Pharming Group N.V.
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Pharming Group to report fourth quarter and full year 2025 financial results and provide business update on March 12
Globenewswire· 2026-02-26 07:00
Core Viewpoint - Pharming Group N.V. will report its preliminary (unaudited) financial results for Q4 and full year 2025 on March 12, 2026, along with a business update [1]. Group 1: Financial Reporting - The company will provide preliminary financial results for the fourth quarter and full year 2025 [1]. - A conference call and webcast for analysts and investors will be held on the same day at 13:30 CET/08:30 am EDT [1]. Group 2: Participation Details - Registration is required to participate in the conference call or to watch the live webcast [2]. - Dial-in information and a unique PIN will be provided upon registration, and questions will only be taken from dial-in attendees [3]. Group 3: Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for patients with rare and life-threatening diseases [5]. - The company is headquartered in Leiden, the Netherlands, with a significant number of employees based in the U.S. [5].
Pharming Group to present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-17 07:00
Core Viewpoint - Pharming Group N.V. will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference, scheduled for February 25-26, 2026, highlighting its commitment to engaging with investors and stakeholders in the biopharmaceutical sector [1][2]. Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for patients with rare, debilitating, and life-threatening diseases [3]. - The company is headquartered in Leiden, the Netherlands, with a significant number of employees based in the U.S. [3]. Event Details - Fabrice Chouraqui, CEO, and Anurag Relan, M.D., CMO, will present on February 25 at 12:40 PM ET / 6:40 PM CET, with a live webcast available on Pharming's website [2]. - Investors can schedule one-on-one meetings with Pharming's management team through Investor Relations [2].
Pharming Group Investor Day: 2026 revenue outlook tops Street as Joenja growth, readouts loom
Yahoo Finance· 2026-02-04 09:18
Core Insights - Pharming Group forecasts 2026 revenue between $405 million and $425 million, representing an 8% to 13% growth compared to 2025, exceeding analyst expectations of approximately $398 million [1][10] - The company emphasizes continued revenue growth, disciplined spending, and multiple clinical readouts expected over the next two years [4] Financial Guidance - For 2026, Pharming expects operating expenses to be between $300 million and $335 million, with a gross margin of approximately 90% [1][12] - The company reported preliminary 2025 revenue of around $376 million, a 27% increase from 2024, with Joenja revenue surpassing $50 million [7][9] Commercial Portfolio - RUCONEST is projected to generate $318 million in 2025, reflecting a 26% year-over-year growth, while Joenja is expected to reach $58 million, up 29% [9] - CEO Fabrice Chouraqui highlighted RUCONEST's durability and its role as a reliable treatment for hereditary angioedema patients, noting its complex manufacturing process [5][14] Regulatory and Pipeline Updates - Pharming plans to request a Type A meeting with the FDA in March regarding pediatric dosing for Joenja, which has been excluded from 2026 revenue guidance due to regulatory uncertainties [2][6][11] - Management anticipates two phase II readouts for leniolisib (Joenja) in H2 2026 and an EMA decision in H1 2026, alongside a pivotal trial for napazimone (KL1333) with results expected in late 2027 [3][16][21] Market Dynamics - RUCONEST's growth is expected to be driven by U.S. volume growth, with a 3% price increase implemented in line with CPI [14] - The company has not included potential revenue from reclassification of VUS patients in its guidance due to timing uncertainties [15]
Pharming Group announces 2026 financial guidance and highlights rare disease pipeline at Investor Day
Globenewswire· 2026-02-03 06:00
