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    PHARM   NL0010391025

PHARMING GROUP N.V.

(PHARM)
  Report
Real-time Euronext Amsterdam  -  11:35:01 2023-02-02 am EST
1.236 EUR   -0.08%
01/18Pharming N : Bank of America Corporation - Pharming Group N.V. - Leiden
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01/17Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
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01/12Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
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Pharming Group N.V. Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

09/28/2022 | 01:00am EST

Pharming Group N.V. announced 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 (PI3Kd) inhibitor, to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older in the US. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 29, 2023, aligned with a Priority Review classification. Submitted by Pharming on July 29, 2022, the NDA was supported by positive data from a Phase II/III study of leniolisib, which met its co-primary endpoints of reduction in index lymph node size and correction of immunodeficiency in the target population. Those results demonstrated the efficacy of leniolisib over placebo with a statistically significant reduction from the baseline size of participants' index lymphadenopathy lesions (p=0.006) and normalization of their immune function, as evidenced by an increased proportion of naïve B cells from the baseline (p=0.002).

Those findings indicate a reduction in disease markers associated with APDS, whose clinical hallmarks include significant lymphoproliferation and immune dysfunction, as well as increased risk of lymphoma. Furthermore, safety data from the study showed that leniolisib was well tolerated by participants. Also submitted as part of the application were data from a long-term, open-label extension clinical trial including 38 patients with APDS who were treated with leniolisib for a median of 102 weeks.


ę S&P Capital IQ 2022
All news about PHARMING GROUP N.V.
01/18Pharming N : Bank of America Corporation - Pharming Group N.V. - Leiden
PU
01/17Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
PU
01/12Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
PU
2022Pharming announces positive interim analysis data from open-label extension study of le..
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2022Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
PU
2022Pharming announces positive interim analysis data from open-label extension study of le..
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2022Pharming Group N.V. Announces Positive Interim Analysis Data from Open-Label Extension ..
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2022Pharming announces publication of data from Phase 3 Study of leniolisib in patients wit..
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2022Pharming Group N.V. Announces Positive Results of Phase 3 Clinical Trial of Investigati..
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2022Pharming N : BlackRock Inc. - Pharming Group N.V. - Leiden
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Financials
Sales 2022 199 M 218 M 218 M
Net income 2022 30,3 M 33,0 M 33,0 M
Net cash 2022 91,2 M 99,6 M 99,6 M
P/E ratio 2022 -
Yield 2022 -
Capitalization 807 M 882 M 881 M
EV / Sales 2022 3,59x
EV / Sales 2023 3,05x
Nbr of Employees 277
Free-Float 98,1%
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Mean consensus BUY
Number of Analysts 2
Last Close Price 1,24 €
Average target price 1,78 €
Spread / Average Target 43,9%
EPS Revisions
Managers and Directors
Sijmen de Vries Chairman-Management Board, CEO & CFO
Jeroen Henk Wakkerman Chief Financial Officer
Paul Jai Sekhri Chairman
Anurag Relan Chief Medical Officer
Robert Friesen Chief Scientific Officer
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