NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Pharming Group N.V. (“Pharming” or the “Company”) (NASDAQ: PHAR). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Pharming and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On February ...

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].

Core Viewpoint - Pharming Group N.V. is under investigation for potential securities fraud following the FDA's Complete Response Letter regarding its drug Joenja® [1][2] Group 1: Company Overview - Pharming Group N.V. is a biopharmaceutical company focused on developing innovative therapies for rare diseases [2] - The company’s stock, represented by American Depositary Receipts (ADRs), experienced a significant decline of 17.07% following negative FDA news [2] Group 2: FDA Response - On February 1, 2026, the FDA issued a Complete Response Letter for Pharming's supplemental New Drug Application for Joenja® [2] - The FDA raised concerns about potential underexposure in lower weight pediatric patients and requested additional pharmacokinetic data [2] - An issue was also identified with one of the analytical methods used for production batch testing, necessitating further data and clarification [2] Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Pharming investors regarding possible securities fraud or unlawful business practices by the company and its officers [1] - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud [3]

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]

Core Viewpoint - The focus is on high-growth companies in sectors expected to experience exponential expansion, emphasizing the importance of innovation and disruptive technologies for substantial returns [1]. Group 1: Investment Strategy - The investment approach combines fundamental analysis with future trend predictions, aiming to identify and invest in forward-thinking enterprises [1]. Group 2: Market Perspective - There is a strong belief in the potential of innovation to drive significant financial returns, highlighting the importance of staying ahead in rapidly evolving industries [1].

Core Viewpoint - The focus is on high-growth companies in sectors expected to experience exponential expansion, emphasizing the importance of innovation and disruptive technologies for substantial returns [1]. Group 1: Investment Strategy - The investment approach combines fundamental analysis with predictions of future trends, aiming to identify and invest in forward-thinking enterprises [1]. Group 2: Market Perspective - There is a strong belief in the potential of innovation to drive significant financial returns, highlighting the importance of staying ahead in rapidly evolving industries [1].

Core Viewpoint - A top executive at German utility Uniper has downplayed European concerns regarding the increasing reliance on liquefied natural gas (LNG) imports from the United States, emphasizing that companies engage in contracts with firms to secure their energy needs [1] Group 1 - Uniper's executive suggests that the contracts signed with U.S. LNG suppliers are a strategic move to ensure energy security for Europe [1] - The executive indicates that the concerns about dependency on U.S. LNG are overstated and that companies are taking necessary steps to manage their energy portfolios [1] - The discussion highlights the broader context of Europe's energy transition and the role of LNG in diversifying energy sources [1]

Core Insights - Pharming is presenting its financial guidance for the year and highlighting its clinical stage pipeline programs during the 2026 Investor Day [1][2] - The company has evolved from a single asset company to a fast-growing biotech with two commercial assets experiencing double-digit growth and a late-stage pipeline with two programs each having over $1 billion sales potential [3] Financial Update - A short business and financial update will be provided, focusing on the financial guidance for the year [2] - The company emphasizes its growth trajectory and the potential of its pipeline programs [3] Pipeline Overview - The presentation will include two longer sessions dedicated to the pipeline, specifically on leniolisib for high prevalence primary immunodeficiencies (PIDs) and KL1333, napazimone [2]

Summary of Pharming Group 2026 Investor Day Company Overview - **Company**: Pharming Group (NasdaqGM:PHAR) - **Event**: 2026 Investor Day held on February 3, 2026 - **CEO**: Fabrice Chouraqui Financial Performance - **2025 Revenue**: Approximately $376 million, a 27% increase from 2024, slightly exceeding previous guidance [5][6] - **Reconnect Revenue**: $318 million, a growth of 26% year-over-year [7] - **Joenja Revenue**: $58 million, a growth of 29% [7] - **Gross Margin**: Expected around 88%-89% for 2025, excluding a $5 million milestone payment to Novartis [8] - **Cash Position**: $181 million in cash and marketable securities at the end of 2025 [9] 2026 Financial Guidance - **Expected Revenue**: Between $405-$425 million, implying growth of 8%-13% over 2025 [9] - **Reconnect Growth**: Mid-single-digit growth expected, with a decline in ex-U.S. revenues due to market exit [9] - **Joenja Growth**: Anticipated to accelerate, with annual growth around 10 percentage points higher than in 2025 [9] - **Operating Expenses**: Expected between $300 million-$335 million, including over $60 million in R&D investments [10][11] Pipeline and Product Development - **Leniolisib**: Focused on high-prevalence primary immunodeficiencies (PIDs) and is in pivotal phase 2 trials [4][31] - **KL1333 (napazimod)**: Targeting primary mitochondrial disease, also a billion-dollar opportunity [4] - **Joenja**: Committed to pediatric label expansion despite FDA response; Type A meeting scheduled for March [3][10] - **Market Potential**: Both Reconnect and Joenja have over $1 billion sales potential each [2] Market Dynamics - **Reconnect**: Positioned as a cornerstone treatment for difficult-to-treat patients, with a mechanism that provides reliability during crises [2][30] - **Joenja**: Growth opportunities identified in APDS, with potential to reclassify about 250 VUS patients as APDS over time [3] - **CVID Expansion**: Plans to expand into larger PIDs and CVID, unlocking a much larger market [4] Clinical Insights - **Leniolisib's Role**: Investigated for treating immune dysregulation in PIDs, with a strong scientific rationale and patient need [55][56] - **CVID and APDS**: Clinical overlap noted, with a significant portion of CVID patients exhibiting similar characteristics to APDS [44][46] - **Patient Experience**: Anecdotal evidence suggests that leniolisib has provided hope and improved quality of life for patients with CVID [53] Regulatory and Approval Status - **FDA Engagement**: Plans to engage with the FDA regarding pediatric approval for Joenja and address concerns raised in the recent CRL [15][29] - **EMA Approval**: Expected approval for leniolisib in the first half of 2026 [32] Conclusion - Pharming Group is positioned for substantial growth with a strong pipeline and financial performance. The company is focused on expanding its market presence in rare diseases, particularly through innovative treatments like leniolisib and Joenja, while maintaining financial discipline and strategic investments in R&D.

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]