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Pharming Group N.V. (PHARM) is a biotech company focused on developing therapeutic protein products for the treatment of rare diseases. The company's flagship product, RUCONEST®, is marketed for the treatment of acute Hereditary Angioedema attacks. In addition, Joenja® (leniolisib) is the first approved disease modifying treatment for APDS in the U.S. Pharming Group N.V. is actively engaged in pediatric clinical development and expanding leniolisib's applications beyond APDS.
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Pharming Group N.V. announces its 2024 Annual General Meeting of Shareholders with key agenda items including director reappointments, remuneration policy adoption, share issuance authorization, and share repurchase authorization.
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Pharming Group N.V. releases its Annual Report for the year ending December 31, 2023, filing with both Euronext Amsterdam and Nasdaq. The report is available on Pharming's website and SEC filings.
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Pharming Group N.V. announces its participation in upcoming investor conferences in April 2024, including the 23rd Annual Needham Virtual Healthcare Conference and Van Lanschot Kempen Life Sciences Conference.
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Pharming Group N.V. reports a strong financial performance in 2023 with total revenues increasing by 19% to US$245.3 million. RUCONEST® revenues grew by 10% to US$227.1 million, and Joenja® (leniolisib) saw a successful launch with revenues of US$18.2 million. The company has a strong cash position of US$215.0 million and has provided a revenue guidance of US$280 million – US$295 million for 2024.
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Pharming Group N.V. announces the release of its preliminary financial results for Q4 and full year 2023 on March 14, 2024, with a presentation scheduled for analysts and investors. The company will host a conference call and live webcast for participants to engage with management and ask questions.
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Pharming Group N.V. announces participation in investor conferences in February, including Oppenheimer 34th Annual Healthcare Life Sciences Virtual Conference and UBS European Healthcare Conference. CEO Sijmen de Vries to present at the Oppenheimer conference on February 13. Webcast and replay available on Pharming's website.
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Pharming Group N.V. (PHARM) expects 10% growth in RUCONEST® revenue, significantly exceeding prior guidance. Joenja® revenues of approximately US$18 million with 81 patients on paid therapy at year end. Total revenues expected to increase by 19% to approximately US$245 million for full year 2023. The company aims to further develop its rare disease pipeline and footprint, seeking to significantly expand the leniolisib market opportunity.
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Pharming Group N.V. (PHARM/Nasdaq: PHAR) expands its rare disease pipeline with plans to develop leniolisib for additional primary immunodeficiencies (PIDs) beyond activated phosphoinositide 3-kinase delta syndrome (APDS). The Phase 2 clinical trial for leniolisib in PIDs with immune dysregulation linked to PI3Kẟ signaling is planned to start in 2Q 2024. The trial aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy in approximately 12 patients, with the potential to inform a subsequent Phase 3 program.
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Pharming Group N.V. (PHARM) announces the dosing of the first patient in the Phase III pediatric clinical trial evaluating a new pediatric granulated formulation of leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in children ages one to six years, with activated phosphoinositide 3-kinase delta syndrome (APDS). The multinational study aims to evaluate the safety, tolerability, and efficacy of leniolisib in 15 children with a confirmed APDS diagnosis, using a specific, pediatric granulated formulation of the drug. The primary and secondary endpoints of the trial align with previous leniolisib Phase II/III APDS trials for older patients. The company's Chief Medical Officer expressed commitment to providing new treatment options for younger pediatric patients with APDS, aiming to facilitate additional regulatory filings to expand the potential patient population benefiting from this treatment. This is the second pediatric clinical trial launched by Pharming this year for the study of leniolisib in pediatric patients with APDS, following the FDA approval of leniolisib for the treatment of APDS in adult and pediatric patients 12 years of age and older.
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Pharming Group N.V. (PHARM) Receives Day 180 Second List of Outstanding Issues from EMA for Leniolisib MAA, Expects CHMP Opinion in Q1 2024
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FAQ
What is Pharming Group N.V. focused on?
Pharming Group N.V. is a biotech company specializing in therapeutic protein products for rare diseases.
What are the key products of Pharming Group N.V.?
The company's main products include RUCONEST® for acute HAE attacks and Joenja® (leniolisib) for APDS.
Where is leniolisib approved for use?
Leniolisib is currently approved for use in the U.S. and is undergoing further regulatory, clinical, and commercial strategy updates.
What does Pharming Group N.V. anticipate for 2024?
In 2024, Pharming Group N.V. anticipates continued growth and development, including expanding leniolisib for additional indications and pediatric clinical development.
What are the additional markets Pharming Group N.V. is targeting?
Apart from the U.S., Pharming Group N.V. is expanding its market presence in Canada, Australia, Israel, and the European Economic Area.
How is Pharming Group N.V. involved in pediatric clinical development?
Pharming Group N.V. is actively engaged in developing leniolisib for pediatric clinical applications and exploring its efficacy beyond APDS.
What is the financial outlook for Pharming Group N.V.?
The company is focused on convertible bond refinancing and projects a positive financial outlook for the upcoming years.
How can I access further public information about Pharming Group N.V.?
For more public information about Pharming Group N.V., interested parties can reach out through the provided contact details.
What is the primary focus of Pharming Group N.V. in terms of rare diseases?
Pharming Group N.V. primarily focuses on developing therapeutic protein products for rare diseases, with a strong emphasis on HAE and APDS treatments.
What sets Pharming Group N.V. apart in the biotech industry?
Pharming Group N.V. distinguishes itself through its innovative product portfolio, including RUCONEST® and leniolisib, addressing critical unmet medical needs in the rare disease segment.
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