Ascendis Pharma A/S (NASDAQ: ASND) stock surged 74% on March 4th, 2019 (Source: Google finance) and continued its bullish momentum even on March 5th, 2019. Investors celebrated to positive results from a Phase 3 clinical trial, heiGHt, evaluating once-weekly TransCon Growth Hormone in children with pediatric growth hormone deficiency (GHD). Top-line data for the fliGHt Trial, evaluating TransCon hGH in subjects who switch from daily hGH, are expected in the second quarter. The company is also evaluating its technology for use in hypoparathyroidism and achondroplasia. Overall, Ascendis offers balanced clinical pipeline with fairly de-risked programs, potential best-in-class assets, an emerging new therapeutics vertical and plenty of optionality within the TransCon technology platform
Trial data showed that Ascendis’ product not only met the main goal of non-inferiority in annualized height velocity (a measure of speed of growth) at 52 weeks, but actually proved superior to daily hGH. These results could constitute a home run, considering various analysts were expecting just the non-inferiority benchmark to be met.
In the primary analysis of the intent-to-treat population, TransCon hGH showed a significantly greater annualized height velocity of 11.2 cm/year compared to 10.3 cm/year for the daily hGH — the treatment difference amounted to 0.86 cm/year, hitting a p-value of 0.0088. The experimental treatment began to surpass the comparator at a statistically significant rate from week 26 onward.
The company, which has partnered with Roche’s Genentech and Sanofi to evaluate its technology for ophthalmology and diabetes drugs respectively, has planned to submit a marketing application for its pediatric GHD product in the first half of 2020.
On the other hand, ASND has commenced an underwritten public offering of $400,000,000 of American Depositary Shares (ADSs), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. Further, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $60,000,000 of ADSs at the public offering price, less the underwriting commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Credit Suisse Securities (USA) LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering.