BioArctic receives Orphan Drug Designation in the US

The Board of Directors of Flerie and the Board of Directors of Toleranzia have adopted a plan to join forces through a statutory merger between the companies in accordance with the Swedish Companies Act.

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HLX22 (AC101), an anti-HER2 monoclonal antibody, for the treatment of gastric cancer.

Xbrane Biopharma has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million.

The FDA has approved the company’s IND application to initiate the Phase I/II study Oncorella-1.

This collaboration aims to advance the discovery and development of new therapeutic solutions targeting G protein-coupled receptors (GPCRs), ion channels, transporters and other integral membrane proteins in therapeutic areas such as mental health and cardio-renal-metabolic diseases.

The company has secured a financing round of EUR 19 million, part of which was raised in Europe and part in Australia, to clinically develop its innovative immune therapy for cancer.

The two companies have announced the availability of SELARSDI injection in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.