Latest news with #Nuplazid
Yahoo
07-08-2025
- Business
- Yahoo
Acadia Q2 Earnings Beat, Nuplazid & Daybue Sales Drive Revenue Growth
Acadia Pharmaceuticals ACAD reported second-quarter 2025 earnings of 16 cents per share, which beat the Zacks Consensus Estimate of 14 cents. In the year-ago quarter, the company had reported earnings of 20 cents per share. Acadia recorded total revenues of $264.6 million, which surpassed the Zacks Consensus Estimate of $260 million. ACAD's net product revenues comprise revenues generated from the sale of its two marketed products, Nuplazid (pimavanserin) and Daybue (trofinetide). Acadia's first drug, Nuplazid, is approved in the United States for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACAD's second product, Daybue, received approval in 2023 for treating Rett syndrome in adult and pediatric patients aged two years and older. The drug was launched in the United States in April 2023. Total revenues increased 9% year over year, driven by contributions from Daybue and continued growth in Nuplazid's market share. ACAD's Q2 Results in Detail Revenues from Nuplazid increased 7% year over year to $168.5 million in the second quarter of 2025, driven primarily by volume growth. Nuplazid sales beat the Zacks Consensus Estimate of $166 million as well as our model estimate of $164.8 million. Daybue recorded net product sales of $96.1 million in the reported quarter, up 14% year over year, driven by the growth in the drug's unit sales as Acadia shipped to more unique patients. Per the company, ACAD reached a new record high in the second quarter, with 987 unique patients receiving a Daybue shipment. The upward trend signals promising growth in both new patient starts and treatment persistence. The reported figure beat the Zacks Consensus Estimate of $93.7 million as well as our model estimate of $91.5 million. Year to date, shares of Acadia have rallied 29.7% compared with the industry's 0.2% growth. Image Source: Zacks Investment Research Research and development (R&D) expenses were $78 million, up 2% year over year. Selling, general and administrative (SG&A) expenses were $133.5 million, up 14% year over year. The increase can be primarily attributed to higher marketing costs to support the Nuplazid and Daybue franchises in the United States and investments for the planned expansion of the Daybue commercial team. Acadia had cash, cash equivalents and investments worth $762.0 million as of June 30, 2025, compared with $681.6 million as of March 31, 2025. ACAD Updates 2025 Financial Outlook Acadia now expects total revenues from the U.S. sales of its products to be in the range of $1.045-$1.095 billion, up from the previously guided range of $1.030-$1.095 billion. Nuplazid net product sales are now expected to be in the range of $665-$690 million in 2025, up from the previous guidance of $650-$690 million. U.S. sales of Daybue are expected to remain between $380 million and $405 million. R&D expenses in 2025 are projected to be in the range of $330-$350 million, while SG&A expenses are expected to be between $535 million and $565 million. ACAD's Key Updates 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 reported completing enrollment in the phase III COMPASS PWS study of ACP-101 for Prader-Willi Syndrome (PWS). Top-line results are expected in the fourth quarter of 2025. Subject to the study's success, ACAD plans to submit a regulatory application to the FDA, seeking the approval of ACP-101 for PWS in the first quarter of 2026. During the reported quarter, the U.S. District Court in Delaware ruled in Acadia's favor concerning the '721 formulation patent for Nuplazid. The Court upheld Acadia's position on both infringement and validity in its patent litigation against Aurobindo Pharma Limited and other abbreviated new drug application filers. The judgment issued by the Delaware Court provides patent protection for the Nuplazid 34 mg capsule formulation until 2038. In June, Acadia received a favorable ruling from the U.S. Court of Appeals for the Federal Circuit, which upheld a December 2023 decision by the U.S. District Court for the District of Delaware validating the '740 composition of matter patent for Nuplazid. The ruling, stemming from Acadia's litigation against MSN, extends patent protection for the drug's composition into 2030. These are two huge wins for Acadia, collectively protecting the company's Nuplazid sales from generic erosion in the U.S. market for the Parkinson's disease indication. ACADIA Pharmaceuticals Inc. Price, Consensus and EPS Surprise ACADIA Pharmaceuticals Inc. price-consensus-eps-surprise-chart | ACADIA Pharmaceuticals Inc. Quote ACAD's Zacks Rank & Stocks to Consider Acadia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Arvinas ARVN, CorMedix CRMD and Immunocore IMCR. While CRMD and IMCR sport a Zacks Rank #1 (Strong Buy) each at present, ARVN currently carries a Zacks Rank #2 (Buy). 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 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 47.5%. CorMedix's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%. In the past 60 days, estimates for Immunocore's 2025 loss per share have narrowed from 86 cents to 68 cents. Loss per share estimates for 2026 have narrowed from $1.34 to $1.10 during the same period. IMCR stock has increased 8.8% year to date. Immunocore's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%. In the past 60 days, estimates for Arvinas' 2025 loss per share have narrowed from $1.51 to $1.50. Loss per share estimates for 2026 have narrowed from $3.08 to $2.98 during the same period. ARVN stock has plunged 66.5% year to date. Arvinas' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CorMedix Inc (CRMD) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Arvinas, Inc. (ARVN) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
