Zolucatetide Hits 72% Response Rate in Desmoid Tumors; FDA Aligns on Phase 3
PBLS is trading near its 52-week low of $22.66 (9.4% above the low) on elevated volume (2.2× avg).
Summary
Parabilis reported updated Phase 1/2 data for zolucatetide in desmoid tumors: a 72.2% objective response rate (13/18) at the 32-week landmark among patients starting at 450 mg or higher, and a 100% disease control rate across all 46 response-evaluable patients with no disease progression. Safety held up — mostly low-grade fatigue, alopecia and nausea, no discontinuations from treatment-related events, and no ovarian or high-grade GI/skin toxicity of the kind seen with GSIs. The bigger news is regulatory: after end-of-Phase 2 talks, FDA agreed on the 450 mg weekly induction then 300 mg every two weeks maintenance regimen, a placebo-controlled design, and progression-free survival as the primary endpoint. That clears the path for the PEDESTAL Phase 3 trial, which the company plans to start in the first half of 2027 with topline results expected in 2029. This follows the September 15 8-K that flagged the ESMO presentation, and it lands after the September 30 departure of Chief Medical Officer Fawzi Benzaghou — the program now has a locked registrational plan. An investor webcast is set for today at 12:00 p.m. EDT.
At the time of this announcement, PBLS was trading at $24.79 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3B. The 52-week trading range was $22.66 to $42.49. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.