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2 Under-the-Radar Stocks That Have Soared This Year
The Motley Fool· 2025-12-09 21:45
These companies are worth your attention.Looking for stocks with explosive growth potential? Look no further than TransMedics Group (TMDX 1.32%) and Abivax Société Anonyme (ABVX +6.94%). Both healthcare specialists have seen their shares jump significantly this year already.However, there could be plenty more upside on the way for these little-known stocks. Here's why TransMedics Group and Abivax might be worth considering, especially for investors with an elevated risk tolerance.1. TransMedics GroupTransMe ...
SKYRIZI® (risankizumab) Receives Positive Reimbursement Recommendation by Canada’s Drug Agency for Ulcerative Colitis and AbbVie Concludes Letter of Intent with the pan-Canadian Pharmaceutical Alliance
Globenewswire· 2025-11-28 12:01
Core Insights - AbbVie has announced two positive updates for Canadians living with ulcerative colitis (UC) [1] - Canada's Drug Agency (CDA-AMC) has recommended SKYRIZI (risankizumab) for reimbursement under specific conditions for adults with moderately to severely active UC [2][3] - AbbVie has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI for UC, resulting in a signed Letter of Intent (LOI) [3][5] Summary by Sections Treatment Recommendations - The CDA-AMC's recommendation for SKYRIZI is based on feedback from 25 Canadian clinicians and two patient organizations, ensuring patient perspectives were included [3] - SKYRIZI is indicated for adults with UC who have had inadequate responses to conventional therapies, biologic treatments, or Janus kinase (JAK) inhibitors [8] Clinical Evidence - The positive recommendations for SKYRIZI were supported by evidence from pivotal phase 3 clinical trials, including MOTIVATE, ADVANCE, FORTIFY (for Crohn's disease), and INSPIRE, COMMAND (for UC) [5] Patient Impact - The introduction of SKYRIZI is seen as a significant step towards providing effective treatment options for UC patients, which can help improve their quality of life and long-term health outcomes [5][6] - Approximately 120,000 Canadians are estimated to live with UC, highlighting the need for effective treatment options [7] Company Commitment - AbbVie expresses commitment to improving patient access to innovative medicines for inflammatory bowel disease through collaboration with health authorities [6]
Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis
Globenewswire· 2025-11-03 21:05
Core Insights - Abivax announced significant improvements in patient-reported outcomes (PRO) from its Phase 3 ABTECT trials for obefazimod, indicating its potential to enhance the quality of life for patients with moderate-to-severely active ulcerative colitis [2][5] Summary by Categories Clinical Trial Results - The Phase 3 ABTECT trials demonstrated that 37% of patients on 50mg obefazimod reported no bowel urgency at week 8, compared to 18.1% in the placebo group (p<0.0001) [6] - 47.6% of patients on 50mg obefazimod reported no nocturnal bowel movements at week 8, compared to 24.7% in the placebo group (p<0.0001) [6] - Fatigue remission was reported by 17.1% of patients on 50mg obefazimod at week 8, compared to 7.7% in the placebo group (p=0.0001) [6] Patient-Reported Outcomes - PRO instruments evaluated included bowel urgency, nocturnal bowel movements, fatigue, overall quality of life, and workplace productivity [7] - Consistent improvements across all PRO instruments were observed, underscoring the meaningful benefits of obefazimod for patients' daily experiences [3][5] Future Developments - Abivax plans to present detailed PRO data at an upcoming medical conference and anticipates sharing results from a 44-week maintenance trial in the second quarter of 2026 [4][5] - The company is focused on developing effective and tolerable long-term therapies for ulcerative colitis [5][8]
ABIVAX (ABVX) Earnings Call Presentation
2025-07-22 20:30
ABTECT Phase 3 Program Overview - The ABTECT Phase 3 program included 2 induction trials (ABX464-105, ABX464-106) and 1 maintenance trial (ABX464-107) [25] - The trials enrolled 1,275 patients across 36 countries [20, 60] - The trials included both advanced therapy naïve (52.7%) and refractory patients (47.3%) [60] Efficacy Results - In ABTECT 1 (Study 105), the 50mg dose of obefazimod achieved a clinical remission rate of 21.7%, a 19.3% difference compared to placebo (2.5%) (p<0.0001) [33, 60] - In ABTECT 2 (Study 106), the 50mg dose of obefazimod achieved a clinical remission rate of 19.8%, a 13.4% difference compared to placebo (6.3%) (p=0.0001) [40, 60] - Pooled analysis of ABTECT 1 & 2 showed a clinical remission rate of 20.8% with 50mg obefazimod, a 16.4% difference compared to placebo (4.4%) (p<0.0001) [47, 60] - In ABTECT 1, the 25mg dose of obefazimod achieved statistically significant results on all key secondary endpoints [36] - In ABTECT 2, the 50mg dose of obefazimod achieved statistical significance on all key secondary endpoints [43] Safety and Tolerability - Obefazimod was generally well tolerated with no new safety signals observed in Phase 3 induction trials [20, 60] - In ABTECT 1, Any TEAE was 46.9% for Obe 25 mg, 59.4% for Obe 50 mg, and 53.2% for Placebo [52] - In ABTECT 2, Any TEAE was 50.9% for Obe 25 mg, 61.0% for Obe 50 mg, and 48.4% for Placebo [52] Next Steps - 44-week maintenance data is expected in Q2 2026 [25, 60]