Rallybio Corporation ( RLYB ) shares are trading higher after the company announced a collaboration with Johnson & Johnson ( JNJ ) to support the development of complementary therapeutic approaches aimed at reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). 

FNAIT is a rare immune disorder that occurs when the baby’s platelets are attacked and destroyed by the mother’s immune cells in her bloodstream.

In addition, Rallybio ( RLYB ) received an equity investment of $6.6 million from Johnson & Johnson Innovation.

Rallybio ( RLYB ) is developing RLYB212, a human monoclonal anti-HPA-1a antibody designed to prevent pregnant individuals from alloimmunizing. 

Rallybio ( RLYB ) is on track 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 2024.

Under this collaboration, Johnson & Johnson ( JNJ ) will provide funding for Rallybio ( RLYB ) to raise awareness of Johnson & Johnson’s FNAIT clinical program in connection with Rallybio’s ongoing FNAIT natural history study. 

Rallybio ( RLYB ) is also eligible to receive additional payments under the collaboration.

Rallybio ( RLYB ) says RLYB212 is the only investigational therapy currently reported to be in clinical development to address the needs of pregnant individuals at risk of FNAIT who have not alloimmunized.

Johnson & Johnson ( JNJ ) is conducting a Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn, in pregnant individuals who are already alloimmunized. 

Rallybio ( RLYB ) is currently conducting a natural history study designed to provide a contemporary dataset for HPA-1a alloimmunization.

In November 2023, Rallybio ( RLYB ) revealed preliminary data from the completed multiple-dose cohort of the Phase 1 safety and pharmacokinetics (PK) study for RLYB212.

The preliminary data demonstrated that multiple-dose PK was consistent within and between subjects.

The preliminary data and the company’s clinical pharmacology modeling predictions support a once-monthly dosing regimen for the planned Phase 2 study. RLYB212 was observed to be generally well-tolerated, with no reports of injection site reactions or serious adverse events.

Price Action: RLYB shares are up 106.10% at $3.38 on the last check Thursday.