News briefing: FDA requests new trial for Reata's Friedreich's ataxia program; J&J's Tremfya picks up expanded label in Europe
Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.
In early Wednesday morning trading, Reata stock was down roughly 8% off the news. It’s a smaller dive than when the company first said the program could be set back, though, as shares lost about a third of their value at the time.
As such, this news was not entirely unexpected but still proved disappointing to analysts.
“While the path forward for omaveloxolone in the US remains to be determined, we believe it is largely derisked by the positive results seen” in the study, SVB Leerlink’s Joseph Schwartz wrote to investors.
Baird’s Brian Skorney took a more bullish view, describing the update as merely an “incremental negative.” Skorney said he has been operating with a delay being the “base-case assumption” and that the news doesn’t affect Reata’s other program, bardoxolone for rare kidney diseases, which is expected to be filed in the first quarter of 2021.
The FDA did not rule out reconsidering omaveloxolone’s application once the new study has been completed, Reata noted.
J&J’s Tremfya picks up expanded label in Europe
Tremfya, also known as guselkumab, had previously been approved on the continent for moderate to severe plaque psoriasis. The drug is a monoclonal antibody targeting p19 in the IL-23 and inhibits its interaction with the IL-23 receptor.
Wednesday’s approval comes on the basis of two Phase III studies looking at adults who had active PsA and those who were biologic-naïve. Both studies looked at patients who had previously failed standard therapies.
Back when it first got US approval in 2017, analysts pegged peak annual sales for the drug at $1.6 billion, which would make it a top 20 drug. Through the first three quarters of 2020, Tremfya had netted J&J and Janssen $965 million worldwide.