Calico Life Sciences LLC, a biotechnology company focused on ageing and age-related diseases, founded by Alphabet Inc (NASDAQ:GOOG) and Arthur D. Levinson, announced on Wednesday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for ABBV-CLS-628, an investigational therapy for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The product is an anti-PAPP-A monoclonal antibody that was developed by Calico in collaboration with AbbVie Inc (NYSE:ABBV).
ABBV-CLS-628 was recently granted Fast Track Designation by the FDA and is currently in a Phase 2 clinical trial assessing its safety and efficacy in patients with ADPKD.
Arthur D Levinson, PhD, Calico CEO, said: "We are pleased that ABBV-CLS-628 has received both Fast Track and Orphan Drug designations, underscoring the urgent unmet need facing the ADPKD community. People living with this disease face a high risk of rapid disease progression and we will continue to advance this programme with the goal of improving the treatment trajectory for patients."
AVEO Oncology signs development and option agreement with HiberCell
Tabelecleucel's BLA transferred from Atara Biotherapeutics to Pierre Fabre Laboratories
UCB's KYGEVVI receives FDA approval for TK2d treatment
Camurus launches Oczyesa in Germany for patients with acromegaly
Servier's VORANIGO (vorasidenib) receives Prix Galien USA Award
Bavarian Nordic secures new EU contract for up to 8 million smallpox and mpox vaccine doses
GenSight Biologics secures FDA authorisation for expanded access to GS010/LUMEVOQ in the US
Ascletis Pharma Inc selects ASC36 as clinical development candidate
Zoetis announces EU approval for Portela to relieve osteoarthritis pain in cats
Samsung Bioepis to assume European commercialisation of BYOOVIZ (ranibizumab) from January 2026
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval