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Spyre Drug Meets Midstage Target in Ulcerative Colitis, Stock Rallies

The data position Spyre to run larger placebo-controlled trials backed by a $300 million stock sale.

Overview

  • Spyre Therapeutics, which reported Phase 2 results Monday, saw its shares jump roughly 30% to a multi‑year high.
  • SPY001 met the study’s main goal by cutting tissue‑level inflammation at 12 weeks, with 40% of patients in clinical remission and 51% showing endoscopic improvement in this colon inflammation disease.
  • Safety in the 12‑week induction period included six treatment‑emergent events, one serious event labeled unrelated to the drug, and back pain as the most common side effect in two patients.
  • Recruitment for SKYLINE Part A has closed and Part B enrollment is open across monotherapy and combo cohorts, with more readouts expected in mid‑2026 and Q3 2026 and Part B induction data planned for 2027.
  • Following Monday’s results, the company launched a $300 million share offering with a $45 million overallotment option, as it positions SPY001 against Takeda’s Entyvio and touts cross‑trial comparisons with J&J’s VEGA.