obefazimod

Search documents
 Abivax (NASDAQ:ABVX) Sees Positive Analyst Ratings Amid Promising Drug Results
 Financial Modeling Prep· 2025-10-07 02:00
 Core Viewpoint - Abivax (NASDAQ:ABVX) is experiencing positive momentum due to promising results from its experimental drug obefazimod for ulcerative colitis, leading to a reaffirmed "Buy" rating and an increased price target from BTIG [1][5].   Company Summary - Abivax is a biotech company focused on innovative treatments for inflammatory diseases, with a current stock price of $86.67, reflecting a 3.28% increase [1][4]. - The company's market capitalization is approximately $6.55 billion, indicating strong investor interest [4].   Drug Development Summary - Obefazimod has shown significant efficacy in treating ulcerative colitis, with patients achieving remission after just eight weeks of treatment, including those who were previously unresponsive to other therapies [2][5]. - The results of obefazimod have been described as "compelling," highlighting its potential as a novel oral treatment for inflammatory bowel disease [3].   Market Activity Summary - The stock has traded between $86.57 and $90.70 on the day, with a 52-week high of $92.91 and a low of $4.77, reflecting active trading and investor engagement [4]. - The success of obefazimod has increased its strategic appeal, particularly in the context of rising mergers and acquisitions within the pharmaceutical sector, suggesting strong interest from larger companies [3][5].
 Why Is Abivax Stock Trading Higher On Monday?
 Benzinga· 2025-10-06 15:05
 Core Insights - Abivax SA presented additional clinical data for obefazimod at the United European Gastroenterology Meeting, focusing on its efficacy for moderate-to-severely active ulcerative colitis [1][5] - The Phase 3 ABTECT trials demonstrated significant clinical response rates and safety profiles for obefazimod, indicating potential for market approval [2][4]   Group 1: Efficacy Data - In the pooled ABTECT 1 & 2 trials, obefazimod 50mg achieved a placebo-adjusted clinical response improvement of 28% in patients without prior advanced therapy inadequate response (AT-IR) and 29% in those with up to four prior AT-IR [2] - The treatment also showed a 34% placebo-adjusted clinical response in participants who previously failed JAK inhibitor therapy, along with significant improvements in endoscopic and histologic endpoints [3] - The 50mg once-daily dose met the FDA primary endpoint of clinical remission at Week 8, with ABTECT-1 showing a 19.3% and ABTECT-2 showing a 13.4% placebo-adjusted clinical remission rate [5][6]   Group 2: Safety Profile - Obefazimod was well-tolerated, with no new safety signals identified, and no serious, severe, or opportunistic infections or malignancies reported [4][5] - Both 25mg and 50mg doses demonstrated similar efficacy across clinical, endoscopic, and histological endpoints in participants without prior AT-IR [4]   Group 3: Market Reaction - Following the positive data release, Abivax's stock price increased by 5.71%, reaching $88.72 [6]
 Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies
 Globenewswire· 2025-10-06 08:00
 Core Insights - Abivax announced additional clinical data for obefazimod at the UEG Meeting, highlighting its efficacy in treating moderate-to-severely active ulcerative colitis [2][3] - The Phase 3 ABTECT trials demonstrated that obefazimod achieved clinically meaningful improvements across various patient subgroups, including those with prior inadequate responses to advanced therapies [4][7]   Study Population - A total of 1272 patients were enrolled in the ABTECT trials, with approximately 60% having an endoscopic subscore of 3 [3] - About 47% of the total population had a prior inadequate response to advanced therapy, with 21% having failed to respond to a JAK inhibitor [3]   Efficacy Results - The 50 mg dose of obefazimod showed clinically meaningful improvements in clinical remission, with a placebo-adjusted difference of 10% for patients with prior inadequate response (p=0.0009) and 22% for those without (p<0.0001) [4][7] - In participants without prior inadequate response, the 50 mg dose achieved a placebo-adjusted difference in clinical response of 28% (p<0.0001), while those with four or more prior inadequate responses showed a 29% difference (p=0.0242) [4][7] - The treatment also demonstrated a 34% improvement in clinical response for participants who previously failed JAK inhibitor therapy (p=0.0017) [4][7]   Safety Profile - Obefazimod was well tolerated, with no new safety signals identified for both the 25 mg and 50 mg doses [4][7]   Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [9]
 Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data
 Globenewswire· 2025-10-05 15:00
