ReNeuron's ReN001 on clinical hold by FDA

22 January 2007

Guildford, UK-based stem-cell specialist ReNeuron's recently-filed Investigational New Drug application to commence a Phase I clinical study for its ReN001 stem cell stroke therapy has been placed on hold by US regulators.

The firm says it expects a telephone conference call with the US Food and Drug Administration to take place later this month, following which it will make a further announcement. On the day of the news, January 10, shares in the UK firm fell 18.4% to 36.5 pence.

Industry observers see the outcome of the FDA's decision as being a pivotal one for the future of the company. However, ReNeuron is confident that its IND will be cleared. California, USA-based Stem Cells Inc had a similar approval last year.

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