LONDON, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, October 28, 2025 at 8:30 a.m. Eastern Time to report its third quarter 2025 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upo ...

Core Viewpoint - Kiniksa Pharmaceuticals has received Orphan Drug Designation from the FDA for KPL-387, aimed at treating pericarditis, including recurrent cases, which highlights the company's commitment to addressing unmet medical needs in rare diseases [1][2]. Company Overview - Kiniksa Pharmaceuticals is focused on developing and commercializing novel therapies for diseases with unmet needs, particularly in cardiovascular indications [4]. - The company aims to improve the lives of patients suffering from debilitating diseases through innovative treatments [4]. Product Information - KPL-387 is a fully human IgG2 monoclonal antibody that targets human IL-1R1, inhibiting the activity of cytokines IL-1α and IL-1β [5]. - The drug is expected to offer a convenient treatment option for recurrent pericarditis patients, potentially allowing for a single monthly subcutaneous self-injection [2][5]. - Data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 trial is anticipated in the second half of 2026 [2]. Orphan Drug Designation - The FDA's Orphan Drug Designation is granted to products treating rare diseases, which includes those affecting fewer than 200,000 people in the U.S. [3]. - This designation provides financial incentives such as grant funding for clinical trials, tax advantages, and waivers for user fees [3].

If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Kiniksa Pharmaceuticals International, plc (KNSA) . This company, which is in the Zacks Medical - Biomedical and Genetics industry, shows potential for another earnings beat.This company has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average s ...

Shares of Kiniksa Pharmaceuticals International, plc (KNSA) have gained 1.3% over the past four weeks to close the last trading session at $37.03, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $47.88 indicates a potential upside of 29.3%.The average comprises eight short-term price targets ranging from a low of $35.00 to a high of $60.00, with a standard deviation of $7.94. Wh ...

Industry Overview - The biotech industry has shown resilience in 2025 despite ongoing geopolitical tensions and tariff threats, with significant investments in U.S. manufacturing by major pharma and biotech companies [1] - The Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology firms that develop innovative drugs using advanced technology [4] - The industry is currently ranked 102 by Zacks, placing it in the top 41% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical treatments [15] Mergers and Acquisitions - 2025 has experienced a surge in mergers and acquisitions, particularly focused on AI-driven drug discovery, as companies seek to expand their product portfolios [2][9] - Notable acquisitions include Roche's purchase of 89bio, Inc. for $3.5 billion and Novartis's acquisition of Tourmaline Bio for $1.4 billion, highlighting a trend towards portfolio expansion in response to changing market dynamics [10] Company Performance - Biotech companies such as Halozyme Therapeutics, Akero Therapeutics, Kiniska Pharmaceuticals, ANI Pharmaceuticals, and Twist BioScience are positioned to outperform the sector [3] - Halozyme Therapeutics has seen a 63.8% increase in shares year-to-date, with a Zacks Consensus Estimate for 2025 EPS rising to $6.18 [25] - Kiniska Pharmaceuticals has experienced an 82.4% share increase, with the Zacks Consensus Estimate for 2025 EPS rising to $1.03 [28] - ANI Pharmaceuticals shares have gained 73.6% this year, with earnings estimates for 2025 increasing by 84 cents [33] - Akero Therapeutics has seen a 66.8% increase in shares, focusing on treatments for metabolic diseases [36] - Twist Bioscience is expanding its technology to include synthetic RNA and antibody proteins, collaborating with Synthetic Design Lab for cancer treatments [41] Market Trends - The focus on innovation and execution is critical, with companies investing heavily in research and development to create breakthrough treatments [6] - The use of AI technology in drug discovery is expected to attract further investment in the biotech sector [11] - New drug approvals have accelerated in 2025, contributing to positive market momentum despite a challenging macro environment [11] Financial Metrics - The Zacks Biomedical and Genetics industry is trading at a trailing 12-month price-to-sales ratio of 2.16X, compared to the S&P 500's 5.95X and the Zacks Medical sector's 2.40X [20] - The industry's stock performance has gained 6% year-to-date, outperforming the Zacks Medical sector, which declined by 0.5% [17]

