Clinical trialsCompany release

AbCellera reports positive Phase 2 week-4 data for ABCL635 in menopausal hot flashes

🇺🇸 AbCellera Biologics Inc. (ABCL) · Mon 09 Nov 2026

The once-monthly antibody cut moderate-to-severe vasomotor symptom frequency by 83% versus 33% with placebo, and the company reported no serious or Grade 3+ adverse events in treated patients.

AbCellera Biologics has announced positive top-line week 4 results from a Phase 2 study of ABCL635 in moderate-to-severe vasomotor symptoms associated with menopause, commonly known as hot flashes. The data appeared in the company's third-quarter 2026 business update, dated 9 November 2026.

ABCL635 is a once-monthly subcutaneous antibody, given at 600 mg in the study. According to the company, it reduced the frequency of vasomotor symptoms by 83%, compared with a 33% reduction in the placebo group.

On safety, AbCellera said no serious adverse events and no Grade 3 or higher adverse events occurred in the treated group. The headline of its announcement also states that no liver or gastrointestinal signals were seen. The summary available to VigiEye does not provide the size of the study, the full dosing schedule, the statistical analysis or the detailed adverse-event data.

AbCellera says it is discussing next steps with regulators and is working through the US Food and Drug Administration's Model-Informed Drug Development (MIDD) programme. The MIDD programme is the FDA's pilot route for sponsors to discuss the use of modelling and simulation approaches in development planning with the agency. The company has not set out, in the material reviewed, what a pivotal programme would look like or when it might begin.

What it means for your team

  • The data are top-line, company-reported and cover week 4 only; durability and longer-term safety remain to be shown.
  • The absence of liver and gastrointestinal signals is notable for pharmacovigilance teams tracking safety in this symptom area, but it rests on a limited dataset.
  • Regulatory teams should watch for details of the FDA MIDD interactions and any agreed Phase 3 design, as these will shape the development path.
  • Market-access teams should note the once-monthly subcutaneous format as a potential differentiator, though no pricing or timeline information has been given.

Company's press release (SEC filing): AbCellera Biologics Inc. ↗

Article written by VigiEye from the official source (AbCellera Biologics Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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