Reata Pharmaceuticals, Inc. Announces Third Quarter 2022 Financial Results and Provides an Update on Clinical Development Programs
In a press release and management call on November 8, 2022, Reata Pharmaceuticals reported that they have completed a Late-Cycle Meeting with the FDA. The purpose of the Late-Cycle Meeting is for the FDA to discuss any substantive issues identified and the Division’s objectives for the remainder of the review. The meeting does not address the final regulatory decision for the NDA. The FDA stated that they continue to review the analyses and data included in the recent NDA submissions. Reata reported the following from the meeting, currently there is:
- No request for additional data or analyses
- No information requests outstanding
- No current plans for an advisory committee meeting
- No issues related to risk management identified to date
Reata plans to file their Marketing Authorization Application (“MAA”) in Europe later this year.
Reata also indicated that they have advanced their commercial launch preparations in the United States and are building the infrastructure necessary to support the commercialization of omaveloxolone for the treatment of Friedreich’s ataxia, if and when they receive regulatory approval. Reata also announced the "REACH Program," a Patient Access Services Program to assist patients and HCPs in the US with obtaining access to omav, if it is approved.
Click here to read the full press release.
Click here to listen to a recording of the management call.
