutes a key milestone in Pharming's effort to give healthcare providers and their patients global access to leniolisib.