As of midafternoon Wednesday, shares of Reata Pharmaceuticals (NASDAQ:RETA) were up by a whopping 22.7%. That was on the back of very promising news on the regulatory front for the clinical-stage biotech.
Reata disclosed that it received a notice from the Food and Drug Administration stating that a pre-New Drug Application (NDA) meeting is the most appropriate forum to discuss the company’s omaveloxolone. This is a drug candidate that treats Friedreich’s ataxia, a genetic disease that can cause difficulty in walking and impaired speech, among other effects.
The regulator has three types of meetings for discussing investigational drugs with applicants: A, B, and C. In the FDA’s words, a Type A meeting is when “needed to help an otherwise stalled product development program proceed.” Type B covers end-of-clinical-trial-phase discussions and pre-NDA talks. Type C is a catchall for meetings not covered by the other types.
Reata had requested a Type C meeting, so the FDA’s notice could represent a big step toward potential approval for omaveloxolone. The biotech said it will follow the regulator’s suggestion to withdraw its current request for a Type C meeting, and file one for a pre-NDA meeting “as soon as practicable.”
Friedreich’s ataxia is a rare disease that has no known cure; there is also no drug approved to treat it. Omaveloxolone has performed well in clinical trials, so if approved it will be a real advance in the fight against the disorder — not to mention a boon for Reata.
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