Highlights/Summary of DRRX Conference call:
FDA granted Breakthrough Therapy Designation for larsucosterol (DUR-928) in Alcohol-Associated Hepatitis
Productive Type B meeting with FDA in July 2024 to discuss Phase 3 trial design
Plans to initiate Phase 3 trial in 2024 with topline results expected in 2H 2026
Potential to be the first FDA-approved treatment for Alcohol-Associated Hepatitis
Phase 2b AHFIRM trial data presented at EASL Congress 2024
FDA Fast Track Designation for lead drug DUR-928
My opinion about the future for DRRX:
They will need approximately $50M to get them to the finish line with DUR-928.
They either have to enter into a partnership with a Big Pharma Company or sell shares (this choice will dilute current shareholders equity).
They may have to sell some assets or possibly take out on more debt/loan.
They may also decide to move forward with a combination of the above options.
Looking forward in my opinion there is a strong probability that DRRX becomes a target for acquisition by Big Parma. I would not be surprised if there is a tender offer made to purchase the company after we find our the parameters of the Phase 3 study.
FDA granted Breakthrough Therapy Designation for larsucosterol (DUR-928) in Alcohol-Associated Hepatitis
Productive Type B meeting with FDA in July 2024 to discuss Phase 3 trial design
Plans to initiate Phase 3 trial in 2024 with topline results expected in 2H 2026
Potential to be the first FDA-approved treatment for Alcohol-Associated Hepatitis
Phase 2b AHFIRM trial data presented at EASL Congress 2024
FDA Fast Track Designation for lead drug DUR-928
My opinion about the future for DRRX:
They will need approximately $50M to get them to the finish line with DUR-928.
They either have to enter into a partnership with a Big Pharma Company or sell shares (this choice will dilute current shareholders equity).
They may have to sell some assets or possibly take out on more debt/loan.
They may also decide to move forward with a combination of the above options.
Looking forward in my opinion there is a strong probability that DRRX becomes a target for acquisition by Big Parma. I would not be surprised if there is a tender offer made to purchase the company after we find our the parameters of the Phase 3 study.
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