Welcome to our dedicated page for Rallybio news (Ticker: RLYB), a resource for investors and traders seeking the latest updates and insights on Rallybio stock.
Rallybio Corporation (NASDAQ: RLYB) is a clinical-stage biotechnology company whose news flow centers on the development of therapies for severe and rare diseases. Company press releases and SEC filings highlight progress across its pipeline, with particular emphasis on RLYB116, a differentiated C5 inhibitor being evaluated in a Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) study designed to demonstrate complete and sustained complement inhibition with favorable tolerability.
Investors following RLYB news can expect regular updates on clinical milestones for RLYB116, including cohort dosing, interim data, and the program’s initial focus on immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS), two hematologic conditions with significant unmet need. Rallybio also issues news on its preclinical programs, such as RLYB332, a long-acting monoclonal anti-matriptase-2 antibody for diseases of iron overload, and on the ENPP1 inhibitor program REV102 for hypophosphatasia (HPP), which originated from a joint venture with Recursion Pharmaceuticals.
RLYB news releases frequently cover financial results, cash runway guidance, and portfolio decisions, including the discontinuation of the RLYB212 program for fetal and neonatal alloimmune thrombocytopenia (FNAIT) based on Phase 2 pharmacokinetic data. Corporate and transaction updates, such as the sale of Rallybio’s interest in REV102 to Recursion for equity, milestones, and potential royalties, as well as workforce and cost-structure changes, are also disclosed.
This news page aggregates these company-issued updates, earnings announcements, and material event disclosures, offering a centralized view of Rallybio’s clinical progress, strategic transactions, and capital position for those tracking RLYB stock and its rare disease pipeline.
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Rallybio (Nasdaq: RLYB) and Candid Therapeutics have agreed to merge, with the combined company to operate as Candid Therapeutics (Nasdaq: CDRX). The deal includes an oversubscribed private Financing of over $505 million and pro-forma cash of approximately $700 million expected to fund operations through 2030.
The Transaction is expected to close in mid-2026, is subject to customary closing conditions, and pre-Transaction Rallybio equityholders are expected to own approximately 3.65% of the combined company.
Rallybio (Nasdaq: RLYB) reported positive Phase 1 PK/PD results for RLYB116, a once-weekly subcutaneous C5 inhibitor. At a 300 mg dose the drug achieved complete and sustained inhibition of terminal complement with a tolerability profile consistent with other subcutaneous biologics.
The single-blind multiple-ascending dose study enrolled two cohorts (150 mg, 300 mg) of eight participants each and included a 10-week follow-up. A Phase 2 study in immune platelet transfusion refractoriness is planned for 2H 2026 with potential topline data in 2027.
Rallybio (Nasdaq: RLYB) will effect a one-for-eight reverse stock split of its common stock, effective 12:01 a.m. ET on February 6, 2026, after stockholder approval on January 26, 2026. The split is intended to increase the per-share trading price to help satisfy Nasdaq Capital Market minimum listing requirements.
No fractional shares will be issued; stockholders will receive cash in lieu of fractions. Post-split shares will trade under the same symbol RLYB with a new CUSIP 75120L209. Computershare is acting as exchange and transfer agent.
Rallybio (Nasdaq: RLYB) reported Q3 2025 results and business updates on November 6, 2025. Key points: Rallybio received $20.0 million from the sale of its interest in REV102, completed dosing in Cohort 1 of the RLYB116 Phase 1 confirmatory PK/PD study and expects Cohort data in 4Q 2025. The company reported net income of $16.0 million ($0.36/share) for Q3 2025 versus a net loss of $11.5 million a year earlier. As of September 30, 2025, cash, cash equivalents and marketable securities totaled $59.3 million, and Rallybio expects runway through 2027. The company also reported lower R&D and G&A expenses versus Q3 2024 and provided an update on RLYB332 preclinical data.
Rallybio (Nasdaq: RLYB) has completed dosing of the first cohort in its Phase 1 confirmatory PK/PD study for RLYB116, a once-weekly subcutaneous C5 inhibitor. The study evaluates two cohorts over 4 weeks, with Cohort 1 receiving 150mg doses and Cohort 2 planned for up to 300mg.
Initial data shows improved tolerability attributed to manufacturing enhancements, with PK/PD profiles aligning with previous Phase 1 results. The company plans to advance to Cohort 2, with complete study results expected in Q4 2025.
RLYB116 is being developed for immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS), representing a $5 billion market opportunity.
Rallybio (Nasdaq: RLYB) has received a $12.5 million equity milestone payment from Recursion following the initiation of additional preclinical studies for REV102, a potential first-in-class oral ENPP1 inhibitor being developed for hypophosphatasia (HPP).
This payment is part of a previously announced agreement where Rallybio sold its interest in the REV102 program to Recursion for up to $25 million. The company remains eligible for an additional $5 million milestone payment upon Phase 1 clinical study initiation, plus low single-digit royalties on future net sales.
The non-dilutive capital extends Rallybio's cash runway through 2027, strengthening its financial position as it awaits topline data from the RLYB116 confirmatory PK/PD study.
Rallybio (NASDAQ:RLYB) reported Q2 2025 financial results and significant business updates. The company sold its interest in REV102 to Recursion Pharmaceuticals for up to $25 million, including a $7.5 million upfront equity payment. The deal extends cash runway into mid-2027.
Key financial metrics include a net loss of $9.7 million ($0.22 per share), reduced from $16.2 million in Q2 2024. R&D expenses decreased to $6.1 million from $12.9 million year-over-year. Cash position stands at $45.7 million as of June 30, 2025.
The company's lead program RLYB116 entered a confirmatory PK/PD study, with data readouts expected in Q3 and Q4 2025. However, Rallybio discontinued the RLYB212 program for FNAIT prevention due to inadequate dose concentration achievements in Phase 2 trials.
Rallybio (Nasdaq: RLYB) has agreed to sell its interest in REV102, a preclinical ENPP1 inhibitor program for hypophosphatasia (HPP), to Recursion Pharmaceuticals. The deal is valued at up to $25 million, including a $7.5 million upfront equity payment.
The transaction includes potential milestone payments of $12.5 million for initiating additional preclinical studies and $5 million for Phase 1 clinical study initiation. Rallybio will also receive low single-digit royalties on future net sales. The upfront payment extends Rallybio's cash runway into mid-2027.
REV102, developed through a joint venture between both companies, represents the first potential oral disease-modifying treatment for HPP and entered IND-enabling studies in early 2025.