At RareMoon, the rare disease community is the heart of our mission. We are driven by the often unmet needs of patients and the startups working tirelessly to develop life-changing therapies. With over a decade of expertise and an unmatched success rate in Orphan Drug Designation (ODD) submissions, we guide companies through rigorous regulatory pathways to deliver meaningful results as efficiently as possible. Our team’s personal experiences with debilitating diseases among our closest friends and family fuel our commitment to this cause. This is why RareMoon is proud to once again give back.
We are thrilled to announce a pro bono US FDA Orphan Drug Designation preparation and submission opportunity, designed to support new clients in advancing rare disease therapies. To qualify, applicants must be developing a therapy for a rare disease, supported by preclinical or clinical data. Additional criteria will be evaluated by our subject matter experts. We deeply value our ongoing partnerships with existing clients and look forward to exploring other ways to collaborate on their important work.
This marks our second pro bono ODD initiative, following the success of our first award to Siren Biotechnology for its gene therapy program for glioblastoma (Read More). That award supported Siren in advancing their innovative work, and we are eager to support another company in accelerating their development.
Does your program qualify for an ODD? We invite you to share by completing the form below. A winner will be selected and notified on June 30, 2025. Regardless of the outcome, our team will share an initial feasibility assessment and is happy to schedule a follow-up consultation to address any questions you may have.
We look forward to learning about your impactful work and wish you the best in your continued development.
