Aug. 20 at 6:42 PM
RBC Capital reiterated
$AXSM Outperform-
$189 and said, FDA Flexibility On Mixed Data In Neuro-psych Gives Us Confidence AXS-05 Is Approvable In Alzheimer's Agitation.
$OTSKY HLUBF HLBBF
$ALKS $CNTA $BTAI ACAD
With investors focused on the regulatory path for AXS-05 in Alzheimer' Agitation, we took the opportunity to review why we think the drug is approvable.
We note the FDA demonstrates clear flexibility for missed endpoints in neuro-psychiatric drugs (with
additional flexibility for drugs that have expedited designations), a clear acceptability for randomized withdrawal trials to support data packages, and ultimately, we believe that AXS-05's clears the bar for efficacy while demonstrating substantial safety improvements over standard of care that make an approval likely.
Taken together, we would be buyers as we see substantial upside opportunity give a
$1B+ U.S. opportunity, potential for an approval in 1H26, and believe shares can ultimately be up as much as 45% from current levels.
