Ascendis Pharma A/S (NASDAQ: ASND) stock rose over 2.8% in the pre market session on November 19th, 2019 (Source: Google finance) after the company in the third quarter of FY 19 update. During the third quarter, the company continued to execute on the Vision 3×3 strategic road map, including completing the long-term clinical follow up and manufacturing of drug product PPQ batches for TransCon Growth Hormone and increasing the global reach through VISEN’s initiation of a phase 3 trial of TransCon Growth Hormone in Greater China. Moreover, during the quarter, the company had initiated the ACcomplisH Trial, which is a global, phase 2, randomized, double-blind, placebo-controlled trial made for the evaluation of the safety and efficacy of TransCon CNP, a long-acting prodrug of C-type natriuretic peptide (CNP), at escalating doses in children with achondroplasia (ACH). TransCon CNP is made to provide continuous exposure to CNP at therapeutic levels with once-weekly dosing.
The firm reported the net loss of EUR25.1 million compared to a net loss of EUR34 million during the same period in 2018. The company has ended the third quarter with cash and cash equivalents of EUR658.7 million and 47,739,647 ordinary shares outstanding.
For the third quarter, the research and development costs were EUR46.3 million compared to EUR31.5 million during the same period in 2018. Higher R&D costs during the 2019 quarter is on back of rise in personnel and infrastructure costs due to growth in headcount to support development of the product candidates, then for TransCon Growth Hormone costs were higher, mainly due to increasing costs for manufacturing of validation batches and initial costs of building inventory in anticipation of a commercial launch which for now will be recognized as R&D costs when incurred. Other R&D costs were higher, mainly due to activities within the oncology therapeutic area. The company incurred the general and administrative expenses for the third quarter of 2019 of EUR10 million compared to EUR6.8 million during the 2018 period.
ASND is on track toward filing the TransCon growth hormone BLA in the US in the first half of 2020 and the MAA in Europe in the second half of 2020. The company is also advancing the two other endocrinology rare disease programs. The company also continues to make progress with the clients through a status, global, clinical and commercial reach for our endocrinology rare disease pipeline. As the partner in China, VISEN Pharmaceuticals has initiated a phase 3 trial for TransCon Growth Hormone for pediatric growth hormone deficiency.