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The FDA granted regenerative medicine advanced therapy designation to ATSN-201, a gene therapy candidate for the treatment of X-linked retinoschisis, according to a press release from Atsena Therapeutics.
The designation is given to regenerative medicine therapies “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition,” with preliminary clinical evidence potentially addressing unmet needs, according to the release. It is intended to expedite the drug