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.
Rallybio (Nasdaq: RLYB) has received approval for clinical trial applications from the EMA and MHRA for a Phase 2 trial of RLYB212 in pregnant women at higher risk of HPA-1a alloimmunization and FNAIT. The trial, set to begin screening in Q4 2024, will be conducted across five European countries and will evaluate eight pregnant women. The single-arm study will assess pharmacokinetics and safety of RLYB212, a monoclonal anti-HPA-1a antibody, with subcutaneous administration starting at Gestational Week 16 and continuing every 4 weeks through parturition.
Rallybio (Nasdaq: RLYB) presented nonclinical data at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting, demonstrating ENPP1 inhibition as a potential therapeutic approach for hypophosphatasia (HPP). The study, using an early lead ENPP1 inhibitor (REV101) in a mouse model of later-onset HPP, showed promising results:
1. Oral dosing lowered PPi by 30%
2. Improved mineralization of long and vertebrate bones
3. ENPP1 inhibition was safe and well-tolerated
Rallybio and Exscientia plc (Nasdaq: EXAI) are developing an improved ENPP1 inhibitor for HPP treatment, with a development candidate expected to be nominated in Q4 2024. This approach could potentially address the unmet need in HPP patients, particularly adults.
Rallybio (Nasdaq: RLYB) will present full data from an epidemiological analysis at the American Society of Human Genetics (ASHG) 2024 Annual Meeting in Denver, CO. The analysis quantifies the proportion of women across diverse populations at higher risk of a fetal and neonatal alloimmune thrombocytopenia (FNAIT)-impacted pregnancy.
Key findings include:
- Women at higher risk for FNAIT are more prevalent than previously estimated
- Risk extends beyond Caucasian populations
- Highest risk found in Ashkenazi Jewish (0.65%), non-Finnish European (0.64%), and Middle Eastern (0.62%) populations
- Significant risk also found in Caribbean Hispanic (0.33%) and African/African American (0.28%) populations
The analysis suggests over 30,000 pregnancies annually in North America and major European countries are at higher risk for FNAIT, representing a 40% increase from prior estimates and a $1.6 billion commercial opportunity.
Rallybio (Nasdaq: RLYB), a clinical-stage biotech company, will present full data from an epidemiological analysis at the NORD Rare Diseases & Orphan Products Breakthrough Summit from October 20-22, 2024, in Washington DC. The analysis quantifies the proportion of women across diverse populations at higher risk of a fetal and neonatal alloimmune thrombocytopenia (FNAIT)-impacted pregnancy.
CEO Stephen Uden emphasized the significance of this data, stating it provides the first clear evidence that non-Caucasian populations can carry a higher risk for FNAIT. This aligns with the summit's theme of 'Equitable Access to Innovation'. The poster will be available on Rallybio's website after the conference.
Rallybio (Nasdaq: RLYB), a clinical-stage biotechnology company, has been named an Innovation Honoree in the 2024 Fierce 50 list by Fierce Life Sciences and Fierce Healthcare. The list recognizes 50 individuals and companies driving advancements in medicine and shaping the future of biopharma and healthcare.
Rallybio, founded in 2018, focuses on developing therapies for rare diseases, with an initial emphasis on maternal-fetal health and diseases of complement dysregulation. Their lead program, RLYB212, targets the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT), a condition affecting over 30,000 pregnancies annually.
The company plans to initiate a Phase 2 trial for RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in Q4 2024. Additionally, Rallybio is conducting an FNAIT natural history study to provide data for a planned Phase 3 trial.
Rallybio (Nasdaq: RLYB) has published Phase 1 proof-of-concept study results for RLYB212, a novel monoclonal anti-HPA-1a antibody, in Thrombosis and Haemostasis. The study demonstrated that RLYB212 rapidly clears HPA-1a positive platelets, a important step in preventing alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Both tested doses (0.09 mg and 0.29 mg) met the prespecified criteria of ≥90% reduction in mean platelet elimination half-life compared to placebo. The drug was generally well-tolerated with no serious adverse events reported. Rallybio is on track to initiate a Phase 2 dose confirmation trial in pregnant women at higher risk for FNAIT in Q4 2024.
Rallybio (Nasdaq: RLYB), a clinical-stage biotechnology company focused on rare diseases, has announced its participation in two upcoming investor conferences. The company will be present at:
1. The 2024 Wells Fargo Healthcare Conference in Everett, MA on September 5, 2024. CEO Stephen Uden will participate in a fireside chat at 3:45 p.m. ET.
2. The H.C. Wainwright 26th Annual Global Investment Conference in New York, NY on September 10, 2024. Dr. Uden will present a corporate overview at 11:00 a.m. ET.
Live webcasts of both presentations will be available on Rallybio's website, with replays accessible for 30 days afterward.
Rallybio (Nasdaq: RLYB) reported Q2 2024 financial results and business updates. Key highlights include:
1. On track to initiate RLYB212 Phase 2 trial for FNAIT in Q4 2024.
2. $88.6 million cash position, providing runway into mid-2026.
3. Collaboration with Momenta Pharmaceuticals, including $6.6 million equity investment and $0.5 million upfront payment.
4. Epidemiological analysis revealed increased FNAIT risk, with over 30,000 pregnancies at higher risk annually.
5. Q2 2024 financial results: $0.3 million revenue, $12.9 million R&D expenses, $4.4 million G&A expenses, and $16.2 million net loss ($0.37 per share).
The company continues to advance its RLYB212, RLYB116, and preclinical programs, with several milestones expected in the coming quarters.
Rallybio (Nasdaq: RLYB), a clinical-stage biotechnology company focusing on rare diseases, announced that its Chief Financial Officer, Jonathan Lieber, will present at the 2024 Jones Healthcare Seaside Summit. The presentation is scheduled for July 15, 2024, at 8:00 a.m. PT (11:00 a.m. ET) in Encinitas, CA.
A live webcast of the presentation will be available on Rallybio's website, with an archived replay accessible for 30 days after the event.
Rallybio has announced the results of a large-scale epidemiological analysis on fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk across racially and ethnically diverse populations. The analysis, utilizing large genomic datasets, reveals that the proportion of pregnancies at higher risk for FNAIT is significantly higher than previously estimated, especially among Caucasian and Hispanic White populations.
The company estimates that over 30,000 pregnancies annually in North America and Europe are at higher risk for FNAIT, representing a 40% increase from prior estimates. This new data suggests that the addressable market for Rallybio's RLYB212 treatment could exceed $1.6 billion. The company plans to start a Phase 2 dose confirmation study of RLYB212 in pregnant women at higher risk for FNAIT in the second half of 2024.
Complete data from the study will be presented in Q4 2024. Rallybio also continues to conduct a non-interventional FNAIT natural history study, having screened approximately 10,000 pregnant women as of May 1, 2024.
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