Keros to Start Rinvatercept DMD Trial in Q1 2026, Plans ALS Regulatory Talks
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Takeda Pharmaceutical Company is a Japanese multinational pharmaceutical company headquartered in Tokyo. Founded in 1781, it is among the largest pharmaceutical companies globally and is listed in both Tokyo and New York.
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Insilico Medicine named ISM9528 as its 31st AI-driven preclinical pain candidate, published a target discovery study for a rare sinonasal cancer, and advanced partnerships with MSK and Takeda. The company is also presenting oncology programs at AACR 2026.
AI drug discovery is moving from hype to proof in 2026, with multi-billion-dollar partnerships, new joint initiatives, and major investments accelerating AI-native biotech pipelines and data-driven deals.
Abivax aligned with FDA on obefazimod NDA strategy for ulcerative colitis, targeting filing by end‑2026. Phase 3 ABTECT data at ECCO 2026 showed early symptom relief and positive DSMB safety review. Leadership appointments support potential commercialization.
U.S. biotech IPOs have returned 55% on average this year, crushing the broader IPO market. Nvidia exited Recursion as ARK Invest bought shares, while Revolution Medicines gained 132% on strong pancreatic cancer data.
Takeda reported positive ENTYVIO pediatric data, secured FDA Priority Review for oveporexton, and expanded AI drug discovery. Shares trade at ¥5,609; analyst fair value is about ¥5,263.
Novo Nordisk partners with OpenAI to speed drug discovery, with pilots by 2026. AI is moving beyond hype into pharma R&D, reflected in major collaborations and new FDA guidance.
The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.
Takeda Pharmaceutical Company has announced updates on two ongoing neuroscience clinical trials: a Phase 2 study of TAK-360 for narcolepsy and a Phase 3 study of vortioxetine for major depressive disorder in Japanese teens. Both trials are randomized, triple-blind, and currently recruiting patients.
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07765602 |
A Study of Rusfertide in Adults With Polycythemia Vera in China |
NOT_YET_RECRUITING | PHASE2 |
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A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis |
NOT_YET_RECRUITING | PHASE3 |
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A Study of Rusfertide in Japanese Adults With Polycythemia Vera |
RECRUITING | PHASE2 |
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A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia |
RECRUITING | PHASE2/PHASE3 |
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A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) |
RECRUITING | PHASE2 |
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RECRUITING | |
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NOT_YET_RECRUITING | |
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NOT_YET_RECRUITING | PHASE2 |
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ACTIVE_NOT_RECRUITING |