Basilea secures $30 million BARDA grant to advance phase‑3 trials of its novel antifungal fosmanogepix
Executive summary: Basilea received USD 30 million from BARDA to fund the phase‑3 clinical development of its antifungal candidate fosmanogepix. The award supports a potentially first‑in‑class antifungal addressing a serious unmet need, which could boost Basilea’s revenue prospects and strengthen the pipeline of medical countermeasures.
Who is involved: Basilea Pharmaceutica (Switzerland), the U.S. Biomedical Advanced Research and Development Authority (BARDA), and BARDA’s contracting officers.
Likely next: Basilea will initiate or continue phase‑3 trials, with interim data expected in 2027 and a possible NDA submission in 2028 if results are favorable.
Basilea Pharmaceutica announced that it has received a USD 30 million award from the U.S. Biomedical Advanced Research and Development Authority (BARDA) under an existing agreement. The funds are earmarked for the phase‑3 development of fosmanogepix, a new broad‑spectrum antifungal agent targeting invasive fungal infections. This financing de‑risks a late‑stage asset in Basilea’s pipeline and underscores continued U.S. government investment in medical countermeasures against antimicrobial threats.
Timeline
- — Basilea erhält im Rahmen ihrer BARDA-Vereinbarung USD 30 Mio. für die Phase-3-Entwicklung des neuen Antipilzmittels Fosmanogepix (GlobeNewswire)
Analysis — what this means
Likely next events
- Phase‑3 trial initiation expected Q4 2026
- Interim efficacy read‑out projected mid‑2027
- Potential NDA submission 2028
Sectors affected
- Pharmaceuticals
- Antifungal therapeutics
- Biodefense
Regulatory implications
- FDA may grant Fast Track or Breakthrough Therapy designation based on BARDA support
- BARDA milestone payments trigger additional reporting and compliance obligations
- EMA will likely require post‑marketing surveillance for resistance development
Historical parallels
- BARDA funding for a ciprofloxacin analog in 2015
- NIH grant for a novel antifungal azole in 2018
Key entities
Sources
- Basilea erhält im Rahmen ihrer BARDA-Vereinbarung USD 30 Mio. für die Phase-3-Entwicklung des neuen Antipilzmittels Fosmanogepix — GlobeNewswire