Rallybio Corp Stock Price, News & Analysis

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.

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.