1. Cassava Sciences received a full FDA clinical hold on simufilam trial. 2. FDA requires additional pre-clinical data and protocol modifications. 3. Clinical trial for TSC-related epilepsy now delayed beyond early 2026. 4. Company reported $106.1 million cash to sustain operations until 2027. 5. SAVA shares dropped 25.26% to $2.13 following the announcement.
FAQ
Why Very Bearish?
The clinical hold on simufilam hampers progress and indicates regulatory challenges. Similar past FDA holds have resulted in significant stock declines.
How important is it?
The article highlights critical FDA interactions and a substantial price drop, indicating investor anxiety.
Why Long Term?
Delays in trial initiation and potential regulatory scrutiny will impact SAVA's trajectory for years, as seen in other biotech firms facing prolonged FDA processes.