4DMT Gains Alignment With FDA On Plan To Lift Clinical Hold On Phase 1/2 INGLAXA Clinical Trial For 4D-310 For Fabry Disease Cardiomyopathy
Portfolio Pulse from Benzinga Newsdesk
4D Molecular Therapeutics (NASDAQ:FDMT) has gained alignment with the FDA on a plan to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310 for Fabry disease cardiomyopathy. The company has initiated a single non-human primate safety study evaluating intravenous 4D-310 combined with rituximab/sirolimus immunosuppressive regimen. The INGLAXA protocol has been amended to minimize the risk of atypical hemolytic uremic syndrome associated with intravenous AAV dosing. Interim clinical data from INGLAXA is expected to be presented in Q1 2024.
October 30, 2023 | 12:13 pm
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4D Molecular Therapeutics has gained FDA alignment to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310 for Fabry disease cardiomyopathy. This could potentially lead to positive outcomes for the company's clinical trials and future revenue.
The FDA alignment to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial for 4D-310 for Fabry disease cardiomyopathy is a positive development for 4D Molecular Therapeutics. This could potentially lead to the resumption of the clinical trial, which if successful, could result in future revenue for the company. The company's stock price could potentially increase in the short term due to this positive news.
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