Acadia Pharmaceuticals (ACAD) volition inquire the Food and Drug Administration to o.k. a once-rejected psychosis drug, but ACAD banal plunged connected Tuesday.
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The FDA antecedently rejected Acadia's Nuplazid arsenic a attraction for dementia-related psychosis. Still, aft a gathering with the FDA, Acadia says it believes the bureau could o.k. Nuplazid for Alzheimer's patients suffering from hallucinations and delusions.
Leerink expert Marc Goodman called the determination "aggressive." The FDA said the champion way guardant would beryllium to tally different survey successful Alzheimer's patients. Instead, Acadia is submitting a caller investigation of existing results from a survey called Harmony.
"The willingness of the FDA to reconsider and reappraisal the caller subgroup analyses presented by Acadia without an further survey is encouraging," helium said successful a study to clients. "However, fixed the information that absorption confirmed its unwillingness to tally an further survey successful (Alzheimer's illness psychosis), it is evident that resubmission is its past strategy, which we presumption arsenic aggressive."
Investors were uneasy astir the move. On today's banal market, ACAD banal tumbled 20.8% to adjacent astatine adjacent 21.45.
ACAD Stock Faces New Catalysts
Nuplazid is already approved to dainty hallucinations and delusions associated with Parkinson's disease. But the institution had been hoping to grow that to each dementias. In April, the FDA rejected that bid.
The resubmission "punctuates an eventful twelvemonth of regulatory surprise," RBC Capital Markets expert Brian Abrahams said successful a study to clients. "Now, importantly, (it) sets up a program-defining 2022 arsenic a first-quarter refile and a imaginable year-end FDA determination participate the fold."
Abrahams reiterated his outperform standing connected ACAD stock, but raised his terms people by $2 to 34.
"Today's improvement present makes for a catalyst-rich year," helium said. Acadia should soon cognize whether the FDA volition necessitate an advisory committee gathering to see Nuplazid successful Alzheimer's patients. And the FDA could yet o.k. the cause wrong six months.
Shares Run Up To 6-Month High
Mizuho Securities expert Vamil Divan besides accrued his terms people connected ACAD banal to 33 from 26. But helium kept his neutral standing connected shares. He sees conscionable a 20% probability that the FDA approves Nuplazid for Alzheimer's patients suffering hallucinations and delusions.
"We stay skeptical that a resubmission based connected caller analyses from existing (test) information volition beryllium capable to get approval," helium said successful a note.
ACAD banal ran up to a six-month precocious done Monday's close, according to MarketSmith.com. Prior to Tuesday's driblet shares had gained for the past six consecutive trading days.
Follow Allison Gatlin connected Twitter astatine @IBD_AGatlin.
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