Parabilis Medicines (Nasdaq: PBLS) reported updated Phase 1/2 zolucatetide results showing a 72.2% objective response rate in desmoid tumors at 32 weeks.
At the June 22, 2026 cutoff, tumor shrinkage meeting response criteria occurred in 13 of 18 patients evaluable at 32 weeks who started at ≥450 mg. Disease control was 100% across 46 response-evaluable patients starting at those doses, with no progression. Median treatment duration in the 48-patient starting-dose cohort was 4.7 months. Treatment-related adverse events were predominantly low-grade, and no patients discontinued because of them.
Parabilis reached FDA alignment on the selected regimen, a placebo-controlled design and progression-free survival as the primary endpoint. The company plans to start the PEDESTAL Phase 3 trial in the first half of 2027, with topline results anticipated in 2029.
Parabilis Medicines (Nasdaq: PBLS) will present updated zolucatetide data in patients with desmoid tumors at ESMO Congress on October 24, 2026. The presentation covers the ongoing Phase 1/2 trial, using a June 22, 2026, data cutoff, and includes both dose escalation and dose optimization results. The desmoid tumor-specific dose optimization cohort is designed to inform dose and schedule selection for a planned registrational Phase 3 trial.
Mrinal Gounder of Memorial Sloan Kettering Cancer Center will present during the sarcoma session, scheduled for 14:45–16:15 CEST in Madrid. Parabilis will host an investor webcast that day at 18:00 CEST / 12:00 p.m. EDT, with a replay available afterward. Zolucatetide has FDA Fast Track and Orphan Drug designations for treating desmoid tumors.
Parabilis Medicines (Nasdaq: PBLS) initiated a dose-ranging cohort evaluating zolucatetide in familial adenomatous polyposis within its ongoing Phase 1/2 trial. Familial adenomatous polyposis (FAP) causes precancerous polyps. The cohort will evaluate the investigational drug alone in adults with a documented APC mutation, prior colon removal and measurable duodenal polyp burden.
Early findings in two patients with FAP and concurrent desmoid tumors showed reductions in duodenal polyp burden: one moved from Spigelman Stage IV to a near-normal duodenum, and the other from Stage II to Stage I. These stages measure disease severity. Parabilis described safety and tolerability as favorable to date and intends to use the dose-ranging study to define a dose and schedule for registrational development. It expects additional data from patients with FAP and concurrent desmoid tumors in the first quarter of 2027.
Parabilis Medicines (Nasdaq: PBLS) announced that its Chairman, President and CEO, 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. The session is scheduled for 2:35 PM ET on Wednesday, September 16, 2026, with a live audio webcast available via the Investors section of the Parabilis website.
Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company, has appointed Craig L. Tendler, M.D. to its Board of Directors, while he continues as a scientific advisor. Dr. Tendler previously led late-stage clinical development and global medical affairs for oncology at Johnson & Johnson.
According to Parabilis Medicines, Dr. Tendler brings more than 30 years of oncology drug development experience, including involvement in over 30 oncology regulatory approvals, 13 FDA Breakthrough Therapy designations and 15 New Molecular Entities. His expertise is expected to support advancement of zolucatetide and the company’s Helicon therapeutics pipeline.
Parabilis Medicines (Nasdaq: PBLS) reported second quarter 2026 results highlighted by a strategic collaboration with Regeneron and a completed upsized IPO. The Regeneron deal brought $125 million in upfront consideration and equity, with potential for up to approximately $2.2 billion in future milestone payments plus tiered royalties.
Parabilis raised $770.5 million in its IPO and ended June 30, 2026 with $1.1 billion in cash, cash equivalents and marketable securities, which is expected to fund operations into 2030. The company advanced lead Helicon™ candidate zolucatetide toward a planned Phase 3 trial in desmoid tumors and additional Wnt/β‑catenin-driven indications.
Quarterly R&D expenses were $39.4 million and G&A expenses were $11.7 million, leading to a net loss of $52.5 million, higher than the prior-year period primarily due to increased investment in clinical and preclinical programs and public-company infrastructure.
Parabilis Medicines (Nasdaq: PBLS) closed its upsized IPO of 38,525,000 common shares at $20.00 per share, including full exercise of the underwriters’ option. Shares started trading on June 10, 2026.
The company also closed a concurrent $75 million private placement to Regeneron and reported over $1.2 billion raised in 2026, with all preferred stock and a $50 million SAFE converting into common stock.
Parabilis Medicines (Nasdaq: PBLS) priced an upsized IPO of 33,500,000 shares at $20.00 per share, targeting $670 million in gross proceeds. Underwriters hold a 30-day option for 5,025,000 additional shares.
Trading on the Nasdaq Global Select Market is expected to start June 10, 2026. Parabilis also agreed to a concurrent private placement of 4,166,666 shares at $18.00 per share to Regeneron, for about $75 million in additional proceeds. Both offerings are expected to close around June 11, 2026, subject to customary conditions.