Parabilis Medicines Inc.

6 days ago · seekingalpha.com

Zolucatetide gives PBLS potential in desmoid tumors, but it also has other Wnt-driven indications that could grow its TAM over time. PBLS's PEDESTAL trial is now a clearer R&D path, as long as early responses are corroborated in that Phase 3 study for tumor control. Management's runway projection also suggests they have flexibility and should be able to reach pivotal milestones with Zolucatetide.

7 days ago · seekingalpha.com

Parabilis Medicines, Inc. (PBLS) Discusses Updated Zolucatetide Data in Desmoid Tumors and Phase III Path Transcript

9 days ago · marketbeat.com

Parabilis Medicines NASDAQ: PBLS presented updated interim phase I/II data for investigational beta-catenin/TCF inhibitor zolucatetide in desmoid tumors at the European Society for Medical Oncology Congress in Madrid, reporting tumor responses, disease control and an FDA-aligned plan for a registrational phase III study.

9 days ago · globenewswire.com

CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced updated safety and efficacy data for zolucatetide, the first and only direct inhibitor of the β-catenin:TCF interaction, in patients with desmoid tumors. The data were presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain. The updated results, based on a June 22, 2026, data cutoff, include data from both the dose escalation and dose optimization portions of the ongoing Phase 1/2 trial and reinforce the strong efficacy and favorable safety and tolerability profile observed with zolucatetide. Among response-evaluable patients who began treatment at a starting dose of ≥450 mg, zolucatetide demonstrated an objective response rate (ORR) of 72.2% (13/18) in a 32-week landmark analysis. A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients who received a starting dose of ≥450 mg, with no disease progression. Data from a three-arm randomized dose optimization trial supported selection of a 450 mg weekly induction regimen administered for four cycles, followed by 300 mg every two weeks for long-term maintenance. Following productive end-of-Phase 2 discussions, Parabilis has reached alignment with the U.S. Food and Drug Administration (FDA) on the selected dose and regimen, on the use of a placebo-controlled study design, and on progression-free survival (PFS) as the primary endpoint for registrational development. Parabilis plans to initiate the randomized, double-blind PEDESTAL Phase 3 trial (Phase 3 Evaluation of DESmoid Tumor Activity with zoLucatetide) in the first half of 2027, with topline results anticipated in 2029. “Desmoid tumors are chronic and life-altering for patients, often affecting people at a young age, and patients need treatments that can deliver rapid, deep and durable tumor responses with a tolerability profile suited for long-term treatment,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “We designed zolucatetide to directly inhibit β-catenin:TCF, a historically undruggable target at the heart of the biology driving these tumors. The depth and consistency of responses we are seeing, together with the favorable safety and tolerability profile observed to date, reinforce our conviction that zolucatetide has the potential to deliver a truly differentiated medicine and meaningfully expand the number of patients who can benefit from treatment. We are very pleased with the clarity of the FDA's feedback on our registrational development strategy, and with our Phase 3 regimen selected, we are moving with urgency to bring this medicine to patients.” Updated Phase 1/2 Results As of the June 22, 2026, data cutoff, 76 patients with desmoid tumors had been enrolled and treated across all dose levels in the dose escalation and dose optimization portions of the trial. Median age was 37 years (range 19–80), and 69.7% of patients were female. The population included both patients who had previously been treated with and failed gamma-secretase inhibitors (GSIs) and patients naive to GSIs.

13 days ago · seekingalpha.com

Parabilis Medicines, Inc. is rated a speculative Buy due to its innovative peptide platform and strong rare-disease oncology pipeline. Lead asset zolucatetide (zolu) shows robust early efficacy in desmoid tumors and craniopharyngioma, with favorable safety and FDA Orphan/Fast Track designations. PBLS benefits from a $125M upfront/Regeneron partnership, $1.1B cash, and a projected cash runway into 2030, minimizing near-term dilution risk.

14 days ago · globenewswire.com

Oral presentation will include updated data from the ongoing Phase 1/2 trial, with dose optimization arm designed to inform dose and regimen selection for Phase 3 registrational trial in desmoid tumors Company to host webcast on Saturday, October 24, 2026, at 6 p.m. CEST / 12 p.m.

19 days ago · globenewswire.com

New dose-ranging cohort in FAP builds on compelling early clinical evidence observed with zolucatetide in patients with FAP and concomitant desmoid tumors

2 months ago · globenewswire.com

CAMBRIDGE, Mass., Aug. 25, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced the appointment of Craig L.

3 months ago · seekingalpha.com

Parabilis Medicines (PBLS) leverages rare, genetically simple tumors to validate its Helicon platform, aiming for broader oncology applications. PBLS holds $1.1 billion in cash, providing a runway into 2030 to support clinical trials, platform expansion, and reduce financing risk. Early zolucatetide data in desmoid tumors show 100% tumor reduction and 74% objective response, with a favorable safety profile versus competitors.

3 months ago · globenewswire.com

Advanced zolucatetide across multiple Wnt/β-catenin-driven diseases, including progress toward planned Phase 3 registrational trial in desmoid tumors