Reata gets a new lease of life

The approval decision on Reata’s omaveloxolone had looked like a coin flip, and some took as a bad omen Monday’s departure of the FDA’s neuroscience chief, Billy Dunn, a champion of controversial drugs with scant clinical backing. So yesterday’s news of a green light in Friedreich’s ataxia, with a surprisingly broad label and benign toxicity warnings, was greeted with a 180% hike in Reata’s share price this morning. The product, branded Skyclarys, could bring in over $1bn in the US at peak, Stifel analysts estimate, based on a list price of $370,000 per year. A lack of other approved therapies should work in Reata’s favour, and the group also has $388m in the bank plus a priority review voucher that could be worth around $100m. Still, Reata might choose to raise money while it can, as the track record of small company solo launches is poor. Stifel says the FDA nod could also revive interest in Nrf2 activation – the antioxidant mechanism behind omaveloxolone, Reata’s other late-stage project bardoxolone, and certain MS drugs like Tecfidera. There is not much activity here, although Astrazeneca recently licensed an Nrf2 activator programme from C4X.  

Nrf2 activators in development
Product Company Indication Note
Omaveloxolone Reata  Friedreich’s ataxia FDA approved Feb 2023
Phase 3
Bardoxolone methyl Reata/Kyowa Kirin Kidney disease CRL Feb 2022 in Alport syndrome; Ayame Japanese trial in diabetic CKD, data due H1 2023; Falcon in ADPKD completes Apr 2025
Phase 1/2
AJ201 Annji Pharmaceutical Spinal & bulbar muscular atrophy NCT05517603 completes Sep 2023
Phase 1
HPP971 Anteris Bio (via Vtv Therapeutics) Renal diseases Two ph1 studies completed when Anteris licensed project in 2020
SCO-116 Kuria Therapeutics (via Scohia Pharma) Eye and skin diseases Topical formulation
HPP3033 Vtv Therapeutics Undisclosed  
M102 Aclipse Therapeutics Amyotrophic lateral sclerosis  
ADPKD=autosomal dominant polycystic kidney disease; Source: Evaluate Pharma &

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