Core Viewpoint - The article emphasizes the importance of identifying and sustaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for maintaining momentum in stock prices [1]. Group 1: Investment Strategy - Investors can utilize the "Recent Price Strength" screen to identify stocks that are trending upwards, supported by strong fundamentals and trading near their 52-week high [2]. - Kiniksa Pharmaceuticals International, plc (KNSA) is highlighted as a strong candidate for trend investors, having increased by 26.1% over the past 12 weeks, indicating investor confidence in its potential [3]. - A recent price increase of 7% over the last four weeks suggests that KNSA's upward trend is still intact, and it is currently trading at 92.7% of its 52-week high-low range, indicating a potential breakout [4]. Group 2: Fundamental Analysis - KNSA holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for short-term price movements [5]. - The Zacks Rank system has a strong historical performance, with Rank 1 stocks averaging a +25% annual return since 1988, reinforcing the potential for KNSA's continued success [6]. - The Average Broker Recommendation for KNSA is also 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 3: Additional Opportunities - Besides KNSA, there are other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting a broader opportunity for investors to explore [7]. - The article encourages investors to consider various Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [7].

Company Highlights - Aurinia Pharmaceuticals Inc. (AUPH) has seen solid growth for its product LUPKYNIS, with expected net product sales for 2025 ranging from $250 million to $260 million, up from $216.2 million last year [2][3] - Arrowhead Pharmaceuticals Inc. (ARWR) is preparing for its first commercial launch in 2025, with its lead drug candidate Plozasiran under FDA review, decision expected on November 18, 2025 [4][5] - Beta Bionics Inc. (BBNX) reported a 54% growth in second-quarter net sales, with expectations for full-year 2025 net sales to range between $88 million and $93 million, compared to $65.1 million last year [7][8] - Kiniksa Pharmaceuticals International plc (KNSA) anticipates net product revenue for its drug Arcalyst to be between $625 million and $640 million for 2025, up from $417 million in 2024 [10][11] - Ionis Pharmaceuticals Inc. (IONS) generated net product sales of $19 million in Q2 2025, with a supplemental new drug application expected by year-end [12][14] - Stoke Therapeutics Inc. (STOK) is developing Zorevunersen for Dravet syndrome, with a 52-week high of $24.60 reached recently, representing an 82% gain in less than two months [16][17] - Fortress Biotech Inc. (FBIO) is awaiting an FDA decision on its investigational drug CUTX-101 for Menkes disease, expected on September 30, 2025 [18][21] Stock Performance - AUPH stock increased by 168% over 1.5 years, reaching a 52-week high of $12.87 [3] - ARWR stock gained 65% in less than 9 months, hitting a 52-week high of $31.13 [5] - BBNX stock rose nearly 55% in less than 4 months, reaching a 52-week high of $26.66 [8] - KNSA stock saw a 46% increase in less than four months, touching a 52-week high of $37.34 [11] - IONS stock gained 52% in less than two months, reaching a 52-week high of $64.72 [15] - STOK stock increased by 82% in less than two months, achieving a 52-week high of $24.60 [17] - FBIO stock rose by 61% in less than a month, reaching a 52-week high of $3.97 [21]

Financial Data and Key Metrics Changes - Kiniksa Pharmaceuticals reported Q2 revenue of $156.8 million, with a revised full-year revenue guidance for 2025 between $625 million and $640 million, up from a previous estimate of $590 million to $605 million [4][5][11] Business Line Data and Key Metrics Changes - The company has achieved approximately 15% penetration into its target patient population for Arclis, which is aimed at recurrent pericarditis, indicating significant growth potential [5][11][31] - The prescriber base for Arclis has expanded significantly, with over 3,475 prescribers by the end of Q2, marking a substantial increase in new patient enrollments [15][18] Market Data and Key Metrics Changes - The company noted that the recurrent pericarditis patient population is approximately 40,000 annually, with a significant opportunity remaining given the current 15% market penetration [31] - The introduction of the Inflation Reduction Act has made Arclis more affordable for Medicare Part D patients, leading to a one-time bolus of patients switching from free goods to paid therapy [20][21] Company Strategy and Development Direction - Kiniksa is focused on value creation and expanding its commercialization efforts for Arclis, with plans to enhance education among healthcare professionals regarding recurrent pericarditis [4][19] - The company is also developing KPL-387, a potential monthly liquid formulation for recurrent pericarditis, with expectations to enter the market around 2028-2029 [6][43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Arclis, emphasizing the need for continued education and awareness among physicians to improve diagnosis and treatment of recurrent pericarditis [17][30] - The company remains committed to being cash flow positive annually while pursuing new indication opportunities for its pipeline products [58] Other Important Information - Kiniksa is collaborating with Mayo Clinic and Johns Hopkins on a clinical trial for cardiac sarcoidosis, which may provide insights into myocardial inflammation and potential new treatment avenues [33][34] - The company is also advancing its development of KPL-161, a quarterly IL-1 antagonist, with ongoing preclinical studies [56] Q&A Session Summary Question: What are the drivers for the significant expansion in the prescriber base? - The expansion is attributed to increased education and understanding of recurrent pericarditis among healthcare professionals, as well as initiatives to establish centers of excellence for treatment [16][17] Question: How does the company view the impact of Medicare Part D on patient treatment? - The changes in Medicare Part D have made therapy more affordable, leading to a one-time increase in patients transitioning to paid therapy, although this is not expected to repeat [20][21] Question: What is the average treatment duration for Arclis and what drives the increase? - The average treatment duration is currently 30 months, with many patients restarting therapy within eight weeks if symptoms return [24][25] Question: What is the rationale for exploring Arclis in cardiac sarcoidosis? - The exploration is based on the inflammatory nature of cardiac sarcoidosis and the potential for IL-1 pathway blockade to reduce inflammation in this condition [32][33] Question: What are the expectations for KPL-387 and its market potential? - KPL-387 is anticipated to provide a more convenient monthly dosing option, with strong interest from both healthcare professionals and patients, potentially expanding the market for IL-1 therapies [38][39]

