AbCellera stock soars on ‘off the chart’ trial results from hot flash treatment for menopausal women

Shares of AbCellera Biologics Inc. ABCL-Q soared Monday to their highest level in 3½ years after the Vancouver antibody developer published human trial results showing its treatment for hot flashes is more effective and has fewer side effects than existing treatments.

The results suggest the drug, called ABCL635, could be a best-in-class nonhormonal therapy for women in menopause or undergoing hormone-suppressing cancer treatments, and it could generate US$1-billion-plus in annual sales, AbCellera said.

The study marks a significant milestone for AbCellera, which has emerged as Canada’s biotechnology industrial champion, heavily backed by the federal and provincial governments. The University of British Columbia spin-out sees it as a validation of its strategic shift three years ago to focus on developing its own drugs rather than discovering antibodies for others.

“Our vision has been to build Canada’s first global biotech company” that “can repeatedly invent, develop and commercialize breakthrough medicines,” AbCellera chief executive officer Carl Hansen told analysts during a conference call Monday. “Obviously nothing is certain, but today it sure looks like we’ve found our first winner.”

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AbCellera said that in a trial of 92 women conducted across Canada, ABCL635 delivered significant improvements in the frequency and severity of hot flashes compared with those taking a placebo. The women in the trial, aged 47 to 71, had experienced about 10 moderate to severe hot flashes a day beforehand. AbCellera said those who took the drug experienced a mean 83-per-cent reduction of hot flashes over the trial’s four-week span, compared with a 33-per-cent drop for those on the placebo.

Thirty-seven per cent of those taking the drug experienced no moderate or severe hot flashes, while 61 per cent experienced a 90-per-cent-plus reduction.

Those taking the drug experienced a 58-per-cent mean reduction in the severity of hot flashes, compared with 12 per cent in the placebo group. AbCellera plans to publish further data after 12 weeks.

AbCellera stock closed at US$9.34 on the Nasdaq Monday, up 34.8 per cent on the day. It is up 173 per cent this year.

The efficacy data are “practically off the chart on everything measured” and better than two other non-hormone hot flash therapies that recently entered the market – Astellas Pharma Inc.’s Veozah and Lynkuet by Bayer – Cantor Fitzgerald analyst Steve Seedhouse said in a note.

Mr. Seedhouse increased his stock price target to US$20 a share from US$12. He predicted AbCellera could command a premium price and ultimately dominate a market that the company estimates could be worth US$6-billion-plus annually.

“When I first viewed this data, my honest impression was ‘Wow,’” said Kelsey Mills, a clinical associate professor of obstetrics and gynecology with UBC who spoke on the AbCellera conference call. She was not involved in the trial, but said the results suggest the drug could prove far more appealing to patients than alternatives.

The Bayer and Astellas drugs need to be taken daily and accompanied by regular monitoring for potential liver toxicity. Gastrointestinal issues also affect some patients.

By contrast, ABCL635 is expected to be delivered once monthly by self-injection, similar to GLP-1 drugs such as Ozempic. Because the antibody is not processed by the liver, it has not shown any toxicity issues. Side effects in the trial were largely limited to temporary mild headaches and fatigue. Many patients experienced meaningful improvements to their sleep.

Dr. Mills said she saw “a lot of benefit to simplicity in terms of improving patient adherence and compliance” if women only need a monthly treatment and no continuing monitoring.

ABCL635 still must pass another, larger trial to gain regulatory approval, a considerable challenge that has thwarted many developers. But if it prevails, ABCL635 could be a significant new treatment option for women experiencing the debilitating effects of hot flashes, technically called vasomotor symptoms.

“As both a menopausal-aged woman and as an internal medicine physician, it is a true privilege to be advancing a therapy to address such a common, important and often overlooked and undertreated cause of diminished quality of life,” AbCellera chief medical officer Sarah Noonberg said on the conference call.

Hot flashes, or rapid flare-ups of heat and sweating, are a symptom of menopause that affects women after their ovaries stop producing estrogen. Many take hormone replacements, which used to be commonly prescribed but fell out of favour two decades ago after they were linked to cardiovascular disease and breast cancer. Demand has been rising, however, particularly since the U.S. Food and Drug Administration last year removed warnings for those side effects after some experts said the risks were overstated.

But hormone therapies don’t work for roughly 20 per cent of women and cause other side effects including bleeding. In response, a new class of drugs has emerged that block the activation of hot flashes by targeting receptors on brain neurons, including the drugs from Bayer, Astellas and AbCellera.

The latest trial results were announced six years after AbCellera developed a treatment for people hospitalized with the COVID-19 virus. Partner Eli Lilly & Co. secured emergency authorization to take the drug to market and AbCellera banked nearly US$1-billion in royalties.

But as revenues tailed off, so did its stock price after its December, 2020, initial public offering. AbCellera’s focus on churning out antibodies for others to develop didn’t excite investors. So in 2023, it began developing its own drugs, focusing on established areas where it could address unmet need with differentiated treatments, while spending relatively little on research and development.

AbCellera has moved quickly. ABCL635 entered clinical trials in July, 2025. The company is preparing to take two more antibodies into the clinical studies next year.

The successful result Monday “resets the narrative about the entire company,” Mr. Seedhouse said. “It’s hard to see this train slowing down.”