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ACAD Stock Down 10% Following Phase III Hyperphagia Study Failure
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Key Takeaways
Acadia's ACP-101 failed to show benefit in phase III PWS study, ending its development.
Nuplazid and Daybue sales rose double digits in H1 2025, fueling ACAD's revenue growth.
SLNO stock jumped as Vykat XR gains ground with ACAD exiting the PWS hyperphagia market.
Shares of Acadia Pharmaceuticals (ACAD - Free Report) lost 9.9% on Wednesday after the company announced a disappointing update from a late-stage study of its investigational candidate, intranasal carbetocin (ACP-101), in patients with hyperphagia in Prader-Willi syndrome (PWS).
Acadia Pharmaceuticals’ 12-week, phase III COMPASS PWS study was evaluating the efficacy and safety of a thrice-daily, 3.2 mg dose of ACP-101 in 175 enrolled children and adults aged five to 30 years with PWS. The study’s primary endpoint was the change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).
Per the data readout, ACP-101 failed to achieve a statistically significant benefit over placebo on the primary endpoint of the COMPASS PWS study and did not separate from placebo on any of its secondary endpoints. Its safety and tolerability were in line with prior studies, with a low incidence of adverse events.
Following the dismal results, Acadia Pharmaceuticals has decided not to investigate ACP-101 any further.
Year to date, shares of Acadia have gained 15.8% compared with the industry’s 3.6% growth.
Image Source: Zacks Investment Research
ACAD’s Marketed Portfolio Expected to Drive Growth
While the setback is disappointing, Acadia Pharmaceuticals remains positioned for long-term growth, underpinned by its two approved products, Nuplazid (pimavanserin) and Daybue (trofinetide), which are expected to generate more than $1 billion in net sales by 2025.
Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. The drug enjoys patent protection in the United States until 2038, which gives it a long runway for revenue generation by protecting against generic erosion. In the first half of 2025, Nuplazid recorded $328.2 million in sales, up 14% year over year, driven primarily by volume growth.
Acadia Pharmaceuticals’ other marketed drug, Daybue, is FDA-approved for treating Rett syndrome in adult and pediatric patients aged two years and older. Daybue sales generate incremental revenues for ACAD. In the first half of 2025, Daybue recorded $180.7 million in sales, up 13% year over year, driven by the growth in the drug’s unit sales as the company shipped to more unique patients. The upward trend signals promising growth in both new patient starts and treatment persistence.
ACAD’s Key Pipeline Programs
Besides the performance of its marketed portfolio of drugs, Acadia Pharmaceuticals remains focused on the development of its remaining pipeline candidate to reduce dependence on Nuplazid for revenue generation.
A regulatory filing for trofinetide to treat Rett syndrome in adults and pediatric patients aged two years and above is currently under review in the EU. An approval in the EU is expected in the first quarter of 2026.
Acadia Pharmaceuticals is developing another investigational candidate, ACP-204, as a potential treatment for Alzheimer’s disease psychosis (ADP). It anticipates completing enrollment in the phase II RADIANT study of ACP-204 for ADP in the first quarter of 2026. Top-line data is expected in mid-2026. Furthermore, ACAD is also gearing up to initiate a separate mid-stage study of ACP-204 for a second indication (Lewy Body Dementia with Psychosis) soon.
Acadia Pharmaceuticals, in partnership with Saniona, is also gearing up to initiate a mid-stage study of yet another investigational candidate, ACP-711, for treating essential tremor in 2026.
The company is also gearing up to initiate a mid-stage study of ACP-211 for the treatment of major depressive disorder and a first-in-human study for ACP-271 in healthy volunteers, both in the fourth quarter of 2025.
ACAD’s Setback Strengthens SLNO’s Lead in the PWS Market
Soleno Therapeutics’ (SLNO - Free Report) lead product, Vykat XR (diazoxide choline) extended-release tablets, formerly known as DCCR, received FDA approval in March 2025 for treating hyperphagia in adults and pediatric patients four years of age and older with PWS. Consequently, the drug was launched in April 2025 in the United States. In the second quarter of 2025, SLNO recognized $32.7 million from the sale of VYKAT XR. A similar filing is also currently under review in the EU.
Soleno Therapeutics’ shares gained 13.5% on Wednesday and another 4.7% in the after-market hours after Acadia Pharmaceuticals’ late-stage failure cleared a key competitor from the PWS market. With ACAD discontinuing development of ACP-101, Soleno Therapeutics’ recently approved Vykat XR now holds a stronger competitive position as the only FDA-approved treatment for hyperphagia in PWS. The shift in market dynamics likely reinforced investor confidence in Vykat XR’s commercial potential, driving SLNO stock higher.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 97 cents to $1.24 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.65 to $2.09. Year to date, shares of CRMD have surged 38.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 82.4% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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ACAD Stock Down 10% Following Phase III Hyperphagia Study Failure
Key Takeaways
Shares of Acadia Pharmaceuticals (ACAD - Free Report) lost 9.9% on Wednesday after the company announced a disappointing update from a late-stage study of its investigational candidate, intranasal carbetocin (ACP-101), in patients with hyperphagia in Prader-Willi syndrome (PWS).