Financial Data and Key Metrics Changes - The company reported Q2 revenue of $156.8 million and raised its full-year 2025 revenue guidance to between $625 million and $640 million, up from a previous estimate of $590 million to $600 million [4][5][11]. Business Line Data and Key Metrics Changes - The company has achieved approximately 15% penetration into its target patient population for Arclis, which is focused on recurrent pericarditis, indicating significant room for growth [5][11][34]. - The average treatment duration for Arclis is reported to be 30 months, with 45% of patients who stop therapy restarting within eight weeks due to symptom recurrence [26][27]. Market Data and Key Metrics Changes - The prescriber base for Arclis has expanded significantly, with over 3,475 prescribers by the end of Q2, reflecting a strong educational push and increased awareness of recurrent pericarditis [15][19]. - The company noted that patients often receive multiple misdiagnoses before being correctly identified as having recurrent pericarditis, highlighting the need for better education and awareness in the healthcare system [18]. Company Strategy and Development Direction - The company is focused on value creation and expanding its market presence, particularly for Arclis, which has only begun to penetrate the market [4][5]. - The development pipeline includes KPL-387, a potential monthly liquid formulation for recurrent pericarditis, expected to enter the market around 2028-2029 [6][46]. - The company is also exploring the use of Arclis in cardiac sarcoidosis, aiming to understand myocardial inflammation better through collaborations with leading medical institutions [35][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Arclis, emphasizing the importance of education and awareness in increasing prescriber confidence and patient access [19][33]. - The company remains committed to being cash flow positive annually while pursuing new indication opportunities for its pipeline products [59]. Other Important Information - The company has implemented a patient assistance program to help Medicare Part D patients afford their co-pays, which has positively impacted patient enrollment and therapy initiation [22][23]. - The company is leveraging AI and digital approaches to enhance its educational outreach to healthcare professionals and patients [20][19]. Q&A Session Summary Question: What are the growth drivers for Arclis? - The growth is driven by increased education and understanding of recurrent pericarditis among healthcare providers, leading to a broader prescriber base and higher patient enrollments [18][19]. Question: How does Medicare Part D impact patient treatment? - The changes in Medicare Part D have made therapy more affordable for patients, resulting in a one-time bolus of patients transitioning from free goods to paid therapy [22][23]. Question: What is the average treatment duration for Arclis? - The average treatment duration is reported to be 30 months, with many patients restarting therapy quickly if symptoms return [26][27]. Question: What is the strategy for KPL-387? - KPL-387 is being developed as a monthly auto-injector formulation, with strong interest from both healthcare professionals and patients, indicating a potential expansion of the market for interleukin inhibitors [40][42]. Question: What are the benefits of the Fc modified IL-1 antagonist, eleven sixty one? - The Fc modification allows for longer circulation times and potentially quarterly dosing, which could be beneficial for chronic diseases requiring long-term management [56][57].

Group 1 - The Citi Biopharma and Back-to-school Conference is in its 20th annual iteration, having skipped last year and integrated biotech companies into the Global Healthcare Conference in Miami [1] - Kiniksa is participating in the conference, with key executives including CEO Sanj Patel, CCO Ross Moat, and Chief Medical Officer John Paolini present [2]