- Trial Phase
- Phase 2 (RDEB-SCC); previously Phase 3 (MDS, failed)
- Time to Market
- Unknown — the drug has failed Phase 3 in MDS and is being repositioned for RDEB-SCC. A confirmatory Phase 2 trial is being planned but requires a partner. Best case 4-7 years from a partnership deal to potential approval in this ultra-rare indication.
- Why 3/10
- Rigosertib has no hard dated binary catalyst (PDUFA, pivotal readout) scheduled in the next ~12 months. The company is actively seeking a partnership to fund a confirmatory Phase 2 trial in RDEB-SCC, but no trial start date or data readout is committed. Without a dated catalyst, impactScore is capped at 5; given rigosertib is a legacy pipeline program at a company now focused on antivirals, it scores 3.
Rigosertib is not the primary value driver at Traws Pharma — the company's antiviral pipeline (tivoxavir) and recent hantavirus/Ebola programs have been the key stock movers in 2026. Watch for a potential rigosertib partnership/licensing deal, but the stock's trajectory is being set by the antiviral clinical holds and regulatory setbacks, not this oncology program.
Price Chart
Executive Summary
Rigosertib is an oncology drug that failed two Phase 3 trials in myelodysplastic syndromes (MDS) and has been effectively deprioritized by developer Traws Pharma (formerly Onconova Therapeutics). The company has pivoted to antiviral drugs (influenza, hantavirus, Ebola) and is now actively seeking a partner to take rigosertib forward in RDEB-associated squamous cell carcinoma, an ultra-rare skin cancer. Early data in 5 patients showed an 80% response rate, but this is a very small dataset. There is no near-term binary catalyst, no regulatory submission planned, and the stock has been battered by clinical holds on its lead antiviral program — not by rigosertib news. Both HC Wainwright and Ladenburg Thalmann downgraded TRAW from Buy to Neutral in June 2026.
How It Works
Rigosertib is a synthetic small-molecule drug that disrupts cancer cell division by inhibiting polo-like kinase 1 (PLK1) and the PI3K/Akt signaling pathway — two targets that cancer cells rely on to grow and multiply. It essentially puts the brakes on several cancer-driving machinery at once, causing tumor cells to self-destruct (apoptosis). It can be given intravenously or orally.
Trial Status
Rigosertib failed two Phase 3 trials in higher-risk myelodysplastic syndromes (MDS) — ONTIME (2014) and INSPIRE (2020) — both missing overall survival endpoints. It is now being repurposed for recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-SCC), an ultra-rare skin cancer. A small Phase 1/2 investigator-sponsored study (5 evaluable patients) published in the British Journal of Dermatology in June 2025 showed an 80% overall response rate with 50% complete responses. Traws Pharma is planning a confirmatory Phase 2 trial and actively seeking a development partner.
The Two-Sided Case
Upcoming Catalysts
- Potential partnership/licensing deal for rigosertib (no timeline — company 'actively seeking' a partner)
- Possible start of a confirmatory Phase 2 trial in RDEB-SCC (contingent on finding a partner)
- Any data presentations at medical conferences could re-rate the narrative
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Traws Pharma, Inc. 424B5 TRAW ·Originating report