Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAL101, its lead clinical candidate currently being evaluated in patients with idiopathic pulmonary fibrosis (IPF).
Calluna Pharma Successfully Completes Phase 1 Clinical Study of CAL101, a First-in-Class Therapeutic for Fibrotic and Fibro-Inflammatory Indications
Calluna Pharma AS (Calluna), a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced the completion of Phase 1 clinical study for CAL101, Calluna’s lead product candidate. The study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile for the mAb.
Calluna Pharma appoints Mark Gaffney as Chief Executive Officer and Mark Altmeyer as Independent Chair of the Board
Calluna Pharma AS (Calluna), a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced the appointments of Mark Gaffney as Chief Executive Officer and Mark Altmeyer as Chair of the Board. Alongside these appointments, John Montana, who has been acting as the Company's interim CEO, will return to his role as an Operating Partner at Forbion.
Calluna Pharma Launches and Announces EUR 75 Million Series A Financing to Develop Novel Therapies for Inflammatory and Fibrotic Diseases
Oxitope Pharma (Oxitope) and Arxx Therapeutics (Arxx), companies with a shared goal of leveraging the innate immune system to discover and develop disease modulating therapies, today announced their merger to form Calluna Pharma Inc. (Calluna). Calluna has raised EUR 75 million in a series A financing and is backed by Oxitope and Arxx’s existing lead investors, Forbion, Sarsia, p53, and Investinor. The new company will combine expertise in the field of innate immunity, based on damage-associated molecular patterns (DAMPs), with a pipeline of selective antibodies that target inflammatory and fibrotic indications, including several first-in-class clinical candidates.
