Parabilis Medicines, Inc. - Common Stock (PBLS)

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 registra

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.

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

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

CAMBRIDGE, Mass., Sept. 01, 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 its Chairman, President and Chief Executive Officer Mathai Mammen, M.D., Ph.D., will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference in New York, NY at 2:35 PM ET on Wednesday, September 16, 2026.

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

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. Tendler, M.D., to its Board of Directors. Dr. Tendler previously led both clinical development and medical affairs for oncology at Johnson & Johnson. He has served as a scientific advisor to Parabilis Medicines, a role he will continue alongside his Board responsibilities. “We are delighted to welcome Craig to the Parabilis Board of Directors,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “I have known Craig for many years and know the rigor, judgment and creativity he brings. His unparalleled experience guiding innovative medicines from clinical development and global approval through subsequent product adoption and medical affairs will be tremendously valuable to Parabilis as we continue to advance zolucatetide across multiple indications and build our broader pipeline of HeliconTM therapeutics. I consider Craig to be one of the most prolific oncology drug developers in our industry. He has a strategic mind and is driven by patient needs in all that he does.” “Throughout my career, I have seen the difference that opening new therapeutic avenues can make for patients,” said Dr. Tendler. “I am pleased to join the Board of Parabilis at this pivotal time and complement its efforts to translate clinical insights into strategies that accelerate the development and approval of potentially transformational therapies such as zolucatetide.” Dr. Tendler brings more than 30 years of experience in oncology drug development and medical affairs, including two decades at Johnson & Johnson, where he held leadership roles across clinical development, medical affairs and business development and most recently served as Global Head of Late-Stage Clinical Development and Global Medical Affairs for Oncology. During his tenure at J&J, he played a key role in securing more than 30 oncology regulatory approvals across prostate cancer (ZYTIGA®, AKEEGA® and ERLEADA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®), lung cancer (RYBREVANT®) and bladder cancer (BALVERSA®), as well as 13 FDA Breakthrough Therapy designations and approvals for 15 New Molecular Entities (NMEs). He also worked closely with clinical and commercial teams to support the practical adoption of many of these practice-changing medicines through medical affairs data generation activities in collaboration with academic and community-based investigators. Dr. Tendler also played an integral role in securing major oncology business development transactions and collaborations, including J&J’s acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals and Taris Biomedical and co-development partnerships with Legend Biotech, Pharmacyclics and Genmab.

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CAMBRIDGE, Mass., June 11, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines, Inc. (Nasdaq: PBLS) (“Parabilis”), a clinical-stage biopharmaceutical company built to develop transformative medicines addressing some of the most consequential, yet historically undruggable, protein targets driving human disease, today announced the closing of its upsized initial public offering of an aggregate 38,525,000 shares of its common stock, including the full exercise by the underwriters of their overallotment option to purchase 5,025,000 additional shares, at an initial public offering price of $20.00 per share. All of the shares of common stock were offered by Parabilis. Parabilis’ common stock began trading on the Nasdaq Global Select Market on June 10, 2026 under the ticker symbol “PBLS”.