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Rallybio Corporation (NASDAQ: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the completion of dosing of the first cohort in the Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) study evaluating RLYB116, the Company's innovative, once-weekly, small volume, subcutaneously injected C5 inhibitor.
"We are encouraged by the data generated to date in this confirmatory multiple ascending dose study and these results reinforce our confidence in the RLYB116 program," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "We have completed the dosing of cohort 1 and the pharmacokinetic and pharmacodynamic profile is consistent with our predictions based on the previous Phase 1 study. More importantly, we have observed a significantly cleaner safety profile. We believe the improved tolerability is due to manufacturing enhancements and supports dose escalation to cohort 2. We look forward to sharing the data from this study in the fourth quarter of 2025."
The single-blind multiple ascending dose Phase 1 confirmatory PK/PD study of RLYB116 (NCT06797375) is designed to demonstrate complete and sustained complement inhibition with favorable tolerability in healthy volunteers. The study is evaluating a 4-week treatment duration that includes two cohorts of eight participants each, randomized 3 to 1 to receive either RLYB116 or placebo once weekly. Cohort 1 evaluated dosing of 150 mg and Cohort 2 will evaluate dosing of up to 300 mg. The study includes a 10-week follow-up period after the conclusion of treatment. In June 2025, Rallybio announced that the initial indication focus for RLYB116 will be on two hematologic conditions with significant unmet need: immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS). These indications represent a combined market opportunity of $5 billion.
Posted In: RLYB
