At the recent JPMorgan conference, ACADIA Pharmaceuticals (ACAD) presented a business update highlighting several catalysts anticipated in 2020, notes John McCamant, biotech sector expert and editor of Medical Technology Stock Letter.
The first is the dementia-related psychosis (DRP) sNDA submission expected in mid-2020 following an FDA AdCom meeting expected in H1:20.
The second significant catalyst will be the major depressive disorder (MDD) Phase III CLARITY-2 US results which are expected in Q4:20 and then the Phase III CLARITY-3 EU results due in H1:21.
Negative symptom schizophrenia (NSS) is another potential expansion for Nuplazid and the Phase III ADVANCE-2 initiation is likely to start in the middle of this year.
Lastly at the JPMorgan conference, ACAD reaffirmed guidance for FY19 Nuplazid sales of $330-340 million, in line with the consensus estimate of $337.6 million.
The DRP sNDA submission is anticipated in mid-2020 following an FDA meeting planned for H1:20. Approval should include a broad label for DRP based on the consistently positive Phase III HARMONY results across various dementia subtypes.
MDD Phase III CLARITY-2 US results are expected in Q4:20, earlier than initially anticipated. The Phase III CLARITY-3 EU will be right behind with results expected in H1:21.
The NSS Phase III ADVANCE-2 pivotal trial is anticipated to initiate in mid-2020 following the positive Phase II ADVANCE results that recently read out in Q4:19. ACAD noted that 40-50% of all schizophrenia patients experience negative symptoms for a potential addressable population of another 700,000 patients.
2020 has huge potential for ACAD and Nuplazid as the DRP, MDD and NSS markets dwarf the current PDP market. The company has done a very good job of expanding Nuplazid’s clinical profile and, we believe that this has attracted the attention of Big Pharma acquirers as the pill now has multi-billion potential.
One key positive for acquirers is the drug has already been FDA approved significantly de-risking the asset. We would also reminder investors that the largest shareholder and Board member of ACAD are The Baker Brothers, with roughly a 26% stake.
