Proactive Investors - Rallybio announced it is collaborating with Johnson & Johnson (NYSE:JNJ) on the development of therapies aimed at reducing the risk of a rare fetal disease called fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Shares of the biotechnology company soared on the announcement, adding 69.3% at $2.76 late morning on Thursday.
FNAIT is a rare and potentially life-threatening disease that can cause uncontrolled bleeding in fetuses and newborns.
Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody designed to prevent pregnant individuals from alloimmunizing and therefore eliminating the risk of FNAIT.
It plans to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of the year.
As part of the collaboration, Rallybio will receive a $6.6 million equity investment from J&J’s venture capital arm.
Funds will be used to raise awareness of J&J’s FNAIT clinical program in connection with Rallybio’s ongoing FNAIT natural history study.
The natural history study will provide a dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population intended to support a future RLYB212 registration study.
Meanwhile, J&J is carrying out Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn in pregnant individuals who are already alloimmunized, meaning preventative treatment with RLYB212 would not be appropriate for these patients.
"Our complementary approaches, if successful, would ensure that pregnant individuals at risk of developing FNAIT have a potential treatment option, regardless of their alloimmunization status,” Rallybio CEO Dr Stephen Uden said in a statement.
“Together, we can more effectively and expeditiously drive awareness of FNAIT, emphasize the importance of screening pregnant individuals for their risk of developing FNAIT, and advance our complementary therapeutic approaches.”