Weekly Growth Hormone Phase 3 Results Imminent

We eagerly await Ascendis's (ASND) imminent phase 3 top-line results for its weekly growth hormone therapeutic candidate, TransCon GH. This therapy would be a significant improvement in quality of life for children with growth hormone deficiency because there are reports that adherence to the current daily growth hormone products is low, and this results in suboptimal growth. Furthermore, it would be a welcome relief for these children, to have weekly instead of daily injections.

We believe that TransCon GH is likely to meet its primary endpoint of non-inferiority over control daily hGH, in height velocity over 52 weeks, based on its strong Phase 2 results over a 26 week period. However, at Amp we are mainly playing a bullish option spread across this read-out to protect our downside, because with about a $3 billion market cap for ASND, and TransCon GH its most advanced asset, it seems to us that there is more downside than upside at this point. However, a positive readout should read through positively on at least some of ASND's other products, which should help lift the stock even at the current level, especially considering the greater than $1 billion market for growth hormone products currently.

Some of the risks for this readout include that the phase 2 trial was only 26 weeks in duration, not 52 weeks like the current phase 3. Furthermore, the patient numbers in the phase 2 (52) and phase 3 (161) are relatively small, leaving more room for error. Finally, there was a BMI change in the phase 2 trial, with the control reducing BMI and TransCon GH holding BMI steady, and we are not certain how regulators or the market will view this difference if it repeats in the phase 3.

The company has announced that at the latest they will report data at the ENDO 2019 meeting on March 24. Therefore, we know that the data will come on March 24 at the latest. However, the CEO clarified at the recent JP Morgan conference that they are not waiting for ENDO to readout data if the numbers have been crunched sooner.

If you want to see all our Amp Core trades in real-time and see our Amp Core positions, become an Amp Core subscriber today at https://www.ampbioresearch.com/premium-plan.

#AmpFree #ASND


*Disclaimer: Information provided on bpiq.com and in any of our reports, products and services are for information only and are not investment advice. Please consult with an investment adviser and do your own diligence before making any investment decisions or taking any action.  By accessing this site, you agree to our Terms of Use and Privacy Policy that can be accessed here. Big Movers™ is a trademark of Amp Biotech Research, LLC

©2021 by Biopharm IQ. Website by Awaken Studio.