MONTREAL, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for NIKTIMVO® (axatilimab) for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years ...

Metzger emphasized Revuforj’s role in helping eligible AML patients reach transplant earlier in treatment, noting physicians are increasingly using it in second- and third-line settings rather than later lines. He also highlighted the ability to restart patients on therapy post-transplant as maintenance, which he said has become an important growth driver.In discussing Revuforj (revumenib), Metzger attributed fourth-quarter growth—described by the moderator as 38%—to continued penetration in its initial lab ...

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals (NasdaqGS:SNDX) - **Date**: February 12, 2026 - **Key Speakers**: Michael Metzger (CEO), Nick Botwood (CMO, Head of R&D), Keith Goldan (CFO) Core Points and Arguments Financial Performance - **Revuforj**: Achieved $125 million in annual net sales, with a quarter-over-quarter growth of 38% in Q4 2025, indicating strong market performance and expansion in its labeled indications [2][4] - **Niktimvo**: Generated $152 million in sales within the first 11 months of launch for chronic GVHD, also showing significant quarter-over-quarter growth [2] Product Development and Market Strategy - **Revuforj**: - Focused on KMT2A and NPM1 indications, with new NCCN guidelines and approvals driving growth [4][5] - Anticipated to capture a dominant market share in NPM1, similar to its established position in KMT2A [9] - Current maintenance therapy uptake for KMT2A is 35%-40%, with expectations to grow to 70%-80% over time [10][13] - **Niktimvo**: - Currently approved for later-line chronic GVHD, with a potential market of approximately 6,500 patients in the U.S. for third-line treatment, and an estimated peak opportunity approaching $1 billion [23][24] - Collaboration with Incyte involves a 50/50 profit split, with expectations for long-term growth in revenue share [24][26] Research and Development - **IPF Phase II Trial**: - Expected to read out in the second half of 2026, with a well-designed study focusing on forced vital capacity as the primary endpoint [30][34] - Strong preclinical data supports the role of CSF1R inhibition in IPF, with significant improvements noted in related conditions [32][40] - **Future Opportunities**: - Plans to explore the role of revumenib in myeloproliferative neoplasms (MPN), with promising preclinical results [20][21][22] Path to Profitability - Syndax aims for profitability potentially by 2027, supported by strong revenue from both Revuforj and Niktimvo, while maintaining flat operating expenses at $400 million [46] Additional Important Insights - The company is fully funded and does not require additional cash, positioning it well for future growth [46] - The collaboration with Incyte extends to future trials, including potential IPF studies, with shared costs and responsibilities [45] This summary encapsulates the key points discussed during the conference call, highlighting the financial performance, product development strategies, research initiatives, and the company's path to profitability.

Core Insights - Incyte (INCY) reported mixed Q4 earnings results, with non-GAAP EPS falling short of expectations while revenue exceeded them [1] - The significant market-moving factor was the 2026 guidance provided by management [1] Financial Performance - Non-GAAP EPS did not meet market expectations [1] - Revenue for the quarter surpassed expectations [1] Future Outlook - Management provided guidance for 2026, which was a key focus for investors [1]

For the transition period from to For the fiscal year ended December 31, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-K (mark one) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission File Number: 001-12400 INCYTE CORPORATION (Exact name of registrant as specified in its charter) (State of other jurisdiction of in ...

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Core Insights - Incyte Corporation reported fourth-quarter 2025 adjusted earnings of $1.80 per share, missing the Zacks Consensus Estimate of $1.94 due to higher operating expenses [1][9] - Total revenues for the fourth quarter reached $1.51 billion, reflecting a 28% year-over-year growth, driven by strong performance of Jakafi and Opzelura, and exceeding the Zacks Consensus Estimate of $1.35 billion [2][9] Revenue Breakdown - Jakafi sales amounted to $828.2 million, a 7% increase from the previous year, driven by an 11% rise in paid demand, surpassing the Zacks Consensus Estimate of $800 million [3][9] - Opzelura cream generated $207.3 million in sales, up 28% year over year, exceeding the Zacks Consensus Estimate of $195.9 million due to increased patient demand [4][9] - Newly approved Zynyz generated $31.7 million in sales, significantly up from the previous year and beating the Zacks Consensus Estimate of $21.7 million [5] - Iclusig sales were $34.2 million, a 25% year-over-year increase, surpassing the Zacks Consensus Estimate of $30.7 million [5] - Pemazyre sales reached $23.4 million, reflecting a 1% year-over-year increase, also exceeding the Zacks Consensus Estimate of $22.9 million [5] - Minjuvi's revenues totaled $41.9 million, up 28% year over year, slightly beating the Zacks Consensus Estimate of $41.2 million [6] New Product Approvals - Incyte and Syndax Pharmaceuticals received FDA approval for axatilimab-csfr, branded as Niktimvo, for GVHD treatment, generating $56 million in sales in Q4 2025, a 22% sequential increase [7] Financial Performance - Adjusted R&D expenses were $575.2 million, up 37% year over year, primarily due to investments in late-stage development assets [13] - Adjusted SG&A expenses were $365.3 million, up 22% from the prior year, driven by costs associated with U.S. oncology product launches [13] - As of December 31, 2025, Incyte's cash, cash equivalents, and marketable securities totaled $3.6 billion, up from $2.9 billion as of September 30, 2025 [15] Full-Year Results and Guidance - For 2025, Incyte generated revenues of $5.14 billion, a 21% year-over-year growth, beating the Zacks Consensus Estimate of $4.97 billion [16] - The company expects Jakafi revenues in the range of $3.22-$3.27 billion for 2026, with Opzelura net product revenues projected between $750-$790 million [17]

