Rallybio is focused on therapies for rare maternal–fetal diseases, principally RLYB212, a human monoclonal anti‑HPA‑1a antibody designed to prevent alloimmunization that causes FNAIT. The company is running a natural history study to support a future registrational study and plans a phase 2 dose‑confirmation trial for RLYB212 in the second half of this year. Rallybio describes RLYB212 as the only known clinical‑stage therapy designed to prevent FNAIT in pregnant individuals who haven’t alloimmunized. Its other lead program, RLYB116, is a C5 inhibitor the company believes could treat diseases involving complement dysregulation. Rallybio noted there are currently no approved therapies specifically preventing or prenatally treating FNAIT. The company recently reduced headcount and refocused on two phase‑2‑ready programs to extend cash runway; it entered 2024 with $109.9 million in cash, cash equivalents and marketable securities. Rallybio pursues an agnostic, disease-agnostic approach to develop therapies for rare diseases, focusing on small molecules and proteins including antibodies. Its lead asset, RLYB-211, is a hyperimmune globulin acquired from a small Norwegian startup to treat fetal and neonatal alloimmune thrombocytopenia (FNAIT) via antibody-mediated immune suppression. FNAIT currently has no approved treatment and can cause miscarriage, neonatal death, or neurological disability from fetal brain bleeding. The company raised $145 million in a Series B to advance RLYB-211 into a Phase 1/2 study in the second half of this year and to support its broader pipeline. Its pipeline also includes RLYB-212 for a rare blood disease and three preclinical protein therapeutics targeting immune-inflammatory diseases; Rallybio expects to move RLYB-212 and one preclinical program into the clinic next year. Rallybio sources assets worldwide through partnerships and acquisitions and has a discovery deal with Exscientia signed last July. The founders have said the company will not work in oncology or infectious disease and will continue to focus on modalities it believes can move the needle in rare diseases. Rallybio is a biotechnology company established to identify and accelerate the development of transformative therapies for patients with severe and rare disorders. The company focuses on developing drug candidates including antibodies, small molecules and engineered proteins against mechanisms with strong biological rationale. Rallybio plans to identify and advance therapeutic candidates this year. It was co-founded in January 2018 by Martin Mackay, PhD, Stephen Uden, MD, and Jeffrey Fryer, CPA, all industry veterans with extensive experience in drug discovery, development, and finance. The company is based in Farmington, Connecticut at the University of Connecticut's Technology Incubation Program. Rallybio secured $37.0 million in Series A financing to support its early discovery and development efforts.

Total raised

$189M

Funding rounds

3

Latest round

Equity

Latest activity

Apr 2024