Rallybio Corporation ((RLYB)) announced an update on their ongoing clinical study.
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Rallybio Corporation is conducting a Phase 2 study titled A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization. The study aims to assess the pharmacokinetics and safety of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal/neonatal alloimmune thrombocytopenia (FNAIT). This research is significant as it addresses a crucial need for preventive treatment in this vulnerable population.
The intervention being tested is RLYB212, a subcutaneous injection of an anti-(integrin beta-3) human monoclonal antibody. This drug is designed to prevent HPA-1a alloimmunization, potentially reducing the risk of FNAIT in newborns.
The study follows an interventional design with a single-group model and no masking, focusing on prevention. It is a multicenter, open-label study, meaning all participants receive the same treatment, and both researchers and participants know the treatment being administered.
The study commenced on November 21, 2024, with an anticipated duration of 44 weeks per participant, including screening and follow-up phases. The last update was submitted on June 25, 2025, indicating ongoing progress.
The successful development of RLYB212 could positively impact Rallybio’s stock performance by enhancing its portfolio with a novel treatment for a significant unmet medical need. This could also influence investor sentiment positively, given the potential market for such a treatment. Competitors in the maternal-fetal health sector may need to consider similar innovations to stay competitive.
The study is currently ongoing, with further details available on the ClinicalTrials portal.