Protagonist Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 112
- Market Cap
- $2.4B
- Introduction
Protagonist Therapeutics, Inc. a clinical-stage biopharmaceutical company, which engages in discovering and developing peptide-based therapeutic drugs to address unmet medical needs. Its product pipeline includes PTG-300, PTG-200, and PN-943. The company was founded by Mark L. Smythe on August 22, 2006 and is headquartered in Newark, CA.
Ionis and Ono Forge $940 Million Deal for Sapablursen in Polycythemia Vera Treatment
• Ionis Pharmaceuticals has licensed sapablursen, an RNA-targeted medicine for polycythemia vera, to Ono Pharmaceutical in a deal worth up to $940 million including $280 million upfront.
• Sapablursen, currently in Phase 2 trials, has received FDA Fast Track and Orphan Drug designations and works by increasing hepcidin production to regulate iron homeostasis in PV patients.
• Ono will gain exclusive global rights for development and commercialization, while Ionis will complete the ongoing IMPRSSION study before transferring responsibilities.
Protagonist's Icotrokinra Shows Promising Results in Ulcerative Colitis and Psoriasis Trials
• Protagonist Therapeutics and Johnson & Johnson's oral peptide icotrokinra achieved 63.5% clinical response rate in ulcerative colitis patients at Week 12, significantly outperforming placebo in the Phase 2b ANTHEM-UC study.
• In Phase 3 trials for plaque psoriasis, icotrokinra demonstrated superior efficacy to both placebo and Bristol-Myers Squibb's Sotyktu, with 65% of patients achieving PASI 90 response by Week 24.
• The successful clinical outcomes have driven Protagonist's stock up nearly 46%, marking a financial turnaround for the company which reported its first profit of $275 million in 2024 after years of losses.
Protagonist Therapeutics Reports Strong Financial Growth with Key Clinical Milestones Ahead in Q1 2025
• Protagonist Therapeutics secured a significant $165 million milestone payment for icotrokinra in Q4 2024, strengthening their financial position with total cash reserves of $559.2 million.
• The company anticipates crucial Phase 3 VERIFY trial results for rusfertide in polycythemia vera and Phase 2b ANTHEM trial data for icotrokinra in ulcerative colitis by March 2025.
• Protagonist advanced their pipeline with PN-881, a novel oral IL-17 receptor antagonist, while maintaining strong partnerships with Takeda and Johnson & Johnson for their lead programs.
Pharma Stock Roundup: Novo Nordisk's Obesity Study Disappoints, Lilly's Zepbound Approved for Sleep Apnea
• Novo Nordisk's CagriSema obesity treatment showed a 22.7% weight loss in Phase III, falling short of the anticipated 25% reduction, impacting stock prices.
• Eli Lilly's Zepbound (tirzepatide) received FDA approval for moderate-to-severe obstructive sleep apnea (OSA), marking it as the first drug for obesity-related OSA.
• AstraZeneca and Daiichi Sankyo withdrew their EU application for Dato-DXd in non-small cell lung cancer (NSCLC) but pursue U.S. approval for EGFR-mutated NSCLC.
• Pfizer's Braftovi gained FDA approval in combination with Erbitux and mFOLFOX6 for first-line treatment of metastatic colorectal cancer with BRAF mutations.
Gilead's Trodelvy Receives FDA Breakthrough Therapy Designation for SCLC; Seladelpar Recommended for EU Approval
• The FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, based on promising results from the TROPiCS-03 study.
• Gilead will collaborate with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets, leveraging Terray's tNova platform.
• The European Medicines Agency's CHMP recommended approval of Gilead's seladelpar for primary biliary cholangitis (PBC) in combination with UDCA or as monotherapy.
Rusfertide Achieves Primary Endpoint in Phase 3 VERIFY Trial for Polycythemia Vera
• Rusfertide significantly reduced the need for phlebotomies in polycythemia vera (PV) patients, with 77% achieving clinical response compared to 33% on placebo.
• The VERIFY trial met all key secondary endpoints, including hematocrit control and improved patient-reported outcomes, demonstrating comprehensive efficacy.
• The hepcidin mimetic was well-tolerated, with no new safety concerns, suggesting a favorable risk-benefit profile for PV patients.
• Protagonist and Takeda plan to submit detailed results for presentation at upcoming medical conferences and to regulatory agencies for potential approval.
J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis
• Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis patients.
• After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score.
• Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo.
• J&J plans to submit icotrokinra for regulatory approval, positioning it as a potential oral alternative to injectable biologics for psoriasis.
Icotrokinra Shows Promising Phase 3 Results for Plaque Psoriasis Treatment
• Phase 3 trials show Icotrokinra significantly improved skin clearance in adults and adolescents with moderate to severe plaque psoriasis.
• At week 16, 64.7% of patients achieved clear or almost clear skin (IGA 0/1) with Icotrokinra, compared to 8.3% on placebo.
• Icotrokinra, a once-daily oral peptide selectively blocking the IL-23 receptor, demonstrated a safety profile consistent with earlier studies.
• Further improvements were seen at week 24, with 74.1% achieving IGA 0/1 and 64.9% achieving PASI 90, highlighting sustained efficacy.
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