Galectin Therapeutics received a written response from the FDA following a Type C meeting request regarding belapectin's development program.
The FDA's feedback indicated alignment on the patient population and an agreement on the use of a centralized endoscopy review.
The Company plans to hold a follow-up Type C meeting to finalize components of the next clinical trial design and present recent biomarker data.
FDA Alignment
FDA aligned with Galectin Therapeutics on the proposed patient population and endoscopy review approach.
Follow-Up Meeting
A follow-up Type C meeting is planned to finalize remaining trial design components and present new biomarker data.
Financial Support
Secured a new $10 million line of credit from Chairman Uihlein, extending maturity dates for existing credit facilities.
- The FDA's response represents progress towards clarity on belapectin's clinical development.
- The planned Type C meeting aims to integrate key opinion leaders' insights and refine the clinical development strategy.
- Galectin Therapeutics' financial strengthening with the $10 million credit line enhances its capacity for strategic exploration.
Galectin Therapeutics shows commitment to advancing belapectin for liver disease patients, expressing confidence in the program's potential and gratitude for the additional financial support from Chairman Uihlein.