Mar. 24 at 2:22 PM
$ACHV interesting setup ahead of June 20 PDUFA. two positive Phase 3 trials, solid safety profile, potential first new smoking cessation therapy in 20 years. Breakthrough Therapy + Commissioner's National PV for vaping on top.
but today's earnings added real risk — going concern warning, Sopharma manufacturing dispute, FDA GMP observations on current manufacturer. manufacturing CRLs are a real thing. and even with approval, launch now pushed to H1 2027.
honestly at current prices i find
$ARVN and
$RARE more compelling PDUFA plays. ARVN trades near cash value (~
$685MM cash vs ~
$860MM mktcap) with vepdegestrant NDA under FDA review, June 5 PDUFA, Phase 3 NEJM-published data — you get the whole PROTAC platform essentially for free. RARE DTX401 PDUFA August 23 with PR strong Phase 3 data &no prior CRL.
ACHV has the narrative but the risk/reward feels less clean right now compared to those two. watching but maybe not adding here
not financial advice — just my own view. do your own research.
