We received a letter dated January 5, 2023, notifying us that CIPLA submitted to the FDA a Paragraph IV Certification on the US ‘984 patent. These patents are listed in the FDA Orange Book for PEDMARK ® . The certifications allege these patents are invalid or will not be infringed by the manufacture, use, or sale of CIPLA’s sodium thiosulfate solution.
Partnerships Norgine: exclusive license to commercialize PEDMARQSI in Europe, Australia, New Zealand ($43M upfront; up to ~$230M milestones; tiered royalties to mid-20s); Inpharmus: distribution agreement for Turkey and GCC countries (2025)
Indications
prevention of cisplatin-induced ototoxicity in pediatric patients (localized, non-metastatic solid tumors)(Approved)
Status note Sodium thiosulfate injection; FDA-approved September 2022 (first and only FDA-approved therapy for this indication), EC June 2023, UK October 2023; commercially available in US since October 2022; Norgine launched in UK and Germany in 2025 with further EU launches expected 2026+. Lifecycle: Japan STS-J01 investigator-initiated trial positive topline December 2025; registration strategy and partnering discussions ongoing (no date stated). Investigator-initiated studies ongoing in adult/AYA populations (exploratory, not approved).
Per-asset detail extracted from the 10-Q filed 2026-08-13. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
No lead program on file for this company.
No active ClinicalTrials.gov trials matched to this company as sponsor or collaborator.
Specialist fund holders
Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.
None of the tracked specialist funds reported a position in the latest 13F snapshot.
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