NEW HAVEN, Conn. - Rallybio Corporation (NASDAQ: RLYB), a biotech firm specializing in therapies for rare and severe diseases, announced a collaboration today with Johnson & Johnson to advance treatments for fetal and neonatal alloimmune thrombocytopenia (FNAIT). The partnership includes a $6.6 million equity investment from Johnson & Johnson Innovation – JJDC, Inc. into Rallybio.
Rallybio is developing RLYB212, a human monoclonal anti-HPA-1a antibody, which is intended to prevent the condition in at-risk pregnancies by stopping mothers from developing alloantibodies that can lead to FNAIT.
This condition can cause severe bleeding in fetuses and newborns due to an immune reaction against the baby's platelets. Rallybio plans to begin a Phase 2 study for RLYB212 in the latter half of 2024.
As part of the collaboration, Johnson & Johnson will fund awareness initiatives for FNAIT in conjunction with Rallybio's ongoing study of the disease's natural history. This study aims to gather current data on the frequency of HPA-1a alloimmunization across diverse populations to support future regulatory submissions for RLYB212.
Johnson & Johnson is also conducting a Phase 3 study of nipocalimab, another monoclonal antibody, targeting FcRn in pregnant women who are already alloimmunized. RLYB212 is not suitable for these individuals, as they already possess the alloantibodies that can cause FNAIT.
Stephen Uden, M.D., Chief Executive Officer of Rallybio, expressed enthusiasm about the partnership, stating that the combined efforts could potentially offer treatment options to pregnant women at risk of FNAIT, regardless of alloimmunization status.
Rallybio's natural history study excludes pregnant individuals who are already alloimmunized, as the investigational therapy RLYB212 is designed as a preventive measure rather than a treatment for those with established alloimmunization.
There is currently no approved therapy for the prevention or prenatal treatment of FNAIT, a rare disease that can lead to severe health outcomes for newborns, including miscarriage, stillbirth, or lifelong neurological disabilities.
Rallybio's portfolio includes other clinical programs targeting maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The company is headquartered in New Haven, Connecticut.
This news is based on a press release statement from Rallybio Corporation.
InvestingPro Insights
Rallybio Corporation's strategic partnership with Johnson & Johnson signifies a promising step forward in the biotech industry, particularly in addressing fetal and neonatal alloimmune thrombocytopenia (FNAIT).
As Rallybio gears up for a Phase 2 study of RLYB212, the financial health and market sentiment surrounding the company provide a critical backdrop for investors and stakeholders monitoring the firm's progress.
InvestingPro data reveals that Rallybio currently holds a market capitalization of $61.63 million, reflecting the company's valuation in the eyes of investors. Despite the challenges, two analysts have revised their earnings upwards for the upcoming period, indicating a potential optimism in the company's future performance.
This contrasts with the company's current P/E ratio, which stands at -0.88, suggesting that the market has not yet seen profits to justify the equity prices. Additionally, the firm's price/book ratio as of the last twelve months ending Q4 2023 is 0.58, which could imply that the stock is potentially undervalued relative to its assets.
An InvestingPro Tip worth noting is that Rallybio holds more cash than debt on its balance sheet. This is a crucial indicator of financial stability, especially for a biotech firm like Rallybio that requires significant capital for research and development. Moreover, the company's liquid assets exceed short-term obligations, providing a cushion for operational expenses and investment in its pipeline of therapies.
Still, another InvestingPro Tip indicates that the company is quickly burning through cash, which could be a concern for long-term sustainability if not managed effectively. Investors interested in a deeper analysis can explore additional InvestingPro Tips for Rallybio, including insights on the company's gross profit margins, stock price movements, and profitability forecasts.
With 11 additional tips available on InvestingPro, users can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription for a comprehensive understanding of Rallybio's financial and operational outlook.
As Rallybio continues to innovate in the field of maternal fetal health, these financial metrics and insights provide a valuable context for evaluating the company's potential and the impact of its collaboration with Johnson & Johnson.
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