AbCellera gains Health Canada nod for AD antibody trial

Published 30/05/2025, 18:06
AbCellera gains Health Canada nod for AD antibody trial

VANCOUVER - AbCellera Biologics Inc. (NASDAQ:ABCL) has received authorization from Health Canada to proceed with a Phase 1 clinical trial for its investigational antibody medicine, ABCL575, designed to treat moderate-to-severe atopic dermatitis (AD). The approval came in the form of a No Objection Letter (NOL) in response to the company’s Clinical Trial Application (CTA). According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 10.15, providing adequate resources for clinical development.

The upcoming Phase 1 study, set to commence in the third quarter of 2025, will assess the safety and pharmacokinetics of ABCL575 when administered subcutaneously to healthy participants. ABCL575, a monoclonal antibody, targets the OX40 ligand (OX40L), a known regulator of inflammatory pathways in AD. It has been engineered for Fc-silencing and extended half-life, aiming to offer less frequent dosing compared to other molecules currently in clinical stages. The company’s development efforts come at a crucial time, as InvestingPro analysis shows revenue declined by 35.4% in the last twelve months, highlighting the need for new product development.

Preclinical studies have demonstrated that ABCL575 has a potent inhibitory effect on T cell-mediated inflammatory pathways and exhibits favorable tolerability. The expected extended in vivo half-life could differentiate it from existing treatment options for AD.

AbCellera’s platform, which combines technology and data science with interdisciplinary teams, focuses on discovering and developing antibody medicines for multiple therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. The company is dedicated to advancing a pipeline of first-in-class and best-in-class programs, both independently and with partners.

The information regarding the anticipated clinical trial and the properties of ABCL575 is based on a press release statement from AbCellera Biologics Inc. The company cautions that forward-looking statements involve risks and uncertainties and that actual results could differ materially from those projected. AbCellera has committed to no obligation to update any forward-looking statements unless required by law. Trading near its 52-week low, AbCellera’s stock currently appears undervalued according to InvestingPro Fair Value metrics. For deeper insights into AbCellera’s financial health and growth potential, including 10+ additional ProTips and comprehensive valuation analysis, investors can access the full Pro Research Report on InvestingPro.

In other recent news, AbCellera Biologics has announced the initiation of a Phase 1 clinical trial for its investigational drug, ABCL635, after receiving approval from Health Canada. This trial will evaluate the drug’s safety and effectiveness in treating vasomotor symptoms in postmenopausal women. In financial developments, AbCellera reported a decline in revenue for the fourth quarter of 2024, with earnings showing $5.1 million in revenue and a net loss of $0.12 per share, down from the previous year’s $9.2 million revenue and $0.16 net loss per share. For the full year, revenues fell to $28.8 million from $38.0 million in 2023, with a net loss per share widening to $0.55.

In legal news, AbCellera secured a favorable ruling from the United States Court of Appeals, which upheld the validity of its patent on microfluidic devices. This decision is part of ongoing litigation with Bruker Cellular Analysis. On the research front, AbCellera presented promising preclinical data for its prostate cancer therapy, showing significant tumor cell killing activity. Analyst opinions on AbCellera’s stock varied, with Truist Securities cutting the price target to $10 while maintaining a Buy rating, and Benchmark maintaining a Hold rating without a price target change. These developments underscore AbCellera’s ongoing transition into a clinical-stage company, with investors closely watching its progress.

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