Reata down on potential block to omaveloxolone in genetic disorder

Despite its Q2 beat, Reata Pharmaceuticals (RETA -31.7%) is down out the gate on the heels of its update on omaveloxolone for Friedreich’s Ataxia (FA), a rare genetic disease that causes difficulty walking, a loss of sensation in the arms and legs, and impaired speech.

There is a risk that the filing of a U.S. marketing application will be delayed indefinitely if the FDA requires an additional pivotal study due to the limited availability of FA patients.

In October 2019, the company announced positive results from Part 2 of the Phase 2 MOXIe study. The FDA, however, appears unconvinced that the data are sufficient to support approval.

Considering the long timeline associated with conducting another pivotal trial, the company has proposed a crossover study as a compromise. It would measure the effect of omaveloxolone in patients in the control arm of MOXIe who are receiving the med in the open-label extension.

If the agency signs off on its proposal, RETA expects to complete the crossover study as early as Q4 with an NDA to follow in Q1 2021.

If the FDA rejects the proposal or if the data are not supportive, it will evaluate whether it is feasible to conduct a second pivotal study. In other words, development may stop.

https://seekingalpha.com/news/3603396-reata-pharma-down-32-on-potential-roadblock-on-omaveloxolone-in-rare-neurodegenerative