Rare Disease-Focused Rallybio Inks Development Pact With Johnson & Johnson, Stock Shoots Higher

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 received an equity investment of $6.6 million from Johnson & Johnson Innovation.

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

Rallybio 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 will provide funding for Rallybio to raise awareness of Johnson & Johnson’s FNAIT clinical program in connection with Rallybio’s ongoing FNAIT natural history study. 

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

Rallybio 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 is conducting a Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn, in pregnant individuals who are already alloimmunized. 

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

In November 2023, Rallybio 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.

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