- The European Commission (EC) granted orphan medicinal product designation to Sangamo Therapeutics' ( NASDAQ: SGMO ) CAR-Treg cell therapy TX200 for treatment in solid organ transplantation.
- "Our goal with TX200 is to create a transformative therapy that reduces the risk of organ rejection, while reducing the patient burden from chronic immunosuppressive therapy," said Rob Schott, head of development for Sangamo.
- The EC decision followed a positive opinion from a panel of the European Medicines Agency.
- In EU the orphan drug status is given to therapies aimed at treating or preventing a serious or life-threatening disease which affects not more than five in 10K people in the EU. The designation has benefits, including 10 years of market exclusivity for the product, if approved.
- SGMO +2.10% to $4.85 premarket July 21
For further details see:
Sangamo's TX200 gets orphan drug tag in EU for use in organ transplant