Ascendis Pharma submits sBLA for growth hormone deficiency therapy [Yahoo! Finance]
Ascendis Pharma A/S - American Depositary Shares (ASND)
Last ascendis pharma a/s - american depositary shares earnings: 11/18 04:01 pm
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Source: Yahoo! Finance
the US Food and Drug Administration (FDA) for TransCon hGH to treat adults with growth hormone deficiency (GHD). TransCon hGH is marketed in the US as SKYTROFA for paediatric GHD. The sBLA is supported by the results from the foresiGHt Phase III trial, which demonstrated the therapy's efficacy and safety. This study included 259 adults aged between 23 and 80 years with GHD. Participants were randomised in a 1:1:1 ratio and received either a target fixed dose of TransCon hGH, a placebo, or daily hGH. The doses were titrated based on the participants' age and oral estrogen intake, ensuring approximately equivalent hGH milligrams per week for both TransCon hGH and daily hGH. At week 38 of the trial, TransCon hGH-treated patients reported a statistically significant reduction in trunk fat and an increase in total body lean mass compared to the placebo group, achieving superiority on its primary efficacy and key secondary efficacy endpoints. Ascendis Pharma president and CEO Ja
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News
- Ascendis Pharma A/S (NASDAQ: ASND) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Ascendis Pharma A/S (NASDAQ: ASND) had its price target lowered by analysts at TD Cowen from $160.00 to $153.00. They now have a "buy" rating on the stock.MarketBeat
- Ascendis Pharma A/S (NASDAQ: ASND) had its price target lowered by analysts at Oppenheimer Holdings Inc. from $190.00 to $180.00. They now have an "outperform" rating on the stock.MarketBeat
- Ascendis Pharma A/S (NASDAQ: ASND) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $170.00 price target on the stock.MarketBeat
- Ascendis Pharma A/S (NASDAQ: ASND) had its price target raised by analysts at Stifel Nicolaus from $200.00 to $207.00. They now have a "buy" rating on the stock.MarketBeat
ASND
Earnings
- 11/14/24 - Miss
ASND
Sec Filings
- 11/19/24 - Form 144
- 11/14/24 - Form SC
- 11/14/24 - Form 6-K
- ASND's page on the SEC website