AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice

Biotech AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice By Nick Paul Taylor Aug 10, 2026 8:24am AbCellera Menopause hot flashes Women's health AbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a women’s health market. The phase 2 clinical trial compared ABCL635, an antibody targeting NK3R, to placebo in patients with hot flashes caused by menopause. Investigators enrolled 92 postmenopausal women experiencing a mean of about 10 moderate or severe hot flashes per day.

By Week 4, the number of moderate or severe hot flashes had fallen by a mean of 8.8 on ABCL635 and by 3.5 on placebo. That statistically significant, placebo-adjusted reduction of 5.3 hit the trial’s primary endpoint. The level of efficacy also cleared the bar set by existing drugs.

While cross-trial comparisons can be misleading, AbCellera CEO Carl Hansen, Ph.D., had seen enough to start hyping the program. “We now view ABCL635 as a potential best-in-class non-hormonal therapy with strong differentiation against approved NK3R competitors across all important dimensions, including efficacy, safety, dosing and convenience,” Hansen said on a Monday morning conference call with investors to discuss the data. “We believe ABCL635 is now a highly de-risked program.” Last week, Hansen used AbCellera’s earnings call to set expectations for readout, with the CEO defining success as a clean safety profile and efficacy comparable to the two approved small molecules.

The data vaulted over that bar. Astellas linked (PDF) one of the small molecules, Veozah, to placebo-adjusted reductions in hot flash frequency of 2.1 and 2.6 at Week 4 of its two phase 3 trials. Bayer reported (PDF) placebo-adjusted reductions of 3.04 and 3.29 at Week 4 of pivotal studies for its small molecule, Lynkuet.

At 5.3, the placebo-adjusted reduction in AbCellera’s trial comfortably cleared the standard set by the incumbents. Veozah and Lynkuet came to market based on evidence of their ability to reduce the frequency and severity of hot flashes. AbCellera’s phase 2 study covered both endpoints, with the Canadian biotech reporting a mean reduction in severity of 1.4 points at Week 4 on ABCL635, compared to 0.3 points for placebo.

Again, the placebo-adjusted result compares favorably to data on Veozah and Lynkuet. Analysts shared Hansen’s enthusiasm for the data. The phase 2 results “firmly validate ABCL635 as a potentially best-in-class treatment,” BMO Capital Markets analysts said in a note to investors Monday.

ABCL635’s apparent efficacy edge “is likely attributable to the higher dosing/target engagement the asset is able to reach vs. the oral agents due to its wider therapeutic index,” the analysts added. The analysts, who model $2.3 billion in unadjusted peak sales for ABCL635, flagged the safety profile as another positive of the phase 2 readout.

While Veozah carries a boxed warning for liver damage, nobody on ABCL635 in the phase 2 trial had elevated liver enzymes or bilirubin values. If replicated in phase 3, the lack of a liver signal could allow approval without the monitoring requirements imposed on Veozah. Investors appeared equally enthused, sending AbCellera's stock up 32% to $9.21 in premarket trading Monday from a Friday closing price of $6.93.

Next, AbCellera will collect the Week 12 data and talk to its advisors about further development. The results open up “a wide variety of possibilities of how we might take this forward into phase 3 studies to truly maximize the value of the asset and make sure that ABCL635 is able to demonstrate its differentiation potential,” Sarah Noonberg, M.D., Ph.D., AbCellera’s chief medical officer, told investors. AbCellera Menopause hot flashes Women's health Bayer Astellas Biotech Clinical Data