MeiraGTx (MGTX) said Monday that AAV2-hAQP1 received regenerative medicine advanced therapy designation from the US Food and Drug Administration.
AAV2-hAQP1 is being developed for the treatment of grade 2/3 radiation-induced xerostomia, a common side effect of head and neck cancer radiotherapy that causes dry mouth, according to the company.
The company's drug candidate also received orphan drug designation from the FDA previously and the RMAT designation will allow for frequent regulatory interactions with the agency, MeiraGTx said.
Shares of the company were up 6.1% in recent trading.
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