Partnerships Biotest AG: exclusive license to market and sell ASCENIV in Europe and certain Northern Africa/Middle East countries (2012 agreement; in-kind services and cash milestones paid; adjustable royalty on territory revenues for 20 years from first commercial sale)
Status note FDA approved April 2019. Label expanded to pediatric patients ages 2+ in May 2026. Yield-enhancement PAS approved April 2025. Filing notes potential future evaluation in RSV-infected immune-compromised patients, not yet a stated trial.
Status note FDA approved May 2019 for PI in adults and pediatric patients 2+. Yield-enhancement PAS approved April 2025; FY2026 is first full year of yield-enhanced production.
S. pneumoniae infection in vaccine-naive and immune-compromised patients(Preclinical)
Catalysts
— fiscal year 2026
Status note Pilot-scale batch produced 2024; animal studies ongoing. Commissioner National Priority Voucher (CNPV) application submitted September 2025, if accepted could accelerate FDA review by two fiscal quarters or more.
Per-asset detail extracted from the 10-Q filed 2026-08-05. 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.
No specialist-fund holders in 13F data for this company.
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