Ascendis Pharma A/S (NASDAQ: ASND) Reports Q2 2021 Net Loss of €134 Million

News Alert: Citius Pharmaceuticals Receives FDA Approval For LYMPHIR™ (Denileukin Diftitox-Cxdl) Immunotherapy For The Treatment Of Adults With Relapsed Or Refractory Cutaneous T-Cell Lymphoma. Click to Read More.

Ascendis Pharma A/S (NASDAQ: ASND) has announced its Q2 2021 financial results for the period ending June 30, 2021. 

Ascendis reported a net loss of €134.4 million 

In Q2 2021, the company posted a net loss of €134.4 million or €2.5 per basic and diluted share compared to a net loss of €94.9 million or €1.97 per basic and diluted share a year ago. Revenue was €1 million compared to €1.4 a year ago. The decrease was attributed to the low license revenue amount recognized in Q2 2021. Still, it was partially offset by the high clinical services and supplies sale to VISEN  and revenue from services offered to another partner. The company ended the quarter with €641.3 million in cash, equivalents, and marketable securities. 

Ascendis CEO Jan Mikkelsen said, “We are actively preparing for the U.S. commercial launch of SKYTROFA for the treatment of children with GHD, which is now the first FDA-approved once-weekly treatment for pediatric GHD. SKTROFA is also the first FDA-approved product utilizing our innovative TransCon technology. Our pivotal heiGHt Trial demonstrated that once-weekly TransCon hGH increased annualized height velocity in treatment-naïve subjects at 52 weeks compared to a daily growth hormone with comparable safety and tolerability. We see this approval as the first step in creating a market leading product and building a fully integrated global biopharmaceutical company guided by our values of patients, science, and passion.”

SKYTROFA received FDA approval in the US

The company has made significant progress with TransConhGH (lonapegsomatropin). TransConhGH now has FDA approval in the US marketed as SKYTROFA. Additionally, Ascendis is preparing for commercial launch in pediatric GHD patients’ treatment in the US. Also, the company a decision from the European Commission regarding its Marketing Authorization Application for pediatric GHD patients treatment in Q4 2021. 

Enrolment is currently ongoing in the foresigGHt Trial in adult GHD patients and the riGHt Trial in Japan in pediatric GHD patients.