Mar. 16 at 2:12 PM
Raymond James on
$COGT said, Remain Strong Buy rated on COGT shares but note that with today's news that FDA accepted the bezuclastinib NDA (assigning a December 30 PDUFA date), the Agency has applied a standard review timeline to the file.
$SNY NVS OPHLY GSK
$CLDX
Raymond James added—Recall in October, FDA granted fractional BTD status (around smoldering SM and Ayvakit failures), which could have applied to the entire file, precipitating a late 3Q26 approval. With this decision, it appears BTD has been thrown out entirely (as it relates to approval timing). While it's heartening that FDA has identified no review issues and does not plan an AdCom, this delay does necessitate a downward revenue estimate on our part. We now model revenue of
$11.9M and
$325.2M, down from
$23.5M and
$393.4M for 2026 and 2027 respectively. In that these changes have no impact on our valuation year (2030), no change to price target of
$60.
