- The FDA designates Vical's (VICL) VL-2397 for Fast Track review for the treatment of invasive aspergillosis, an infection caused by inhaling the ubiquitous Aspergillus fungus. It is inconsequential in people with a normally functioning immune system, but can be dangerous in those with weakened immunity such as those undergoing hematopoietic stem cell transplantation, chemotherapy for leukemia or with AIDS.
- VL-2397, based on an isolate from a leaf litter fungus Acremonium species collected in Malaysia, was initially developed by strategic partner Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY). A Phase 1 study was recently initiated.
- The FDA designated it a Qualified Infectious Disease Product in August 2015 and an Orphan Drug in January of this year.
- Shares are up 16% premarket on increased volume.
Vical's antifungal candidate VL-2397 Fast Track'd for invasive aspergillosis; shares up 16% premarket
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