Parabilis Medicines (PBLS) FDA Approvals $26.40 -0.45 (-1.68%) As of 10:39 AM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest Parabilis Medicines' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Parabilis Medicines (PBLS). Over the past two years, Parabilis Medicines has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Zolucatetide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Zolucatetide FDA Regulatory Events Zolucatetide is a drug developed by Parabilis Medicines for the following indication: key driver of a range of cancers and tumor types. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - October 14,2026Provided Update Phase 1/2Drug: ZolucatetideAnnounced Date: October 14, 2026Indication: key driver of a range of cancers and tumor types.AnnouncementParabilis Medicines announced the initiation of a dose-ranging clinical cohort evaluating zolucatetide in patients with familial adenomatous polyposis (FAP) as part of the company’s ongoing Phase 1/2 clinical trial. Zolucatetide is Parabilis’ lead investigational Helicon™ peptide and the first and only direct inhibitor of the β-catenin:TCF interaction, a key driver of a range of cancers and tumor types.Read Announcement Parabilis Medicines FDA Events - Frequently Asked Questions Has Parabilis Medicines received FDA approval? As of now, Parabilis Medicines (PBLS) has not received any FDA approvals for its therapy in the last two years. What drugs has Parabilis Medicines submitted to the FDA? In the past two years, Parabilis Medicines (PBLS) has reported FDA regulatory activity for Zolucatetide. What is the most recent FDA event for Parabilis Medicines? The most recent FDA-related event for Parabilis Medicines occurred on October 14, 2026, involving Zolucatetide. The update was categorized as "Provided Update," with the company reporting: "Parabilis Medicines announced the initiation of a dose-ranging clinical cohort evaluating zolucatetide in patients with familial adenomatous polyposis (FAP) as part of the company’s ongoing Phase 1/2 clinical trial. Zolucatetide is Parabilis’ lead investigational Helicon™ peptide and the first and only direct inhibitor of the β-catenin:TCF interaction, a key driver of a range of cancers and tumor types." What conditions do Parabilis Medicines' current drugs treat? Currently, Parabilis Medicines has one therapy (Zolucatetide) targeting the following condition: key driver of a range of cancers and tumor types.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arrowhead Pharmaceuticals FDA EventsAtara Biotherapeutics FDA EventsBioVie FDA EventsOcugen FDA EventsParabilis Medicines FDA EventsPharming Group FDA EventsQuoin Pharmaceuticals FDA EventsEntrada Therapeutics FDA EventsZai Lab FDA EventsAgomAb Therapeutics FDA EventsAlkermes FDA EventsBeam Therapeutics FDA EventsBiomea Fusion FDA EventsBioNTech FDA EventsEnanta Pharmaceuticals FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies BridgeBio Pharma FDA Events Halozyme Therapeutics FDA Events Madrigal Pharmaceuticals FDA Events BioMarin Pharmaceutical FDA Events Vaxcyte FDA Events Krystal Biotech FDA Events Protagonist Therapeutics FDA Events Kymera Therapeutics FDA Events Arrowhead Pharmaceuticals FDA Events TG Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:PBLS last updated on 10/14/2026 by MarketBeat.com Staff. 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Provided Update - October 14,2026Provided Update Phase 1/2Drug: ZolucatetideAnnounced Date: October 14, 2026Indication: key driver of a range of cancers and tumor types.AnnouncementParabilis Medicines announced the initiation of a dose-ranging clinical cohort evaluating zolucatetide in patients with familial adenomatous polyposis (FAP) as part of the company’s ongoing Phase 1/2 clinical trial. Zolucatetide is Parabilis’ lead investigational Helicon™ peptide and the first and only direct inhibitor of the β-catenin:TCF interaction, a key driver of a range of cancers and tumor types.Read Announcement
