Pharming Group N.V.
PHARNext catalyst
Leniolisib
PIDs Linked to PI3K
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Plus 1 more upcoming event in our data (Phase 2 readout).See the timeline
3 upcoming, 3 past
Leniolisib Phase 3 Est. Readout
Primary completion for Leniolisib trial (NCT05438407) in APDS
SourceFDA PDUFA Date Joenja (leniolisib) (priority)
For activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg. sNDA filing. Extracted from SEC filing: 6-K
MHRA approved extension of Joenja marketing authorization to children aged 4-11 weighing at least 27 kg with APDS; 40 mg and 50 mg twice-daily dosing; first treatment specifically approved for children with APDS in the U.K.; expected availability in February 2027.
SourceKL1333 Phase 2 Est. Readout (FALCON)
Estimated primary completion for KL1333 trial (NCT05650229) in Primary Mitochondrial Disease. Topline data typically follows completion by weeks to months.
SourceHow PHAR's past catalysts played out
Market Overview
Stock performance and key metrics
i.v. recombinant human C1 inhibitor
Genetic Disorders
recombinant human C1 inhibitor
Hereditary Angioedema
rhC1INH
Hereditary Angioedema
Leniolisib
PIDs Linked to PI3K
NaCl)
Acute Ischemic Stroke
Ruconest
Confirmed Coronavirus Disease
Sodium chloride
Acute Kidney Injury
KL1333
Primary Mitochondrial Disease
Napazimone
Mitochondrial Diseases
Conestat alfa (Ruconest®)
Acute Ischemic Stroke
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
i.v. recombinant human C1 inhibitor | Phase 3 | Genetic Disorders | - | - |
recombinant human C1 inhibitor | Phase 3 | Hereditary Angioedema | - | - |
rhC1INH | Phase 3 | Hereditary Angioedema | - | - |
Leniolisib | Phase 3 | PIDs Linked to PI3K | - | - |
NaCl) | Phase 2 | Acute Ischemic Stroke | - | - |
Ruconest | Phase 2 | Confirmed Coronavirus Disease | - | - |
Sodium chloride | Phase 2 | Acute Kidney Injury | - | - |
KL1333 | Phase 2 | Primary Mitochondrial Disease | - | - |
Napazimone | Phase 2 | Mitochondrial Diseases | - | - |
Conestat alfa (Ruconest®) | Phase 2 | Acute Ischemic Stroke | - | - |
Frequently asked questions
What is in Pharming Group N.V.'s drug pipeline?→
CatalystAlert tracks 10 drug candidates in Pharming Group N.V.'s (PHAR) pipeline across Phase 3, Phase 2. Its lead program is Leniolisib (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Pharming Group N.V.'s next FDA catalyst?→
Pharming Group N.V.'s (PHAR) next tracked catalyst is a Phase 3 readout expected November 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track PHAR biotech catalysts?→
Add PHAR to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Pharming Group N.V.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.