AbCellera's ABCL635 Delivers Strong Phase 2 Data; Stock Jumps 33%
(RTTNews) - AbCellera Biologics Inc. (ABCL) announced positive top-line results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635, an investigational NK3R antagonist antibody for moderate-to-severe vasomotor symptoms due to menopause.
The study met its primary efficacy endpoints achieving statistically significant reductions in both frequency and severity of hot flashes at week 4 compared to placebo after a single subcutaneous 600 mg dose. Patients receiving ABCL635 experienced an average reduction of 8.8 moderate-to-severe events per day versus 3.5 for placebo, representing a placebo-adjusted difference of 5.3 (p0.001). This translated into an 83% reduction in frequency compared to 33% for placebo.
Severity scores also improved, with a mean reduction of 1.4 points versus 0.3 for placebo, yielding a placebo-adjusted difference of 1.1 (p0.001). The mean percent reduction in severity was 58% for ABCL635 compared to 12% for placebo. Meaningful improvements were observed in sleep quality and in patient global impression of change.
ABCL635 was well tolerated, with no serious adverse events or discontinuations. The most common side effects were headache, fatigue, and injection site reactions, occurring more frequently than in the placebo group.
Dr. JoAnn V. Pinkerton of the University of Virginia noted that the four-week data set a new efficacy benchmark for reducing hot flashes and improving sleep, adding that if validated in Phase 3, ABCL635 could provide a convenient, non-hormonal treatment option. AbCellera's Chief Medical Officer Sarah Noonberg highlighted the milestone as a breakthrough in women's health, demonstrating best-in-class relief with a single dose.
The Phase 2 trial enrolled 92 postmenopausal women experiencing an average of 10 hot flashes per day, randomized 1:1 to ABCL635 or placebo.
This readout positions ABCL635 as a potential long-acting, non-hormonal therapy for millions of women affected by moderate-to-severe vasomotor symptoms, with Phase 3 validation expected to determine its path toward regulatory approval.
ABCL has traded between $2.74 and $8.44 over the past year. The stock closed Friday's trading (August 7, 2026) at $6.93, up 6.13%. In pre-market trading the stock is at $9.21, up 33.04%.
