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Pharming Group (PHAR)

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Recent press releases and 8-K filings for PHAR.

Pharming Group Faces Investigation Following FDA Complete Response Letter
PHAR
Legal Proceedings
Demand Weakening
  • Pomerantz LLP is investigating Pharming Group N.V. (PHAR) for potential securities fraud or other unlawful business practices.
  • This investigation follows a U.S. Food and Drug Administration (FDA) Complete Response Letter (CRL) issued on February 1, 2026, for Pharming's supplemental New Drug Application (sNDA) for Joenja®.
  • The FDA's CRL cited concerns regarding potential underexposure in lower weight pediatric patients and an issue with an analytical method used for production batch testing.
  • Following this news, Pharming's American Depositary Receipt (ADR) price fell $3.495 per ADR, or 17.07%, to close at $16.975 per ADR on February 2, 2026.
1 day ago
Pharming Group Provides 2025 Financial Performance and 2026 Guidance, Updates on Key Pipeline Assets
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming Group reported $376 million in sales for 2025, representing a 27% growth over 2024, and projects 2026 revenues to be between $405 million-$425 million, indicating 8%-13% growth.
  • The company anticipates 2026 operating expenses in the range of $330 million-$335 million, which includes $60 million in incremental R&D investments for pipeline advancement.
  • For Joenja, a supplemental NDA for pediatric use (4-11 years old) in the US received a Complete Response Letter, while EMA approval for this indication is expected in the first half of 2026.
  • Pharming expects Phase II readouts for leniolisib in new indications in the second half of 2026, and the napazimone Phase II study is projected to complete enrollment in 2026, with a readout at the end of 2027 and potential approval in 2028.
3 days ago
Pharming Group reports 2025 sales, 2026 guidance, and pipeline updates
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported $376 million in sales for 2025, marking a 27% growth over 2024, and projects 2026 revenues between $405 million-$425 million, an 8%-13% increase. Operating expenses are guided to be $304 million-$308 million for 2025 and $330 million-$335 million for 2026, including $60 million in incremental R&D investments.
  • For Joenja, a significant growth catalyst, the supplemental NDA for pediatric use (4-11 years old) in the US received a Complete Response Letter, but a Type A meeting with the FDA has been requested. EMA approval for Joenja is anticipated in March 2026.
  • The company's pipeline includes Phase II trials for leniolisib in new indications, with readouts expected in H2 2026. The napazimone (formerly KL1333) Phase 2 FALCON study for primary mitochondrial disease is on track to complete enrollment in 2026, with results expected by the end of 2027 and potential approval in 2028.
3 days ago
Pharming Group Updates on 2025 Performance, 2026 Outlook, and Pipeline Progress
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming Group reported $376 million in sales for 2025, representing 27% growth over 2024, and generated an operating profit of $30 million and operating cash flow of $44 million for the first nine months of 2025.
  • The company provided 2026 revenue guidance of $405 million-$425 million, indicating 8%-13% growth, with operating expenses projected to be $330 million-$335 million, including $60 million in incremental R&D investments.
  • For Joenja, Pharming received a Complete Response Letter (CRL) from the FDA for the supplemental NDA to expand use to pediatric patients (4-11 years old) in the U.S., but expects a March opinion from CHMP for European approval in the first half of 2026.
  • The napazimone program, targeting primary mitochondrial disease, showed positive interim analysis results in its Phase 2 FALCON study, clearing futility for both primary endpoints, with a full readout expected at the end of 2027.
3 days ago
Pharming Group Faces Investor Investigation Following FDA Complete Response Letter for Joenja®
PHAR
Legal Proceedings
  • Pomerantz LLP is investigating Pharming Group N.V. (PHAR) for potential securities fraud or unlawful business practices on behalf of investors.
  • The investigation follows Pharming's February 1, 2026, announcement of a Complete Response Letter (CRL) from the FDA for its supplemental New Drug Application (sNDA) for Joenja® (leniolisib) for pediatric use.
  • The FDA's CRL cited concerns regarding potential underexposure in lower weight pediatric patients and an issue with an analytical method used for production batch testing.
  • Following this news, Pharming's American Depositary Receipt (ADR) price fell 17.07% to close at $16.975 per ADR on February 2, 2026.
