​ABIVAX Société Anonyme (NASDAQ:ABVX) is one of the Hot Growth Stocks to Invest in Now. On October 13, Etzer Darout from Barclays initiated ABIVAX Société Anonyme (NASDAQ:ABVX) with an Overweight rating and a $142 price target. ​Analysts noted that they initiated coverage on eight companies in the inflammation, immunology, oncology, and rare disease sectors. He elaborated that while investment in small and mid-cap biotechnology stocks has binary risks. However, investments based on the prior clinical data ...

Core Insights - The article highlights the author's academic background in Economics, Finance, and Data Science at Imperial College London, along with leadership experience as President of the Imperial College Investment Society, which is recognized as the top student business and finance society in the UK [1] - The author has practical experience in M&A deals at Edenity, a boutique advisory firm, where they developed valuation models and performed strategic transaction analyses [1] - Contributions to Seeking Alpha include merger arbitrage stock picks, providing insights on market opportunities driven by M&A activities [1] Summary by Categories Education and Leadership - The author is pursuing a BSc in Economics, Finance, and Data Science at Imperial College London [1] - Serves as President of the Imperial College Investment Society, the leading student business and finance society in the UK [1] Professional Experience - Gained hands-on experience working on live M&A deals at Edenity, focusing on valuation models and strategic transaction analyses [1] Contributions to Financial Analysis - Provides merger arbitrage stock picks on Seeking Alpha, offering M&A-driven insights into market opportunities [1]

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].

PresentationI would now like to hand the conference over to your speaker today, Pat Malloy. Please go ahead.Good day, and thank you for standing by. Welcome to the ABIVAX management call to discuss late-breaking ABTECT at UEG Conference. [Operator Instructions] Please be advised that today's conference is being recorded.Patrick MalloySenior Vice President of Investor Relations Great. Thank you, Sandra, and good morning and good afternoon to everybody, and thank you for joining today's call to discuss the re ...

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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]

Summary of ABIVAX Conference Call - October 06, 2025 Company Overview - **Company**: ABIVAX (NasdaqGM:ABVX) - **Event**: Conference call discussing late-breaking abstracts presented at the UEG conference in Berlin Key Points Industry and Product Focus - **Product**: Oripazimod, a first-in-class molecule for treating ulcerative colitis (UC) [5][6] - **Target Population**: Patients with severe refractory ulcerative colitis, including those who have failed multiple therapies, including JAK inhibitors [9][10] Clinical Data Highlights - **Phase III Trials**: Two induction trials leading to a maintenance trial, with a focus on the most refractory patient population [7][8] - **Patient Severity**: Approximately 60% of patients had the highest endoscopic severity score (3) [10] - **Treatment History**: About 50% of patients had previously failed at least one advanced therapy, with a notable number being JAK refractory [10][11] - **Efficacy Metrics**: - Delta of 16% in clinical response for the 50 mg dose compared to placebo, and 13% for the 25 mg dose [11] - Significant endoscopic improvement observed, particularly in patients with high baseline severity [14][15] Safety and Tolerability - **Adverse Events**: Headaches were the most common side effect, with no significant difference in serious treatment-emergent adverse events between the treatment and placebo groups [20][21] - **Lipase Levels**: Elevations in lipase were noted but were below typical thresholds for clinical concern, with no associated abdominal pain or pancreatitis [78][79] Future Expectations and Positioning - **Maintenance Data**: Anticipated to be released next year, with expectations that it may show improved outcomes over Phase II data [77][78] - **Positioning in Treatment Spectrum**: The drug is expected to be positioned as a first-line treatment for naive patients and as an option for those with multiple therapy failures [36][40] - **Market Awareness**: Increased recognition and enthusiasm for oripazimod among clinicians, with a focus on its oral administration and potential to improve patient quality of life [90][91] Additional Insights - **Dosing Flexibility**: Emphasis on the ability to adjust dosing based on patient response and severity, with a preference for higher doses in refractory cases [66][67] - **Long-term Efficacy**: Historical data suggests that patients may continue to improve over time, indicating the need for longer observation periods in refractory populations [46][48] Conclusion - **Overall Sentiment**: Positive outlook on oripazimod's potential to become a leading treatment option for ulcerative colitis, with ongoing data collection and analysis to support its efficacy and safety profile [98][99]

Efficacy of Obefazimod in Ulcerative Colitis - In pooled ABTECT 1 & 2 trials, Obefazimod 50mg demonstrated a statistically significant clinical remission rate, with a 16.4% difference compared to placebo (p<0.0001)[19] - Obefazimod 25mg also showed a statistically significant clinical remission rate, with a 13.2% difference compared to placebo (p<0.0001)[19] - The 50mg dose achieved clinically meaningful improvements in all clinical endpoints, regardless of prior advanced therapy inadequate response (AT-IR)[23] - In patients *with* prior AT-IR, Obefazimod 50mg showed a 31% improvement in clinical remission compared to placebo (p<0.0001)[24] - In patients *without* prior AT-IR, Obefazimod 50mg showed a 26% improvement in clinical remission compared to placebo (p<0.0001)[24] - The 50mg dose also achieved clinically meaningful improvements in endoscopic and histologic endpoints regardless of prior AT-IR[27] - Clinical response with the 50mg dose was consistent across subgroups, including those with no prior AT-IR through 4+ AT-IR or JAK-IR[31] Safety Profile of Obefazimod - In the pooled ABTECT 1 & 2 full dataset, the most common treatment-emergent adverse event (TEAE) was headache, with an incidence of 24.1% in the Obefazimod 50mg group[36] - The rate of TEAEs leading to study drug discontinuation was 5.0% in the Obefazimod 50mg group[35] - Serious TEAEs occurred in 3.1% of patients in the Obefazimod 50mg group[35]

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]

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]