Core Insights - Pharming Group N.V. has announced its financial guidance for 2026, projecting total revenues between US$405 million and US$425 million, representing an 8% to 13% growth [3][7][8] - The company will highlight its advancing clinical-stage pipeline, focusing on two major programs targeting primary immunodeficiencies and mitochondrial diseases during its Investor Day [2][4][6] Financial Guidance - Total revenue guidance for 2026 is set between US$405 million and US$425 million, driven by growth in its commercial products [3][8] - Total operating expenses are expected to be between US$330 million and US$335 million, primarily due to increased R&D expenses related to ongoing clinical trials [7][8] Pipeline Overview - Leniolisib is being developed for primary immunodeficiencies with immune dysregulation, with ongoing Phase II trials expected to yield top-line data in the second half of 2026 [4][5] - Napazimone (KL1333) is being developed for mtDNA-driven mitochondrial disease, with a pivotal clinical trial ongoing and results anticipated in 2027 [6][9] Clinical Programs - Leniolisib is currently approved as Joenja in the U.S. and is the first targeted treatment for activated PI3Kδ syndrome, with potential applicability across broader patient populations [5][6] - Napazimone (KL1333) aims to become the first standard of care for mtDNA-driven mitochondrial disease, addressing significant unmet medical needs [6][9] Investor Day Details - The Investor Day will feature presentations from clinical experts discussing disease biology and the potential impact of Pharming's programs [10][16] - The event is scheduled for February 3, 2026, from 10:00 a.m. to 12:00 p.m. EST, and will be available via webcast [11]
Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja® (leniolisib) in children aged 4 to 11 years with APDS
Globenewswire· 2026-02-01 20:17
Core Viewpoint - Pharming Group announced that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for Joenja® (leniolisib) as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS) [1][5] Regulatory Update - The FDA raised concerns about potential underexposure in lower weight pediatric patients and requested additional pharmacokinetic data to reassess proposed doses [2] - An issue was identified with one of the analytical methods used for production batch testing, prompting the FDA to request further data and clarification [2] - Pharming plans to address the issues outlined in the CRL and intends to request a Type A meeting with the FDA to discuss next steps for resubmission [3] Clinical Data - The sNDA submission was based on positive results from a Phase III study showing improvements in lymphadenopathy and naïve B cells over 12 weeks, indicating a correction of the immune defect in children [4] - Safety data from 8 months of treatment indicated that all treatment-emergent adverse events were mild to moderate, with no serious drug-related adverse events reported [4] Market Context - Currently, there are no approved treatments for children with APDS under the age of 12 globally, highlighting the significance of Joenja's potential impact [5] - Joenja received FDA approval for treating APDS in patients aged 12 years and older in March 2023, which remains unaffected by the recent regulatory action [3][5] Disease Overview - APDS is a rare primary immunodeficiency characterized by severe recurrent infections and immune dysregulation, affecting approximately 1 to 2 people per million worldwide [6] - The condition is caused by variants in the PIK3CD or PIK3R1 genes, leading to hyperactivity of the PI3Kδ pathway, which impairs immune cell function [6] Product Information - Leniolisib is an oral PI3Kδ inhibitor approved in several countries as the first targeted treatment for APDS in patients aged 12 years and older [7] - The drug is currently under regulatory review in multiple regions and is being evaluated in clinical trials for other primary immunodeficiencies [8]
开了8年药店,被一张进货单“打醒”:原来这才是行业里不说破的暴利秘密
Sou Hu Cai Jing· 2026-01-11 06:12
Core Viewpoint - The article highlights the challenges faced by small and medium-sized pharmacies in the current market, emphasizing the importance of digital tools for procurement and inventory management to enhance profitability and efficiency. Group 1: Challenges in the Pharmacy Industry - Many small pharmacy owners are struggling with rising costs such as rent and labor, leading to compressed profit margins [1] - The industry is experiencing a phenomenon known as "killing the familiar," where long-term relationships with suppliers may lead to overpaying due to a lack of price comparison [3] - On average, small pharmacies incur hidden losses of 50,000 to 80,000 yuan annually due to improper procurement practices [3] Group 2: Digital Tools and Their Benefits - Successful pharmacies are utilizing digital tools like the "Drug Procurement Browser," which aggregates data from multiple B2B platforms to find the best prices [5][6] - This tool allows pharmacy owners to have a "God's perspective," enabling them to negotiate better prices and make informed purchasing decisions [7] - Implementing data-driven decision-making can significantly improve inventory turnover rates, with reported increases of over 30% [9] Group 3: Future of the Pharmacy Industry - The industry is anticipating a major shift by 2026, with stricter regulations and market consolidation, making digitalization essential for survival [10] - Efficiency will become a key competitive factor, and traditional methods like phone calls and Excel spreadsheets will not suffice [10] - Pharmacy owners are encouraged to adopt digital tools as price comparison aids to avoid overpaying due to information asymmetry [11][12]
