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Rallybio Highlights 2024 Accomplishments and Anticipated Milestones for 2025
– Dosing of Sentinel (First) Participant in RLYB212 Phase 2 Clinical Trial Expected in 2Q 2025 – – Initiation of RLYB116 Confirmatory PK/PD Study Expected in
About this update from Rallybio Corporation
[{"type":"text","content":"\n– Dosing of Sentinel (First) Participant in RLYB212 Phase 2 Clinical Trial Expected in 2Q 2025 –\n\n\n– Initiation of RLYB116 Confirmatory PK/PD Study Expected in 2Q 2025, with Data Anticipated in 2H 2025 –\n\n\n– REV102, an ENPP1 Inhibitor for the Treatment of Hypophosphatasia, to Enter IND-Enabling Studies in 2025 –\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today highlighted its 2024 accomplishments and announced its anticipated key milestones for 2025.\n\n\n“With our team’s innovation and execution throughout 2024, Rallybio is well positioned to create meaningful value in 2025,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “We are planning for key readouts from our RLYB212 and RLYB116 clinical programs and expecting important advancements in our REV102 program throughout the year. We believe these developments will provide further evidence of the value our programs can ultimately bring to patients. With these accomplishments and continued financial discipline, the Company is poised for significant momentum in 2025 and even greater success in the years to come.”\n\n\n2024 Accomplishments\n\n\nRLYB212\n\n\n\nObtained clinical trial application approvals and initiated the first-ever Phase 2 dose confirmation trial in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT)\n\n\n\nScreened more than 14,000 pregnant women through January 1, 2025 in the Company’s ongoing FNAIT natural history study\n\n\n\nPresented results of an epidemiological analysis demonstrating FNAIT risk across racially and ethnically diverse populations, indicating that more than 30,000 pregnancies each year are at higher risk for FNAIT, at the NORD Summit and ASHG\n\n\n\nPublished Phase 1b proof-of-concept results, in addition to the modeling and simulations that support the RLYB212 dose regimen for the Phase 2 trial\n\n\n\nRLYB116\n\n\n\nSuccessfully completed manufacturing process enhancements, which are expected to further improve the tolerability of RLYB116\n\n\n\nPresented biomarker characterization analyses indicating that RLYB116 led to a greater degree of complement inhibition in the Phase ...