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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 (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.
Rallybio (Nasdaq: RLYB) reported first quarter 2024 financial results, highlighting $94.2 million in cash as of March 31, 2024. The company is on track to start a Phase 2 trial for RLYB212 in pregnant women at higher risk of FNAIT in the second half of 2024. Rallybio also announced a collaboration with Johnson & Johnson, received an equity investment of $6.6 million, and is prioritizing its portfolio with a focus on RLYB212 and RLYB116. The company continues to progress in its clinical programs and expects to share additional data in the second half of 2024.
Rallybio (Nasdaq: RLYB) will present at the 2024 Citizens JMP Life Sciences Conference. Steve Uden, M.D., CEO, will participate in a fireside chat on May 14, 2024, at 11:30 a.m. ET in New York. The event will be live webcasted on Rallybio's website.
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