Core Viewpoint - Galectin Therapeutics Inc. is advancing its investigational drug belapectin for the treatment of MASH cirrhosis and portal hypertension, with recent FDA communications indicating alignment on trial design and patient population [1][2][3]. Group 1: FDA Interaction and Clinical Development - The FDA has provided written feedback on Galectin's Type C meeting request, indicating alignment on the proposed patient population for a registration trial [2]. - Galectin plans to hold a follow-up Type C meeting to finalize unresolved components of the clinical trial design and present new biomarker data [3][4]. - The company views the upcoming FDA interaction as crucial for clarifying the path forward for belapectin's Phase 3 clinical trial [4]. Group 2: Financial Position and Funding - Galectin Therapeutics has secured a new $10 million unsecured, convertible line of credit from its chairman, extending the maturity dates of existing convertible lines of credit and notes through June 30, 2027 [6]. - The company believes its cash resources, along with the new credit facilities, are sufficient to fund expected expenditures through at least March 2027 [6]. Group 3: Company Commitment and Future Outlook - The company remains committed to advancing belapectin for patients with advanced fibrotic liver disease and is actively engaging with the FDA [5][7]. - The CEO expressed confidence in belapectin's potential and gratitude for the chairman's increased financial commitment, which will support multiple strategies for the drug's advancement [7].
Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027