According to a recent FiercePharma article, Ascendis Pharma has received a $150M investment from Royalty Pharma. In return, Royalty Pharma will get a 9.15% royalty on Skytrofa sales in the United States in 2025. This cash will help Ascendis lower its costs and deliver medicines to patients faster. Skytrofa is the first drug of its kind and only needs to be taken once a week, unlike the daily alternatives. It made about $39M in 2022, and is on track to outpace those sales this year.
However, Ascendis encountered a setback with its second product, TransCon PTH, as the FDA raised manufacturing concerns rather than clinical issues in a complete response letter. The agency specifically pointed out problems with Ascendis' manufacturing control strategy related to dose variability. Despite this setback, the company has submitted additional information regarding its updated manufacturing control strategy and held a productive meeting with the FDA. Ascendis Pharma intends to resubmit its TransCon PTH application by October.