Rallybio (RLYB) said Tuesday that the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency approved its applications for a phase 2 study of RLYB212 in pregnant women at higher risk of developing HPA-1a alloimmunization, which can lead to fetal and neonatal alloimmune thrombocytopenia.
With the approvals, the company said it intends to initiate screening of participants in Q4.
Rallybio said the phase 2 dose confirmation study will evaluate the safety and pharmacokinetics of RLYB212 in a total of eight pregnant women in Belgium, the Netherlands, Norway, Sweden, and the UK.
Shares of the company were up 1.9% in recent Tuesday trading.
Price: 1.06, Change: +0.02, Percent Change: +1.92
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