Reata Pharmaceuticals ( NASDAQ: RETA ) shares gained ~191% on Wednesday to reach the highest level since Dec. 2021 as Wall Street welcomed the FDA approval of its rare disease therapy omaveloxolone for neuromuscular disease Friedreich's ataxia.
Nearly ~11.2M Reata ( RETA ) shares changed hands, compared to the 65-day average of ~980.9K, as the stock marked the biggest ever intraday gain,
During a conference call following the approval, the company announced plans to launch omaveloxolone, the U.S.-authorized FA therapy, at $370K under the brand name, Skyclarys during May - June 2023.
"First, the price reflects the small size of the patient population," Chief Commercial Officer of Reta ( RETA ) Dawn Bir said, citing approximately 4.5K FA patients as the total addressable market for the therapy.
Bir also attributed the pricing decision to the unmet medical need and Skyclarys's novel mechanism action that required 15 years of R&D.
After the approval, multiple analysts issued positive views on Reta ( RETA ), including Cantor Fitzgerald's Charles Duncan, who raised the company's price target to $121 from $61 per share, citing a model update.
The analyst reiterated the Overweight rating on the stock, citing Skyclarys's clean safety profile and the company's plans to expand its label for those under 16.
Ahead of the FDA action date for omaveloxolone, Reta ( RETA ) shares sold off amid concerns about the retirement of FDA's neuroscience chief Billy Dunn.
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Reata adds 190% to reach two year-high after FDA nod for rare disease therapy