Jan. 12 at 4:17 PM
$XBI $IBB $BBC
Shares of Atara Therapeutics
$ATRA were cut in half after the FDA issued another Complete Response Letter for Ebvallo (tabelecleucel) for treating EBV+ PTLD (Epstein-Barr virus positive post-transplant lymphoproliferative disease).
While this is a very small company (market cap nearing
$60M), the fallout appears much greater as the second CRL represents a COMPLETE reversal of the FDA's prior position (that the single arm ALLELE trial was adequate to support BLA filing).
This is even more confounding because the first CRL was due only to CMC (manufacturing) and NO concerns were raised regarding trial design or data. This time around, the FDA is claiming that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.
Again, with multiple positive tailwinds like M&A for biotech, it's discouraging to see FDA Commissioner @DrMakaryFDA and team suck confidence out of the sector and drive investors away
