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AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice
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.
Fantasy Baseball 2026: Winners and Losers From Week 12
The Pittsburgh Pirates lost a game in Colorado because of a cleat. The cleat of pinch-runner Billy Cook grazed third baseman Kyle Karros’s glove on a slow ground ball that would have otherwise tied the game. The call gave Paul Skenes a loss instead of a no-decision and surely fantasy baseball results were harmed by the call, which was the actual correct call.
MLB second basemen power rankings entering week 12
MLB has completed 11 weeks of the 2026 season. Certain players are having great seasons, but injuries are starting to affect some of the game’s best players. Heading into week twelve, here are the top ten second basemen around the…
Giants-Colts named one of NFL's best 'revenge games' in 2026
A Week 12 matchup between the New York Giants and Indianapolis Colts has been tabbed as one of the NFL's best "revenge games" in 2026.
Robbinsville's Kynadee Spencer tops girls spring sports playoff top performers
Robbinsville's Kynadee Spencer powered the Black Knights to a regional final, leading Week 12 WNC high school spring sports girls top performers.
Mitchell's Bryce Miller leads boys spring sports playoff top performers
Mitchell's Bryce Miller won the 2A boys golf individual championship to lead Week 12 WNC boys high school spring sports top performers.
College baseball rankings for Week 12: Updated USA TODAY Sports Coaches Poll, top 25 polls
Here's an updated look at the USA TODAY Sports College Baseball Coaches Poll for Week 12 and more.
This Week in Gaming (Week 12)
Welcome to week 12 and a jam cram packed week of rather big new releases. We kick off this week with a AAA release which is an open-world action-adventure that supposedly takes place in a desert, yet apparently not at all. This is followed by a very blocky looking RPG, several deadly sins, a cube of...