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Report Snippet:
A major development happened in August when the company received a CRL from the FDA rejecting the approval of their drug Deramiocel based on Phase 2 trials. Then earlierthis month, the company released Phase-3 trials data for cardiomyopathy in DMD. It hit both the primary as well as the secondary endpoint.
In my opinion, post phase 3 data, probability of direct FDA approval is 60%, approval after another CRL is 30%, while rejection is 10%. Hence, I would be valuing it like a commercial company.
Revised Price target - $65
Report Snippet:
A major development happened in August when the company received a CRL from the FDA rejecting the approval of their drug Deramiocel based on Phase 2 trials. Then earlierthis month, the company released Phase-3 trials data for cardiomyopathy in DMD. It hit both the primary as well as the secondary endpoint.
In my opinion, post phase 3 data, probability of direct FDA approval is 60%, approval after another CRL is 30%, while rejection is 10%. Hence, I would be valuing it like a commercial company.
Revised Price target - $65
Himanshu Somani - Connect with me on
linkedin.com/in/himanshusomani
shmventures.substack.com
linkedin.com/in/himanshusomani
shmventures.substack.com
Disclaimer
The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.
Himanshu Somani - Connect with me on
linkedin.com/in/himanshusomani
shmventures.substack.com
linkedin.com/in/himanshusomani
shmventures.substack.com
Disclaimer
The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.