Acadia Pharmaceuticals’ 12-week, phase III COMPASS PWS study was evaluating the efficacy and safety of a thrice-daily, 3.2 mg dose of ACP-101 in 175 enrolled children and adults aged five to 30 years with PWS. The study’s primary endpoint was the change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).
Per the data readout, ACP-101 failed to achieve a statistically significant benefit over placebo on the primary endpoint of the COMPASS PWS study and did not separate from placebo on any of its secondary endpoints. Its safety and tolerability were in line with prior studies, with a low incidence of adverse events.
Following the dismal results, Acadia Pharmaceuticals has decided not to investigate ACP-101 any further.
Year to date, shares of Acadia have gained 15.8% compared with the industry’s 3.6% growth.
Image Source: Zacks Investment Research
ACAD’s Marketed Portfolio Expected to Drive Growth
While the setback is disappointing, Acadia Pharmaceuticals remains positioned for long-term growth, underpinned by its two approved products, Nuplazid (pimavanserin) and Daybue (trofinetide), which are expected to generate more than $1 billion in net sales by 2025.
Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. The drug enjoys patent protection in the United States until 2038, which gives it a long runway for revenue generation by protecting against generic erosion. In the first half of 2025, Nuplazid recorded $328.2 million in sales, up 14% year over year, driven primarily by volume growth.
Acadia Pharmaceuticals’ other marketed drug, Daybue, is FDA-approved for treating Rett syndrome in adult and pediatric patients aged two years and older. Daybue sales generate incremental revenues for ACAD. In the first half of 2025, Daybue recorded $180.7 million in sales, up 13% year over year, driven by the growth in the drug’s unit sales as the company shipped to more unique patients. The upward trend signals promising growth in both new patient starts and treatment persistence.
ACAD’s Key Pipeline Programs
Besides the performance of its marketed portfolio of drugs, Acadia Pharmaceuticals remains focused on the development of its remaining pipeline candidate to reduce dependence on Nuplazid for revenue generation.
A regulatory filing for trofinetide to treat Rett syndrome in adults and pediatric patients aged two years and above is currently under review in the EU. An approval in the EU is expected in the first quarter of 2026.
Acadia Pharmaceuticals is developing another investigational candidate, ACP-204, as a potential treatment for Alzheimer’s disease psychosis (ADP). It anticipates completing enrollment in the phase II RADIANT study of ACP-204 for ADP in the first quarter of 2026. Top-line data is expected in mid-2026. Furthermore, ACAD is also gearing up to initiate a separate mid-stage study of ACP-204 for a second indication (Lewy Body Dementia with Psychosis) soon.
Acadia Pharmaceuticals, in partnership with Saniona, is also gearing up to initiate a mid-stage study of yet another investigational candidate, ACP-711, for treating essential tremor in 2026.
The company is also gearing up to initiate a mid-stage study of ACP-211 for the treatment of major depressive disorder and a first-in-human study for ACP-271 in healthy volunteers, both in the fourth quarter of 2025.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
ACAD’s Setback Strengthens SLNO’s Lead in the PWS Market
Soleno Therapeutics’ (SLNO - Free Report) lead product, Vykat XR (diazoxide choline) extended-release tablets, formerly known as DCCR, received FDA approval in March 2025 for treating hyperphagia in adults and pediatric patients four years of age and older with PWS. Consequently, the drug was launched in April 2025 in the United States. In the second quarter of 2025, SLNO recognized $32.7 million from the sale of VYKAT XR. A similar filing is also currently under review in the EU.
Soleno Therapeutics’ shares gained 13.5% on Wednesday and another 4.7% in the after-market hours after Acadia Pharmaceuticals’ late-stage failure cleared a key competitor from the PWS market. With ACAD discontinuing development of ACP-101, Soleno Therapeutics’ recently approved Vykat XR now holds a stronger competitive position as the only FDA-approved treatment for hyperphagia in PWS. The shift in market dynamics likely reinforced investor confidence in Vykat XR’s commercial potential, driving SLNO stock higher.
ACAD's Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) and Kiniksa Pharmaceuticals (KNSA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 97 cents to $1.24 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.65 to $2.09. Year to date, shares of CRMD have surged 38.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 82.4% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.