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Rallybio Corporation Common Stock (Symbol: RLYB) is a clinical-stage biotechnology company founded in January 2018 and based in Farmington, CT at the University of Connecticut’s Technology Incubation Program. The company is dedicated to identifying and accelerating the development of life-transforming therapies for patients with severe and rare disorders. Rallybio’s founders and team members boast a notable track record in pharmaceutical research and development, effectively leveraging their expertise to pursue promising drug candidates.
Rallybio’s core focus lies in developing treatments that target severe and often devastating diseases. Among its key projects is a program aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT), a rare and potentially life-threatening condition that can cause uncontrolled bleeding in fetuses and newborns. This program exemplifies Rallybio’s commitment to tackling unmet medical needs through innovative solutions.
The company’s approach involves working on drug candidates with strong biological rationales, utilizing well-validated therapeutic modalities such as small molecules, engineered proteins, and antibodies. By prioritizing robust clinical and commercial filters, Rallybio ensures that only the most promising assets are advanced through the development pipeline.
Recent achievements and ongoing projects highlight Rallybio’s progress and potential in the biotechnology sector. The company continues to build strategic partnerships and collaborations, enhancing its capabilities and resources for drug development. Financially, Rallybio remains focused on securing the necessary funding to support its ambitious research and development goals.
For investors and stakeholders, Rallybio Corporation represents a forward-thinking entity with a clear mission to improve patient outcomes through groundbreaking therapies. The company’s strategic location within a renowned technology incubation program underscores its innovative spirit and commitment to cutting-edge research.
Rallybio (RLYB) presented promising preclinical data for two pipeline candidates at the 66th ASH Annual Meeting. The first study showed that RLYB212 successfully prevented maternal alloimmunization and FNAIT in pregnant mice at doses of 1.01 or 5.05 µg/kg, with pups maintaining normal platelet counts and showing no signs of thrombocytopenia.
The second study demonstrated that RLYB332, a long-acting anti-matriptase-2 antibody, showed rapid and sustained effects on pharmacodynamic parameters including serum iron, UIBC, and transferrin saturation in humanized FcRn mice. The treatment was well-tolerated and showed superior results compared to comparator molecules, positioning it as a potential best-in-class therapeutic for iron overload diseases.
Rallybio (RLYB) announced new findings for RLYB116, its once-weekly subcutaneous C5 inhibitor for rare diseases. New biomarker analyses revealed that RLYB116 achieved greater complement inhibition in Phase 1 than initially reported, with the original assay overestimating free C5 levels by approximately ten-fold. The company completed manufacturing process enhancements expected to improve RLYB116's tolerability profile. A confirmatory clinical PK/PD study is planned for Q2 2025, involving two cohorts testing weekly doses of 150mg and 225mg over 4 weeks with a 10-week follow-up period.
Rallybio announced the publication of a manuscript detailing target-mediated drug disposition (TMDD) modeling used to determine RLYB212 dosing for pregnant women. The model incorporates pregnancy-related physiological changes and will be evaluated in their recently initiated Phase 2 clinical trial. RLYB212 is being developed to prevent alloimmunization in pregnant women and eliminate FNAIT risk in fetuses and newborns. The company is also conducting a natural history study, which has screened over 13,000 pregnant women as of November 1, 2024.
Rallybio (Nasdaq: RLYB), a clinical-stage biotech company focused on rare disease therapies, has announced its upcoming participation in the Evercore ISI HealthCONx Conference. Stephen Uden, M.D., CEO of Rallybio, will engage in a fireside chat on Wednesday, December 4, 2024 at 12:30 p.m. ET in Coral Gables, FL. The presentation will be available via live webcast through Rallybio's website, with a replay accessible for 30 days afterward.
Rallybio (Nasdaq: RLYB) announced a webcast to provide updates on RLYB116, their once-weekly subcutaneously injected C5 inhibitor being developed for complement-mediated diseases. The webcast, scheduled for December 2, 2024, at 8:30 AM ET, will cover manufacturing process improvements, biomarker characterization analyses, and future program plans. The presentation will be accessible through Rallybio's investor website, with materials remaining available for 30 days afterward.
Rallybio (RLYB) has initiated a Phase 2 clinical trial for RLYB212, targeting pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). The single-arm trial will evaluate pharmacokinetics and safety, with screening now underway for the first sentinel participant. The study will enroll eight participants across three stages: one sentinel pregnant woman, followed by Cohort 1 with three women, and Cohort 2 with four women. RLYB212 will be administered subcutaneously starting at Gestational Week 16 and continuing every 4 weeks until birth. The trial will be conducted across sites in Belgium, the Netherlands, Norway, Sweden, and the United Kingdom.
Rallybio (RLYB) reported Q3 2024 financial results with a net loss of $11.5 million ($0.26 per share), compared to $18.4 million loss in Q3 2023. Revenue was $0.3 million, with cash position of $75.1 million providing runway into mid-2026. The company received CTA approvals for RLYB212 Phase 2 clinical trial, with screening expected to begin in Q4 2024. R&D expenses decreased to $8.2 million from $13.3 million, while G&A expenses reduced to $4.1 million from $6.1 million year-over-year, primarily due to workforce reduction and lower development costs.
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.
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