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Acadia Pharma Moves Up on FDA Approval

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Acadia Pharmaceuticals received FDA approval for Nuplazid

Today, Acadia Pharmaceuticals (ACAD) is trending higher on news of the FDA’s approval of a 34 mg capsule and 10 mg tablet of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis-related hallucinations and delusions. The stock was up ~12% in pre-market trading.

Significance of new dosage regimen

With the approval of the 34 mg capsule, patients should experience a reduced pill burden from the current therapy, which requires two 17 mg pills daily. Plus, the 10 mg tablet gives access to an optimized, lower-dose drug in patients receiving strong cytochrome 3A4 inhibitors, which inhibit Nuplazid metabolism.

According to Steve Davis, president and CEO of Acadia Pharmaceuticals, “We are very pleased with the FDA approval of the NUPLAZID 34 mg capsule and 10 mg tablet, underscoring ACADIA’s continued dedication to advancing safe and effective treatment options for patients living with hallucinations and delusions associated with Parkinson’s disease psychosis.”

As per the company, the newly approved strength of Nuplazid will be available in the market from mid-August. Nuplazid sales are expected to rise after the FDA’s approval of these new capsules and tablets.

Analysts’ views on the development

Following the event, J.P. Morgan reiterated its “overweight” rating on ACAD stock with a price target of $50. J.P. Morgan analyst Cory Kasimov said, “While we see these approvals as not entirely unexpected and incremental to the overall commercial trajectory, we do believe this somewhat (but not completely) de-risks the FDA review. On that, we note that ACAD has yet to be notified of review completion. With that said, we do expect focus in the near term to remain on Nuplazid safety as well as the commercial impact, if any, to the ongoing launch in PDP.”

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