26-06-2025
- Business
- Yahoo
Acadia Pharmaceuticals price target raised to $38 from $26 at RBC Capital
RBC Capital raised the firm's price target on Acadia Pharmaceuticals (ACAD) to $38 from $26 and keeps an Outperform rating on the shares. The firm is updating its model and believes that the stock represents a solid commercial-stage story with an emerging pipeline, the analyst tells investors in a research note. RBC adds that the 'meaningful' recent Nuplazid IP win is providing Acadia with a high likelihood of cash flow sustainability and commercial tailwinds of late, suggesting some continued Nuplazid growth and Daybue stabilization prospects. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Disclaimer & DisclosureReport an Issue Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-06-2025
- Business
- Yahoo
US Appeals Court Confirms Patent Validity of Acadia's Parkinson's Medication
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is among the 13 Biotech Stocks with Huge Upside Potential. It declared that the U.S. Court of Appeals maintained the legality of its composition of matter patent for the medication Nuplazid, which treats psychosis in Parkinson's disease. A research scientist looking through a microscope in a lab, symbolizing the biopharmaceutical company's innovative approach to medical treatments. The verdict supports ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) in its legal struggle with India-based MSN Laboratories and upholds a December 2023 ruling by the U.S. District Court of Delaware. A later patent claim with the same priority date cannot be declared invalid by the court. According to CEO Catherine Owen Adams, Nuplazid's patent protection has been extended to 2030. The 34 mg capsule is also protected by a separate formulation patent that runs through 2038. The U.S. FDA authorized Nuplazid in 2016 to treat delusions and hallucinations linked to psychosis in Parkinson's disease. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)'s legal stance in a different action against Aurobindo Pharma was further strengthened by the latest decision. When taken as a whole, these results solidify the company's portfolio of intellectual property in the face of generic competition, guaranteeing prolonged market exclusivity for its flagship neurological medication. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is a biopharmaceutical firm that specializes in the creation and marketing of medications that treat uncommon diseases and disorders of the central nervous system. While we acknowledge the potential of ACAD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11-06-2025
- Business
- Yahoo
US Appeals Court Confirms Patent Validity of Acadia's Parkinson's Medication
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is among the 13 Biotech Stocks with Huge Upside Potential. It declared that the U.S. Court of Appeals maintained the legality of its composition of matter patent for the medication Nuplazid, which treats psychosis in Parkinson's disease. A research scientist looking through a microscope in a lab, symbolizing the biopharmaceutical company's innovative approach to medical treatments. The verdict supports ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) in its legal struggle with India-based MSN Laboratories and upholds a December 2023 ruling by the U.S. District Court of Delaware. A later patent claim with the same priority date cannot be declared invalid by the court. According to CEO Catherine Owen Adams, Nuplazid's patent protection has been extended to 2030. The 34 mg capsule is also protected by a separate formulation patent that runs through 2038. The U.S. FDA authorized Nuplazid in 2016 to treat delusions and hallucinations linked to psychosis in Parkinson's disease. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)'s legal stance in a different action against Aurobindo Pharma was further strengthened by the latest decision. When taken as a whole, these results solidify the company's portfolio of intellectual property in the face of generic competition, guaranteeing prolonged market exclusivity for its flagship neurological medication. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is a biopharmaceutical firm that specializes in the creation and marketing of medications that treat uncommon diseases and disorders of the central nervous system. While we acknowledge the potential of ACAD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-06-2025
- Business
- Yahoo
US appeals court confirms patent validity of Acadia's Parkinson's drug
(Reuters) -Acadia Pharmaceuticals said on Monday that the U.S. Court of Appeals has confirmed the validity of its patent for Nuplazid, its drug for hallucinations and delusions associated with Parkinson's disease. The decision supports a December 2023 ruling from the U.S. District Court of Delaware, ensuring the patent remains protected in Acadia's legal battle against India-based drugmaker MSN Laboratories. The appeals court followed a precedent that says an earlier patent claim cannot be invalidated by a later one if they share the same priority date. "We are gratified that the U.S. Federal Appeals Court has affirmed the lower court's ruling in favor of our composition of matter patent for Nuplazid, securing protection into 2030 for this patent, and beyond based on the recent favorable ruling for our formulation patent providing patent protection for Nuplazid 34 mg capsule formulation into 2038," said CEO Catherine Owen Adams. This decision comes after another favorable ruling for Acadia regarding its formulation patent for Nuplazid. The court supported Acadia's claims of infringement and validity in its legal case against Aurobindo Pharma and other companies. The U.S. FDA approved Nuplazid for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis in 2016.
