May 26 Quick Takes: Reata therapy under priority review for Friedreich’s ataxia

FDA granted priority review to omaveloxolone from Reata Pharmaceuticals Inc. (NASDAQ:RETA) to treat Friedreich’s ataxia, with a PDUFA date of Nov. 30 for the oleanane triterpenoid that activates NFE2L2 and inhibits NF-kB. After initially concluding in 2020 that a supporting analysis from the pivotal Phase II MOXIe trial did not strengthen results beyond the trial’s primary analysis, suggesting that Reata may have had to conduct a second pre-approval study of omaveloxolone, the agency later welcomed a pre-NDA meeting and accepted a submission that includes data from MOXIe’s extension study. Reata expects an advisory committee to review the NDA.

Shares of Avadel Pharmaceuticals plc (NASDAQ:AVDL) sank $2.31 (68%) to $1.07 Thursday after the company revealed that FDA “deemed inappropriate” a statement in its NDA for FT218, potentially delaying the therapy’s approval until June 2023. The biotech hopes to gain approval of the sodium salt of GHB to treat narcolepsy. The agency’s issue with the NDA centers on a statement regarding a REMS patent owned by Jazz Pharmaceuticals plc (NASDAQ:JAZZ), which markets sodium oxybate therapies Xyrem and Xywav. FDA had extended FT218’s review beyond its original PDUFA date of Oct. 25, 2021. Jazz gained 3% to $152.46...