Volatile Pharma stock to watch: Ascendis Pharma A/S (NASDAQ: ASND)

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Ascendis Pharma A/S (NASDAQ: ASND) stock fell over 1.1% in the pre-market  on April 2nd, 2020 (Source: Google finance) after the company has reported for 2019 a net loss of EUR218 million or EUR 4.69 per basic and diluted share compared to a net loss of EUR130.1 million or EUR3.17 per basic and diluted share during 2018. The company had ended 2019 with cash and cash equivalents at EUR598.1 million. Research and development costs for 2019 had increased to EUR191.6 million compared to EUR140.3 million during 2018.

Moreover, during the quarter, the company had completed enrollment of 59 subjects in the PaTH Forward Trial, which is a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult HP subjects.  The company had expanded the trial in November 2019 to show the enrollment of subjects affected by the NATPARA recall. The goal of PaTH Forward is the identification of a starting dose (15, 18, or 21 mg per day) for a pivotal phase 3 trial, which will establish a titration regimen for complete withdrawal of standard of care, and evaluate TransCon PTH control of serum and urinary calcium.

With regard to TransCon Growth Hormone, the company is on track with its plans to submit the U.S. BLA filing in the second quarter and the MAA filing in the fourth quarter, both for pediatric growth hormone deficiency. The company has executed a robust Phase 3 program, is now evaluating the potential of TransCon Growth Hormone in both treatment-naive and treatment experienced subjects. TransCon Growth Hormone is the only long-acting growth hormone in clinical development that release somatropin with the identical immuno-assay sequence and size to daily or DOCSIS growth hormone. The company has already have completed manufacturing of PPQ batches and has completed the development of the auto-injector, is on a track for commercial availability. Further, for TransCon PTH, the company is developing a true PTH replacement therapy designed to sustain physiologic levels of PTH 24 hours a day, seven days a week with once-daily administration. In 2020, for TransCon PTH, the company has planned to report topline Phase 2 PaTH Forward data in mid-April, then six months open-label extension data in the third quarter and start a global Phase 3 clinical trial for adult hypoparathyroidism in the fourth quarter. For TransCon CNP, through the strategic investment, the company is supporting VISEN Pharmaceuticals as they work to initiate a Phase 2 clinical trial for achondroplasia, ACcomplisH China in the fourth quarter and lastly, in the oncology therapeutic area, the company intends to submit the first IND or equivalent by the end of the year.

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