2023-06-28 07:56:35 ET
Reata Pharmaceuticals ( NASDAQ: RETA ) added ~8% pre-market Wednesday after announcing that the FDA approved a prior approval supplement (PAS) related to its Friedreich’s ataxia therapy, Skyclarys, which the regulator greenlighted in March.
The PAS updates the drug substance specification for Skyclarys, also known as omaveloxolone, indicated for those aged 16 years and older with FA, a rare neuromuscular disorder.
With the FDA nod for PAS, Skyclarys is now available in the U.S. for FA patients, Reata ( RETA ) said.
"We expect an effective early launch given that Reata has been in ‘action mode’ in preparation for the drug’s approval and commercialization," Cantor Fitzgerald’s Charles Duncan wrote in reaction.
With an Overweight rating and $110 per share target on Reata ( RETA ) the analyst notes that with the PAS approval, the final overhang for for Skyclarys was removed.
With its Q1 2023 results, the company said in May that the FDA is expected to take a decision on its PAS by mid-August 2023.
More on Reata
- Reata adds 21% as PTC’s Friedreich's ataxia drug fails Phase 3 trial
- Reata: FDA Approval Of SKYCLARYS Isn't Only Driver Moving Forward
For further details see:
Reata gains after FDA nod for Skyclarys marketing supplement