分组1 - Incyte reported quarterly earnings of $1.8 per share, missing the Zacks Consensus Estimate of $1.94 per share, but showing an increase from $1.43 per share a year ago, resulting in an earnings surprise of -7.06% [1] - The company posted revenues of $1.51 billion for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 12.02%, compared to year-ago revenues of $1.18 billion [2] - Incyte has outperformed the S&P 500, with shares increasing about 10.4% since the beginning of the year, while the S&P 500 gained 1.7% [3] 分组2 - The current consensus EPS estimate for the coming quarter is $1.61 on revenues of $1.19 billion, and for the current fiscal year, it is $7.74 on revenues of $5.44 billion [7] - The Medical - Biomedical and Genetics industry, to which Incyte belongs, is currently in the top 36% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Financial Data and Key Metrics Changes - Total revenues for Q4 2025 reached $1.51 billion, a 28% increase year-over-year, while full-year revenues totaled $5.14 billion, up 21% year-over-year [5][30] - Net sales in Q4 were $1.22 billion, representing a 20% increase compared to the prior year, with full-year net sales at $4.35 billion, also up 20% year-over-year [6][30] - GAAP R&D expenses for Q4 were $611 million, a 31% increase from the prior year, with full-year R&D expenses at $2.05 billion [30] - GAAP SG&A expenses for Q4 were $390 million, increasing 19% year-over-year, with full-year SG&A expenses at $1.38 billion, up 11% year-over-year [30] Business Line Data and Key Metrics Changes - Core business sales excluding Jakafi totaled $1.26 billion, a 53% increase versus 2024, with significant contributions from Opzelura, Niktimvo, and Monjuvi [6][10] - Jakafi sales in Q4 were $828 million, a 7% increase year-over-year, with full-year sales at $3.093 billion, an 11% increase [7] - Opzelura's Q4 net sales were $207 million, up 28%, with full-year sales at $678 million, a 33% increase [9] - Hematology and oncology product sales in Q4 were $187 million, up 121% year-over-year, with full-year sales at $583 million, an 83% increase [10] Market Data and Key Metrics Changes - The U.S. market for Opzelura in atopic dermatitis (AD) is growing at nearly 20% year-over-year, while the vitiligo market is growing in the mid-teens [46] - The pediatric launch of Opzelura AD is annualizing around $30 million, indicating strong market uptake [9][46] - The international sales for Opzelura in vitiligo doubled to $130 million in 2025, with expectations for continued growth [9] Company Strategy and Development Direction - The company aims to transition its core business and pipeline, with multiple assets moving from early to late-stage development, targeting MPNs, pancreatic cancer, colorectal cancer, and hidradenitis suppurativa (HS) [4][5] - The company anticipates significant growth in its core business, potentially matching Jakafi's current size by 2030, driven by upcoming product launches [13] - The company is focused on expanding its hematology portfolio and advancing novel therapies in myeloproliferative neoplasms [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, highlighting a strong foundation for an inflection point in 2026 and beyond [5] - The company expects total revenues for 2026 to be between $4.77 billion and $4.94 billion, representing a 10%-13% increase from the prior year [32] - Management emphasized the importance of execution in orchestrating product launches and managing multiple phase three trials [35] Other Important Information - The company has submitted regulatory applications for Jakafi XR, Opzelura for moderate AD, and povorcitinib for HS in Europe [5] - The company plans to initiate 14 pivotal trials across seven assets by the end of 2026, reflecting a robust pipeline [14][17] Q&A Session Summary Question: Thoughts on CALR pivotal programs and dosing strategies - Management is discussing dosing strategies with the FDA to address differential potency across CALR mutations and is confident in their approach [39][40] Question: Opzelura uptake and average usage - The AD business is growing at nearly 20% year-over-year, with significant contributions from the pediatric launch and international markets [46][47] Question: Monjuvi's opportunity in front-line DLBCL - Monjuvi is positioned as an addition to R-CHOP, with a focus on a broad patient population, and management is optimistic about its competitive edge [54][55] Question: Opzelura in PN and FDA recommendations - The FDA recommended an additional trial for Opzelura in PN due to mixed results from previous studies, but there is no read-through to HS [62][66] Question: Updates on mCALR bispecific and V617F programs - The mCALR bispecific program is accelerating, and management is optimistic about the V617F program's potential to address a significant patient population [72][75]

