This section highlights FDA-related milestones and regulatory updates for drugs developed by AbCellera Biologics (ABCL).
Over the past two years, AbCellera Biologics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ABCL575 and ABCL635. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ABCL575 - FDA Regulatory Timeline and Events
ABCL575 is a drug developed by AbCellera Biologics for the following indication: AbCellera announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L) that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABCL575
- Announced Date:
- May 30, 2025
- Indication:
- AbCellera announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L) that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions.
Announcement
AbCellera announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L) that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions.
AI Summary
AbCellera Biologics Inc. announced that it has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application (CTA) for ABCL575. This investigational antibody antagonist targets the OX40 ligand (OX40L), which plays a key role in inflammatory pathways related to moderate-to-severe atopic dermatitis (AD). The company is developing ABCL575 with the hope that it may benefit patients not only with AD, but also with other inflammatory and autoimmune conditions. The therapy has been engineered for an extended half-life and designed with an Fc-silenced modification for improved safety. AbCellera plans to begin a Phase 1 clinical trial in Q3 2025 to study the safety and pharmacokinetics of this treatment when administered subcutaneously in healthy participants.
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ABCL635 - FDA Regulatory Timeline and Events
ABCL635 is a drug developed by AbCellera Biologics for the following indication: For Vasomotor Symptoms Due to Menopause.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABCL635
- Announced Date:
- May 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- For Vasomotor Symptoms Due to Menopause
Announcement
AbCellera announced that it anticipates starting the Phase 1 clinical trial for ABCL635 in Q3 2025
AI Summary
AbCellera announced that it expects to start the Phase 1 clinical trial for its investigational drug ABCL635 in the third quarter of 2025. ABCL635 is developed as a non-hormonal treatment for moderate-to-severe vasomotor symptoms, which are hot flashes experienced during menopause. The upcoming Phase 1 trial will focus on testing the safety of the drug along with its pharmacokinetics and pharmacodynamics. The study will involve both healthy volunteers and postmenopausal women who experience these disruptive symptoms. This trial is an important step for AbCellera as it works to develop a long-acting treatment option that could help millions of women manage menopause-related symptoms. The initiation of the Phase 1 trial marks a significant milestone in advancing ABCL635 through the clinical development process.
Read Announcement- Drug:
- ABCL635
- Announced Date:
- May 14, 2025
- Indication:
- For Vasomotor Symptoms Due to Menopause
Announcement
AbCelleraannounced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL635, an investigational antibody antagonist targeting neurokinin 3 receptor (NK3R) that is being developed for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.
AI Summary
AbCellera announced that it has received a No Objection Letter (NOL) from Health Canada, which approves its Clinical Trial Application (CTA) for the investigational drug ABCL635. This antibody antagonist targets the neurokinin 3 receptor (NK3R) and is being developed as a non-hormonal treatment approach for moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, experienced during menopause.
The NOL allows AbCellera to advance ABCL635 into Phase 1 clinical trials, which are planned to begin in Q3 2025. During these trials, the company will evaluate the safety, pharmacokinetics, and pharmacodynamics of ABCL635 in both healthy participants and postmenopausal women. AbCellera hopes that this new treatment will provide a long-acting and effective solution to ease the disruptive symptoms of menopause, ultimately improving the quality of life for many women.
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