Business
Rallybio Reports Fourth Quarter and Full Year 2023 Financial Results
-- Received Protocol Assistance Feedback from European Medicines Agency on the Phase 2 Study for RLYB212; Company to Proceed Forward with Clinical Trial
About this update from Rallybio Corporation
[{"type":"text","content":"\n-- Received Protocol Assistance Feedback from European Medicines Agency on the Phase 2 Study for RLYB212; Company to Proceed Forward with Clinical Trial Application Process in Europe --\n\n\n-- Phase 2 Dose Confirmation Study for RLYB212 in Pregnant Women at Higher Risk for FNAIT Expected to Initiate in 2H 2024 --\n\n\n-- $109.9 million Cash, Cash Equivalents and Marketable Securities as of December 31, 2023; Provides Runway into Mid-2026 --\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent program and corporate developments.\n\n\n“We are encouraged by the continued progress we made across our portfolio throughout 2023. Following our February 2024 announcement regarding the prioritization of our portfolio and reorganization of our operations, we believe our existing capital will fund our revised operating plan into the middle of mid-2026 and intend to focus our efforts in 2024 on our clinical-stage programs, RLYB212 and RLYB116. We have received feedback from the European Medicines Agency for RLYB212 and are pleased to now move forward with the clinical trial application process in Europe where we will conduct the Phase 2 dose confirmation study for RLYB212 in pregnant women at higher risk for FNAIT. The Phase 2 study remains on track to initiate in the second half of 2024,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio.\n\n\nDr. Uden continued, “In parallel, the manufacturing work for RLYB116 is ongoing and we are encouraged by the data indicating the potential to achieve improved tolerability at higher doses. We expect to complete this work and provide an update on the development plan for RLYB116 in the second half of 2024. We also remain committed to advancing our preclinical programs to the next milestone and will seek alternative options to advance and or finance these programs with a goal of realizing the value of these programs.”\n\n\nRecent Business Highlights and Upcoming Milestones:\n\n\nCorporate Updates\n\n\nIn February 2024, Rallybio announced a prioritization of its portfoli...