Pharming Group reports preliminary 2025 revenues and announces Investor Day
Globenewswire· 2026-01-08 06:00
Core Viewpoint - Pharming Group N.V. reported preliminary, unaudited revenues for 2025, estimating approximately US$376 million, which exceeds previous guidance and indicates a 27% growth compared to 2024 [2][5] Financial Performance - Total revenues for 2025 are estimated at US$376 million, surpassing the revised guidance of US$365 to US$375 million [2] - This revenue growth is attributed to the continued success of RUCONEST® and increased demand for Joenja®, particularly in the U.S. market [2] - Full-year operating expenses are expected to be between US$304 million and US$308 million, reflecting the company's commitment to cost discipline [2] Future Outlook - The company anticipates sustained revenue growth and further advancements in its clinical pipeline for 2026 [2] - A complete financial report for Q4 and full year 2025 is scheduled for release on March 12, 2026 [2] Investor Day - Pharming will host a virtual Investor Day on February 3, 2026, to provide updates on its clinical pipeline and financial guidance for 2026 [1][3] - The agenda will include discussions on leniolisib and KL1333, focusing on their clinical trials and the unmet needs in related diseases [3][4] - Presentations will feature leading clinical experts discussing immune dysregulation and mitochondrial diseases, providing context for Pharming's development programs [4]
Best Momentum Stocks to Buy for Dec. 22
ZACKS· 2025-12-22 16:16
Here are three stocks with buy rank and strong momentum characteristics for investors to consider today, Dec. 22: Impala Platinum Holdings Limited (IMPUY) : This precious metals mining company has a Zacks Rank #1 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 6.4% over the last 60 days. Impala Platinum Holdings’ shares gained 24.7% over the last three months compared with the S&P 500’s decline of 3.3%. The company possesses a Momentum Score of A.Pharming Group N.V. (PHAR ...
Argenx, ServiceNow And Other Big Stocks Moving Lower In Monday's Pre-Market Session - argenx (NASDAQ:ARGX), Celldex Therapeutics (NASDAQ:CLDX)
Benzinga· 2025-12-15 13:06
Group 1 - U.S. stock futures are higher, with Dow futures gaining around 200 points [1] - Argenx SE shares fell 6% to $825.00 in pre-market trading after discontinuing Phase 3 studies of efgartigimod SC in thyroid eye disease [1] Group 2 - TryHard Holdings Ltd shares tumbled 15.2% to $13.16 in pre-market trading after a previous jump of 58% [2] - Site Centers Corp declined 13.4% to $6.33 in pre-market trading [2] - Exicure Inc dipped 8.7% to $5.80 in pre-market trading after gaining 5% on Friday [2] - Celldex Therapeutics Inc declined 8.4% to $25.19 in pre-market trading [2] - CapsoVision Inc fell 6.4% to $12.03 in pre-market trading after a decline of around 11% on Friday [2] - Zillow Group Inc fell 5.6% to $70.50 in pre-market trading [2] - BeOne Medicines AG declined 4.9% to $303.50 in pre-market trading [2] - ServiceNow Inc fell 4.7% to $824.50 in pre-market trading after a downgrade to Underweight by KeyBanc [2] - WaterBridge Infrastructure LLC fell 4.4% to $20.05 in pre-market trading [2] - Pharming Group N V declined 4.2% to $17.23 in pre-market trading [2]
Argenx, ServiceNow And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Benzinga· 2025-12-15 13:06
Group 1 - U.S. stock futures are higher, with Dow futures gaining around 200 points [1] - Argenx SE shares fell 6% to $825.00 in pre-market trading after discontinuing Phase 3 studies of efgartigimod SC in thyroid eye disease [1] Group 2 - TryHard Holdings Ltd shares tumbled 15.2% to $13.16 in pre-market trading after a previous jump of 58% [2] - Site Centers Corp declined 13.4% to $6.33 in pre-market trading [2] - Exicure Inc dipped 8.7% to $5.80 in pre-market trading after gaining 5% on Friday [2] - Celldex Therapeutics Inc declined 8.4% to $25.19 in pre-market trading [2] - CapsoVision Inc fell 6.4% to $12.03 in pre-market trading after a decline of around 11% on Friday [2] - Zillow Group Inc fell 5.6% to $70.50 in pre-market trading [2] - BeOne Medicines AG declined 4.9% to $303.50 in pre-market trading [2] - ServiceNow Inc fell 4.7% to $824.50 in pre-market trading after a downgrade to Underweight by KeyBanc [2] - WaterBridge Infrastructure LLC fell 4.4% to $20.05 in pre-market trading [2] - Pharming Group N V declined 4.2% to $17.23 in pre-market trading [2]