Financial Data and Key Metrics Changes - In Q4 2025, total revenues reached $1.51 billion, a 28% increase year-over-year, while full-year revenues totaled $5.14 billion, up 21% from the previous year [5][31] - Net sales for Q4 were $1.22 billion, representing a 20% increase year-over-year, and full-year net sales were $4.35 billion, also up 20% year-over-year [6][31] - R&D expenses for Q4 were $611 million, a 31% increase from the prior year, with full-year R&D expenses at $2.05 billion [31] - SG&A expenses for Q4 were $390 million, increasing 19% year-over-year, with full-year SG&A expenses at $1.38 billion, up 11% year-over-year [31] Business Line Data and Key Metrics Changes - Core business sales excluding Jakafi totaled $1.26 billion in 2025, a 53% increase compared to 2024, with significant contributions from OPZELURA, Niktimvo, and MONJUVI [6][10] - Jakafi sales in Q4 were $828 million, a 7% increase year-over-year, with full-year sales at $3.093 billion, an 11% increase [7] - OPZELURA's Q4 net sales were $207 million, up 28%, with full-year sales at $678 million, a 33% increase [9] - Hematology and oncology product sales in Q4 were $187 million, up 121% year-over-year, with full-year sales at $583 million, an 83% increase [10] Market Data and Key Metrics Changes - The U.S. market for OPZELURA in atopic dermatitis and vitiligo is expanding, with pediatric launches contributing to a strong start, annualizing around $30 million [9][46] - The international sales for OPZELURA in vitiligo doubled to $130 million in 2025, with expectations for continued growth [9] - The hematology and oncology business is projected to generate $800 million-$880 million in 2026, representing a 40%-50% increase compared to 2025 [13] Company Strategy and Development Direction - The company aims to transition its core business and pipeline, with multiple assets moving from early to late-stage development, targeting MPNs, pancreatic cancer, colorectal cancer, and hidradenitis suppurativa [4][5] - The long-term goal is to nearly double the size of the core business excluding Jakafi by 2030, with significant growth expected from upcoming product launches [10][13] - The company is focused on expanding its pipeline with 14 pivotal trials across seven assets by the end of 2026, indicating a robust growth strategy [14][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, highlighting a strong foundation for an inflection point in 2026 and beyond [5][6] - The company anticipates continued revenue growth driven by strong commercial performance and an increase in milestone and contract revenue [5][6] - Management emphasized the importance of execution in orchestrating product launches and managing multiple Phase III trials [35] Other Important Information - Regulatory applications for Jakafi XR, OPZELURA, and povorcitinib were submitted on time, enhancing visibility into the company's growth profile [5][6] - The company is exploring business development opportunities to extend and strengthen its core, with a focus on strategic fit and potential for durable revenue [15] Q&A Session Summary Question: Thoughts on CALR pivotal programs and dosing strategies - Management is discussing dosing strategies with the FDA and is confident in their approach to address differential potency across mutations [39][40] Question: OPZELURA uptake and modeling sales - The AD business is growing at nearly 20% year-over-year, with significant contributions from pediatric launches and international markets [45][46] Question: MONJUVI's opportunity in front-line DLBCL - MONJUVI is positioned as an addition to R-CHOP, with a focus on addressing a broader patient population and competitive PFS benefits [52][54] Question: OPZELURA in prurigo nodularis and FDA recommendations - The FDA recommended an additional trial for OPZELURA in PN due to mixed results from previous studies, with no implications for HS [64][66] Question: mCALR bispecific and V617F program conviction - The mCALR bispecific program is accelerating, with a focus on differentiating it from current programs, while the V617F program is expected to generate promising data [73][75]