Spyre Therapeutics (SYRE) is having a rough Wednesday. The biotech's stock dropped more than 12% after the company revealed that its experimental rheumatoid arthritis (RA) drug, SPY072, didn't quite clear the bar the company had set for itself.
The data came from the RA arm of the Phase 2 SKYWAY trial. On the surface, things looked decent: the drug hit statistical significance on the primary endpoint and showed a clean safety profile. But Spyre had set an internal benchmark to decide whether to push SPY072 forward in RA, and the results just didn't measure up.
What the Data Showed
Here's the breakdown from the Tuesday release. Both doses of SPY072 hit their target drug concentrations. The therapy also provided complete, durable suppression of free TL1A through 12 weeks, which signals that the drug was fully engaging its target.
The low dose showed a statistically significant improvement over placebo on the primary endpoint, which measured the change from baseline in DAS28-CRP at Week 12. The high dose, meanwhile, produced nominally significant improvements on the secondary ACR20 endpoint, and the low dose did the same on the exploratory ACR50 endpoint.
Interestingly, the results were similar whether patients were new to advanced therapies or had prior exposure to them.
Safety and Next Steps
On safety, SPY072 was well tolerated. The adverse event rate in the treatment arm was 27%, compared to 36% in the placebo group, which is a good sign for the drug's profile.
But despite these positives, Spyre has decided not to prioritize SPY072 in RA. The company is now looking ahead to other indications. It plans to report topline data for SPY072 in psoriatic arthritis and axial spondyloarthritis by the fourth quarter of 2026. And for the combination of SPY072 with IL17-A/F in hidradenitis suppurativa, data is expected in late 2027 or early 2028.
Investors didn't love the news. Shares were down 12.33% at $94.12 at the time of publication, according to market data.
It's a reminder that in biotech, hitting statistical significance isn't always enough. Sometimes the internal calculus about where to invest resources matters just as much as the p-values.
