Strategic Fit of ACP-101 Promises Future Revenue Growth for Acadia Pharmaceuticals: Analyst

Tuesday, Acadia Pharmaceuticals Inc ACAD announced the addition of a new Phase 3 development candidate to its rare disease portfolio, ACP-101 (intranasal carbetocin), for hyperphagia (a false and unrelenting state of starvation) in Prader-Willi syndrome.

Acadia acquired worldwide rights to develop and commercialize ACP-101 by acquiring Levo Therapeutics in June 2022.

Before Acadia's acquisition, Levo conducted a Phase 3 study evaluating two doses of ACP-101, 3.2 mg, and 9.6 mg, versus a placebo three times daily. 

Top-line results showed that ACP-101 was safe and well-tolerated and demonstrated nominally statistically significant efficacy at the 3.2 mg dose.

"We recently met with the FDA and reached alignment to further evaluate the 3.2 mg dose of ACP-101 in a pivotal Phase 3 study," said Doug Williamson, Acadia's Executive Vice President, Head of Research and Development.

Needham writes that the Phase 3 asset ACP-101 adds upside optionality for Acadia's future revenue growth and has a strong strategic fit with the company's focus on rare diseases with the recent launch of Daybue. 

The analyst also struggles to have high confidence in the POS of the upcoming Phase 3, given the lack of dose response in the previous Phase 3, although we keep an open mind based on the benefits seen with the 3.2 mg dose.

JMP Securities says ACP-101 is a logical fit for the company, with established clinical data to mitigate the development risk. It leverages Acadia's rare disease development and commercial expertise, including synergies with Daybue.

The analyst has increased the price target to $31 from $23 with a Market Outperform.

Price Action: ACAD shares are down 2.88% at $24.31 on the last check Wednesday.