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Abivax SA shares suffered a spectacular collapse on Tuesday, cratering as much as 40% in Paris and New York.
The clinical-stage drugmaker dropped highly anticipated Phase 3 maintenance data for its lead ulcerative colitis pill, obefazimod. The headline numbers revealed unmatched long-term efficacy, putting the company on a direct flight path to challenge big-pharma incumbents. However, the victory was instantly derailed by the appearance of scattered cancer cases concentrated exclusively in the high-dose cohort, spooking institutional investors and prompting an immediate, high-profile ******* yst downgrade.
The results from the global 44-week ABTECT maintenance study originally looked like a best-case scenario. Evaluating patients with moderately to severely active ulcerative colitis — many of whom were completely refractory, having failed multiple advanced biologic therapies — obefazimod proved to be an absolute clinical powerhouse. Patients on either the 25 mg or 50 mg once-daily oral doses achieved clinical remission rates of 50.8% and 51.3%, respectively. This stands in contrast to a meager 10.4% baseline for the placebo group, securing a placebo-adjusted remission rate of roughly 40%.
The financial wheels fell off, however, when investors opened the safety appendix. In the higher 50 mg treatment arm, investigators recorded individual diagnoses of prostate cancer, breast cancer, and colonic dysplasia — an abnormal cell progression that often acts as a precursor to malignant tumors. The high-dose cluster also flagged four separate non-melanoma skin cancer cases.
Abivax SA shares suffered a spectacular collapse on Tuesday, cratering as much as 40% in Paris and New York.
The clinical-stage drugmaker dropped highly anticipated Phase 3 maintenance data for its lead ulcerative colitis pill, obefazimod. The headline numbers revealed unmatched long-term efficacy, putting the company on a direct flight path to challenge big-pharma incumbents. However, the victory was instantly derailed by the appearance of scattered cancer cases concentrated exclusively in the high-dose cohort, spooking institutional investors and prompting an immediate, high-profile ******* yst downgrade.
The results from the global 44-week ABTECT maintenance study originally looked like a best-case scenario. Evaluating patients with moderately to severely active ulcerative colitis — many of whom were completely refractory, having failed multiple advanced biologic therapies — obefazimod proved to be an absolute clinical powerhouse. Patients on either the 25 mg or 50 mg once-daily oral doses achieved clinical remission rates of 50.8% and 51.3%, respectively. This stands in contrast to a meager 10.4% baseline for the placebo group, securing a placebo-adjusted remission rate of roughly 40%.
The financial wheels fell off, however, when investors opened the safety appendix. In the higher 50 mg treatment arm, investigators recorded individual diagnoses of prostate cancer, breast cancer, and colonic dysplasia — an abnormal cell progression that often acts as a precursor to malignant tumors. The high-dose cluster also flagged four separate non-melanoma skin cancer cases.
2 days ago