Feb 20, 2026, 1:04 AM
Pharming Group receives FDA Complete Response Letter for Joenja® sNDA
PHAR
Legal Proceedings
Product Launch
  • Pomerantz LLP is investigating Pharming Group N.V. (PHAR) for potential securities fraud or unlawful business practices.
  • This investigation follows Pharming's announcement on February 1, 2026, that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for Joenja® (leniolisib).
  • The FDA's CRL cited concerns about potential underexposure in lower weight pediatric patients and an issue with an analytical method used for production batch testing.
  • Following this news, Pharming's American Depositary Receipt (ADR) price fell 17.07% to close at $16.975 per ADR on February 2, 2026.
Feb 12, 2026, 11:42 PM
Pharming Group Faces Investigation Following FDA Letter
PHAR
Legal Proceedings
  • Pomerantz LLP is investigating Pharming Group N.V. (NASDAQ: PHAR) and its officers/directors for potential securities fraud or unlawful business practices.
  • The investigation follows Pharming's announcement on February 1, 2026, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for Joenja®.
  • The FDA's CRL cited concerns regarding potential underexposure in lower weight pediatric patients and an issue with an analytical method used for production batch testing, requesting additional data and clarification.
  • Following this news, Pharming's American Depositary Receipt (ADR) price fell $3.495 per ADR, or 17.07%, closing at $16.975 per ADR on February 2, 2026.
Feb 6, 2026, 2:53 AM
Pharming Provides 2026 Financial Guidance and Pipeline Updates at Investor Day
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported preliminary 2025 revenue of approximately $376 million, marking a 27% increase over 2024, with Reconnect revenues at $318 million and Joenja at $58 million.
  • The company issued 2026 revenue guidance of $405 million to $425 million, projecting 8%-13% growth over 2025, driven by anticipated accelerating Joenja growth and continued Reconnect growth.
  • Key pipeline updates include leniolisib, with two phase 2 study readouts expected in H2 2026, and napazimod (KL1333), which is in a pivotal phase 2 (FALCON study) that passed a futility analysis and is projected to complete enrollment in 2026 for a readout in late 2027.
  • Pharming aims to become a leading global rare disease company, with napazimod positioned as a potential first standard of care for primary mitochondrial disease, targeting an addressable patient population of over 30,000 in key markets.
Feb 3, 2026, 3:00 PM
Pharming Provides 2026 Financial Guidance and Pipeline Updates
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported preliminary 2025 revenue of approximately $376 million, a 27% increase over 2024, driven by Reconnect revenue of $318 million (26% growth) and Joenja revenue of $58 million (29% growth).
  • For 2026, the company expects total revenues between $405 million and $425 million, representing 8%-13% full-year growth over 2025, with Joenja growth accelerating by approximately 10 percentage points higher than in 2025.
  • The company anticipates 2026 operating expenses between $300 million and $335 million, including over $60 million in incremental R&D investments, and projects a 90% gross margin.
  • Pharming has two leniolisib Phase 2 studies for PIDs with immune dysregulation on track for readouts in the second half of 2026, and enrollment for the napazimod pivotal Phase 2 study for primary mitochondrial disease is expected to complete in 2026 with a readout in late 2027.
Feb 3, 2026, 3:00 PM
Pharming Reports Strong 2025 Performance and Issues 2026 Financial Guidance
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming announced preliminary 2025 revenue of approximately $376 million, marking a 27% increase over 2024, with RUCONEST contributing $318 million and Joenja $58 million.
  • For 2026, the company projects total revenues between $405 million and $425 million, an 8%-13% growth over 2025, driven by mid-single-digit growth for RUCONEST and significant acceleration for Joenja.
  • The pipeline includes leniolisib, with two Phase II study readouts anticipated in H2 2026, and napazimone (KL1333) for primary mitochondrial disease, which passed futility analysis in its pivotal Phase II study and expects enrollment completion in 2026 with a readout in late 2027.
  • Pharming concluded 2025 with $181 million in cash and marketable securities and forecasts 2026 operating expenses between $300 million and $335 million, including over $60 million for incremental R&D investments.
Feb 3, 2026, 3:00 PM