Rallybio Corporation - Common Stock (RLYB)

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that the first participant has been dosed in the Phase 2 trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK and safety data at the time of delivery expected in the third quarter of 2025.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today highlighted its 2024 accomplishments and announced its anticipated key milestones for 2025.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the presentation of two posters highlighting promising preclinical data for pipeline candidates RLYB212 and RLYB332 at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 7–10, 2024 in San Diego, California.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced results of new biomarker characterization analyses and data from the recently completed manufacturing process enhancements for RLYB116, the Company’s innovative, once-weekly, small volume, subcutaneously injected C5 inhibitor in development for the treatment of patients with complement-mediated diseases. Based on this recently completed work, Rallybio believes that RLYB116 has the potential to be a best-in-class C5 inhibitor and intends to initiate a confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the publication of a manuscript titled, “Informing Pregnancy Dose via Target-Mediated Drug Disposition Modeling and Simulations for a Recombinant Human Monoclonal Antibody,” in a special pregnancy themed issue of Clinical Pharmacology and Therapeutics: Pharmacometrics & Systems Pharmacology.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that Stephen Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Evercore ISI HealthCONx Conference on Wednesday, December 4, 2024 at 12:30 p.m. ET in Coral Gables, FL.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that the Company will host a webcast to provide a program update on RLYB116, its innovative, once-weekly, small volume, subcutaneously injected C5 inhibitor in development for the treatment of patients with complement-mediated diseases. The webcast will take place on Monday, December 2 at 8:30 AM Eastern Time and will review recent manufacturing process enhancements, biomarker characterization analyses, and the Company’s future plans for the program.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the initiation of its Phase 2 clinical trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Screening is now underway to identify the first (sentinel) pregnant woman for enrollment in the Phase 2 trial.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported third quarter financial results for the period ended September 30, 2024, and provided an update on recent company developments.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the approval of its clinical trial applications (CTAs) for a Phase 2 clinical trial of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). With these approvals from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Rallybio will begin to activate Phase 2 clinical sites and expects to initiate screening of participants in the fourth quarter of 2024.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that nonclinical data demonstrating ENPP1 inhibition as a therapeutic approach for the treatment of patients with hypophosphatasia (HPP) was presented at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. ASBMR is being held September 27 – 30, 2024 in Toronto, Canada.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that full data from an epidemiological analysis quantifying the proportion of women across diverse populations at higher risk of a fetal and neonatal alloimmune thrombocytopenia (FNAIT)-impacted pregnancy will be presented at the American Society of Human Genetics (ASHG) 2024 Annual Meeting to be held November 5 – 9, 2024 in Denver, CO.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that full data from an epidemiological analysis quantifying the proportion of women across diverse populations at higher risk of a fetal and neonatal alloimmune thrombocytopenia (FNAIT)-impacted pregnancy will be presented at the NORD Rare Diseases & Orphan Products Breakthrough Summit to be held October 20 – 22, 2024 in Washington DC.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that Fierce Life Sciences and Fierce Healthcare has named Rallybio an Innovation Honoree as part of the 2024 Fierce 50 list. The Fierce 50 showcases 50 individuals and companies driving advancements in medicine, fostering innovation, and shaping the future of biopharma and healthcare.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that data from the Phase 1 proof-of-concept study of RLYB212, a novel monoclonal anti-HPA-1a antibody in development for the prevention of maternal alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT), were published in Thrombosis and Haemostasis. Top-line results from this study were previously presented at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in 2023.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced its participation in the following upcoming investor conferences:

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported second quarter financial results for the period ended June 30, 2024, and provided an update on recent company developments.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that Jonathan Lieber, Chief Financial Officer of Rallybio, will present a corporate overview at the 2024 Jones Healthcare Seaside Summit on July 15, 2024 at 8:00 a.m. PT (11:00 a.m. ET) in Encinitas, CA.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported topline results from an epidemiological analysis of large genomic datasets evaluating the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in diverse ancestries. Data from this analysis confirmed Caucasian populations as having the greatest proportion of women with the genetic markers for higher FNAIT risk (HPA-1a negative, HLA-DRB3*01:01 positive). Additionally, data from this analysis provides, for the first time, robust evidence quantifying the proportion of women in non-Caucasian ancestries that carry the genetic markers for higher FNAIT risk.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported first quarter financial results for the period ended March 31, 2024 and provided an update on recent company developments.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that Steve Uden, M.D., Chief Executive Officer of Rallybio, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Tuesday, May 14, 2024 at 11:30 a.m. ET in New York, NY.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced the presentation of results from a fetal and neonatal alloimmune thrombocytopenia (FNAIT) systematic literature review and meta-analysis at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting, which is taking place in New Orleans, LA. The results of this research found that, in a pooled analysis of 198,062 pregnant women, 2.2% were HPA-1a negative and 32.3% of these women were also HLA-DRB3*01:01 positive and therefore at ~25-fold higher risk for alloimmunization. These rates are consistent with Rallybio’s current estimate of annual at-risk pregnancies and translate to tens of thousands of fetuses and newborns at risk each year for the potentially devastating consequences of FNAIT.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a collaboration with Johnson & Johnson1 to support the development of complementary therapeutic approaches aimed at reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). In addition, Rallybio received an equity investment of $6.6 million from Johnson & Johnson Innovation – JJDC, Inc.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced that data from a systematic literature review assessing the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk among pregnant mothers will be presented at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting in New Orleans from April 15th to 18th. Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody designed to prevent alloimmunization in at-risk pregnant mothers, thereby eliminating the risk of FNAIT and its potentially devastating consequences in fetuses and newborns.

Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent program and corporate developments.