Stockholm 6th of January 2025 - Alder Therapeutics was recently granted an INTERACT meeting with the US FDA
This milestone meeting provided a forum for an early dialogue on Alder’s innovative ALD01 replacement cell therapy program for retinitis pigmentosa, a progressive blinding disease characterized by the loss of light-sensing photoreceptor cells in the retina.
The meeting provided clear and positive insights and feedback on a number of topics including Alder Therapeutics' CMC, preclinical and clinical development plans for ALD01.
Kristian Tryggvason (CEO and co-founder of Alder Therapeutics) commented:
“We’re very excited about the positive and constructive feedback provided by the FDA. It is encouraging to see that the FDA has a very clear understanding of what they expect to see from replacement cell therapy developers like Alder and the feedback provided will support Alder’s immediate development plans”.
Alder Therapeutics is a virtual pre-clinical replacement cell therapy development company that is shaping the future of regenerative medicine. Founded in 2022 by seasoned cell therapy and industry experts, the company has two promising allogeneic stem cell therapy programs in the pipeline: one for degenerative eye diseases, and one for chronic heart disease. At the core of the company’s success is the AlderEdge™ platform — a novel approach to cell therapy development that keeps the commercial product in mind from the start for a de-risked route to success.
Kristian Tryggvason
CEO
Alder Therapeutics
kristian@aldertx.com
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