Swedish biotech Calliditas has announced plans to file its rare disease drug Nefecon with the FDA early next year following positive results from a phase 3 clinical trial.
Swedish biotech Calliditas has raised $90 million in an upsized US IPO and private placement, valuing the rare kidney and liver disease specialist at $467 million as the craze for biotech I
European regulators have granted a fast path to market for Calliditas Therapeutics’ potential rare kidney disease drug, Nefecon, weeks after a similar decision by the FDA.
The FDA has just made it easier for Sweden’s Calliditas to develop Nefecon for a rare kidney disease, accepting a faster readout that should hasten development of the drug.