 Core Insights - Abivax announced results from the Phase 3 ABTECT 8-Week Induction Trials for obefazimod, aimed at treating moderate-to-severely active ulcerative colitis, during the UEG Meeting in Berlin [2][3] - The trials demonstrated significant clinical remission rates and safety data, highlighting the need for new therapies in this area [3][5]   Group 1: Trial Results - A total of 1,272 patients were enrolled in the ABTECT 1 & 2 trials, with a pooled clinical remission rate of 16.4% (p<0.0001) at the 50 mg once-daily dose at Week 8 [3][5] - ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001), while ABTECT-2 demonstrated a rate of 13.4% (p=0.0001) at the same dosage [3][5] - All key secondary efficacy endpoints were met in both trials, indicating robust performance of obefazimod [5]   Group 2: Safety Profile - No signals for serious, severe, or opportunistic infections or malignancies were observed in the trials [3][5] - The most commonly reported treatment-emergent adverse events (TEAEs) included headache (16% at 25 mg, 24.1% at 50 mg) and nausea (5% at 25 mg, 7.2% at 50 mg), with low discontinuation rates due to headaches [3][5]   Group 3: Future Developments - Abivax plans to present a second late-breaking abstract on October 6, 2025, and will host a conference call to discuss the topline results [4][5] - The company is focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [2][6]
 12 Best Performing Healthcare Stocks to Buy Right Now
 Insider Monkey· 2025-09-29 00:18
 Industry Overview - Healthcare spending in the US is projected to reach $5.3 trillion in 2023, making it one of the largest sectors globally [1] - The healthcare industry has shown mediocre returns over the past three years, with a decline of 3.6% in 2022, followed by slight increases of 0.3% in 2023 and 0.9% in 2024 [2] - The healthcare sector is one of four S&P 500 sectors experiencing negative returns in 2025 [2]   Regulatory and Political Environment - The underperformance of the healthcare sector in 2025 is attributed to the Trump administration's actions, including pressure for reduced drug pricing and tariffs on pharmaceuticals [3] - Cuts to programs like Medicaid and health research have exacerbated the challenges faced by healthcare organizations [3] - Ongoing political and regulatory uncertainties deter investment interest in the sector [4]   Long-term Outlook - Despite recent poor performance, the long-term outlook for the healthcare industry remains favorable due to the essential nature of its goods and services [4] - Many equities in the sector are currently trading at significant discounts, indicating potential investment opportunities [4][5]   Investment Strategy - The article emphasizes the importance of hedge fund interest in stocks, suggesting that mimicking top hedge fund picks can lead to market outperformance [8] - A methodology was employed to identify the best-performing healthcare stocks, focusing on those with year-to-date returns of 20% or more and ranked by hedge fund holdings [7]   Company Highlights - **Celcuity Inc. (NASDAQ:CELC)**: A clinical-stage biotechnology company focused on oncology therapies, with a lead drug candidate, gedatolisib, recently accepted for NDA by the FDA [10][11] - **ABIVAX Société Anonyme (NASDAQ:ABVX)**: Developing therapies for chronic inflammatory diseases, with positive Phase 3 trial results for its lead candidate, obefazimod, and plans for regulatory submissions in 2026 [13][15][16] - **Indivior PLC (NASDAQ:INDV)**: A pharmaceutical company specializing in opioid use disorder treatments, reporting strong Q2 results with a revenue increase and raised full-year guidance [17][18][19]
 Abivax Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting
 Globenewswire· 2025-09-23 20:05
 Core Insights - Abivax announced the presentation of a late-breaking abstract for its lead drug candidate, obefazimod, at the United European Gastroenterology Congress, highlighting its potential as a new treatment for moderately to severely active ulcerative colitis [2][3]   Company Overview - Abivax is a clinical-stage biotechnology company focused on developing innovative therapies for chronic inflammatory diseases, with obefazimod (ABX464) currently in Phase 3 clinical trials for ulcerative colitis [10]   Upcoming Events - The late-breaking abstract titled "EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES" will be presented on October 6, 2025, at 10 AM CET [7] - Abivax management will hold an analyst and investor call on October 6 at 3 PM CET to discuss the data [8] - A symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" will take place on October 6 from 5:30 PM to 6:30 PM CET [8]
 看好小分子偶联药物及相关标的
 CAITONG SECURITIES· 2025-07-28 08:00
 Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17]   Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29]   Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]
 深夜,暴涨近600%!中国资产也爆发
 天天基金网· 2025-07-24 03:30
 Core Viewpoint - The article highlights the strong performance of Chinese concept stocks and the overall positive sentiment in the market, driven by various factors including economic stability and policy support [2][8].   Group 1: Chinese Concept Stocks Performance - The Nasdaq Golden Dragon China Index rose nearly 1.4%, with notable gains in stocks such as Manulife and Brain Rejuvenation, which surged over 100% and 30% respectively [2]. - Major Chinese tech stocks showed significant increases, with Pinduoduo up over 4%, Tencent Holdings ADR up over 3%, and Meituan ADR up over 2% [6][7]. - The Shanghai Composite Index broke the 3600-point mark, while the Hang Seng Index and Hang Seng Tech Index approached four-year highs, indicating strong market momentum [7].   Group 2: International Investment Sentiment - Several foreign institutions have raised their forecasts for China's economic growth in 2025, citing stable economic performance and improving corporate earnings outlook [8]. - A report from Citi highlighted that despite macroeconomic fluctuations, Asian markets, particularly China and South Korea, are expected to outperform global peers, leading to upgraded ratings for these markets [8]. - Approximately 60% of Middle Eastern sovereign wealth funds plan to increase their allocation to Chinese assets over the next five years, reflecting a growing interest in China's digital technology, renewable energy, and advanced manufacturing sectors [8].   Group 3: Abivax Stock Surge - French biotechnology company Abivax saw its stock surge by nearly 600% after reporting strong results from its oral drug for ulcerative colitis in late-stage trials, demonstrating significant clinical efficacy and safety [11][13]. - Abivax plans to submit a new drug application to the FDA next year, contingent on further positive data [13].   Group 4: Meme Stocks Rally - The article discusses a resurgence of "meme stocks" in the U.S. market, with companies like Krispy Kreme and GoPro experiencing significant price increases, driven by retail investor enthusiasm [15][17]. - Krispy Kreme's stock rose nearly 40%, while GoPro surged over 70%, as these stocks were heavily shorted and gained traction on social media platforms [15][17]. - Analysts noted that the current rally in speculative stocks could indicate a potential market bubble, as these stocks outperformed those with consistent earnings [17].
 创新药概念反复活跃 键凯科技涨超10%
 news flash· 2025-07-24 01:49
 Group 1 - The core viewpoint of the article highlights the active performance of the innovative drug sector, with companies like JianKai Technology seeing a rise of over 10% [1] - Abivax, a French gastrointestinal drug developer, experienced a significant surge of 586% in its stock price after announcing positive results from its Phase III trials for its core drug obefazimod targeting moderate to severe active ulcerative colitis [1] - Other companies in the sector, including Nanjing Xinbai, Lianhuan Pharmaceutical, Weichip Bio, Dize Pharmaceutical, Shutaishen, and Kailaiying, also showed upward movement in their stock prices [1]
 深夜,暴涨近600%!中国资产也爆发
 Zheng Quan Shi Bao· 2025-07-23 15:20
 Group 1: Market Overview - The US stock market opened higher on July 23, with the Dow Jones Industrial Average up 0.5%, the Nasdaq slightly up by 0.07%, and the S&P 500 increasing by 0.27% [1][2] - The Nasdaq China Golden Dragon Index rose nearly 1.4%, indicating strong performance in Chinese concept stocks [2][4]   Group 2: Individual Stock Performance - Abivax, a French biotechnology company, saw its stock surge nearly 600% after reporting strong results for its oral ulcerative colitis treatment in late-stage trials [2][11] - Popular Chinese concept stocks included Pinduoduo, which rose over 4%, Tencent Holdings ADR up over 3%, and Meituan ADR increasing by over 2% [6][7]   Group 3: Meme Stocks Activity - Meme stocks experienced significant movements, with Krispy Kreme and GoPro joining the trend, with GoPro rising over 70% and Krispy Kreme nearly 40% [12][13] - The surge in these stocks is attributed to high short-selling ratios, with 28% of Krispy Kreme's float sold short and about 10% for GoPro [16]   Group 4: Economic Outlook - Several foreign institutions have raised their forecasts for China's economic growth in 2025, citing stable economic performance and improving corporate earnings [8] - A significant portion of sovereign wealth funds from the Middle East, Asia-Pacific, and Africa plan to increase their allocations to Chinese assets, reflecting renewed interest in the Chinese market [8]









