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NEW HAVEN, Conn. - Rallybio Corporation (NASDAQ: RLYB), a clinical-stage biotechnology company with a market capitalization of $32.36 million, has initiated a Phase 2 clinical trial for RLYB212, a potential treatment aimed at preventing a rare and potentially life-threatening condition known as fetal and neonatal alloimmune thrombocytopenia (FNAIT). According to InvestingPro data, the stock has experienced significant volatility, declining about 56% over the past year. The first participant has received a dose in a study that will examine the pharmacokinetics (PK) and safety of the therapy in pregnant women at risk for HPA-1a alloimmunization, which can cause FNAIT.
The trial’s sentinel participant’s PK and safety data are expected to be available in the second quarter of 2025, with additional data anticipated at the time of delivery in the third quarter of 2025. The study is designed to enroll a total of eight pregnant women across three stages, with the goal of preventing maternal alloimmunization and the severe complications associated with FNAIT. While the company maintains a strong liquidity position with a current ratio of 9.55 and more cash than debt on its balance sheet, InvestingPro analysis indicates the company is quickly burning through its cash reserves.
RLYB212 is an anti-HPA-1a monoclonal antibody administered subcutaneously, intended to prevent maternal alloimmunization by eliminating HPA-1a positive fetal platelets from the mother’s circulation. FNAIT occurs when there is an immune incompatibility between an HPA-1a-negative expectant mother and her HPA-1a-positive fetus, leading to the mother developing antibodies that can cross the placenta and destroy the fetus’ platelets, resulting in severe health consequences.
The trial will be conducted at multiple sites in Europe and includes secondary objectives such as assessments of pregnancy and neonatal/infant outcomes, as well as the occurrence of emergent HPA-1a alloimmunization. Rallybio’s CEO, Stephen Uden, M.D., expressed the company’s commitment to providing updates as they progress with the trial and continue their mission to develop safe and effective therapeutics for rare diseases.
Rallybio is a biotechnology firm focused on developing therapies for severe and rare diseases, with a pipeline that includes other clinical-stage programs and preclinical developments. The company’s stock, which tends to move counter to the market with a beta of -1.49, is currently considered undervalued by InvestingPro analysts. For detailed insights into Rallybio’s financial health, growth prospects, and 10+ additional ProTips, investors can access the comprehensive Pro Research Report available on InvestingPro. The information presented in this article is based on a press release statement from Rallybio Corporation.
In other recent news, Rallybio Corp has seen significant developments in its clinical trials and drug manufacturing processes. Following a recent webcast, H.C. Wainwright reaffirmed a Buy rating for Rallybio, highlighting the potential of the company’s drug candidate, RLYB116. The company has improved the manufacturing process for RLYB116, aiming to enhance the drug’s tolerability and increase complement inhibition. A Phase 1 trial for this drug is expected to begin in the second quarter of 2025, with results anticipated by year-end.
Simultaneously, Rallybio has initiated a Phase 2 clinical trial for RLYB212, a potential treatment for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), a rare condition affecting fetuses and newborns. The company has used a target-mediated drug disposition model to inform the dosing regimen for this trial. As of November 1, 2024, Rallybio has screened over 13,000 pregnant women as part of a study to understand the frequency of HPA-1a alloimmunization across diverse populations. These recent developments underscore Rallybio’s dedication to developing therapies for severe and rare diseases.
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