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News.com.au
3 days ago
- Business
- News.com.au
Precision Points: When it comes to biotechs' messaging, a lingering KISS goes a long way
In Precision Points, Precision Funds Management executive directors Dermot Woods and Andy Clayton draw on insights from two decades on the front lines of equity markets to share their expertise with Stockhead readers. Today, Dermot Woods outlines the Perth based fund's approach to investing in the biotech space, which has parallels with its more familiar ground of the resources sector. As with its more familiar bailiwick of resources, the Precision Funds Management deploys the KISS acronym when investing in the biotech sector. Keep It Simple Stupid. 'The information has to be presented simply enough so that we semi understand it,' Precision executive director Dermot Woods says. 'It helps if can pronounce the name of a disease, or it has an action we can remember.' Woods deploys plenty of rock-kicking analogies to describe the entity's nascent interest in the biotech sector. For a start, the risk and reward parameters are strikingly similar. As with each new 'Olympic Dam-style' copper play, the chances are that the latest in-vogue drug program won't be the next Neuren Pharmaceuticals (ASX:NEU). (Neuren and its partner Acadia famously commercialised the Rett syndrome drug Daybue and the achievement is a rare exemplar of ultimate achievement). But who says investors can't have fun along the way? Have a crack Along the convoluted drug development path, it's a case of getting that risk-reward equation down pat. 'Investing in West African gold stocks is risky, but everyone knows they are risky, so the risk is priced in,' Woods says. In contrast, the biotech sector is still emerging from its post-pandemic nuclear winter that descended in late 2022. Despite notable capital raisings such as Clarity Pharmaceuticals' (ASX:CU6) $200 million whip-'round, local biotechs still are starved of capital. The upside? There's plenty of 'mispriced risk' and now is the time to 'have a crack'. More than a punt As with an iron ore explorer that chanced on lithium, Precision tentatively embraced biotech for the wrong reason. 'Like most fund managers, we had a 'zero biotech' rule for about 20 years,' he says. 'We then thought the aggregation of big data would mean that drug discoveries became quicker. 'It hasn't happened yet – but it will.' (Big data aggregation refers to collecting, combining, and summarising large labs of data into more manageable and useful formats). In the mining sector, Precision likes to see a certified resource, 'rather than punting on a piece of ground'. Precision's life sciences ethos is similar: avoid the whimsical preclinical and phase I stuff in favour of the mid-to-late pointy end. If that means writing a bigger cheque, then so be it. To date, Precision has weighed in on four ASX drug developers. The biggest, Dimerix (ASX:DXB), accounts for 4% of the fund's circa $100 million of assets. Stroke drug developer Argenica Therapeutics (ASX:AGN) comprises around 1%. Dimerix goes from 'really cheap to cheap' Precision's centrepiece biotech exposure is Dimerix, which is in phase III with its drug candidate for the kidney disease focal segmental glomerulosclerosis. The fund initially took part in the company's $20 million placement in March 2024 at 30 cents a share, after its successful interim readout. After that, Dimerix inked four global partnership deals that raked in $65 million, with up to $1.4 billion in potential milestones. Woods says Dimerix's funding position substantially derisks the company. Dimerix won't need money until the 'moment of truth': the outcome of the phase III study. Woods admits the fund could have got in cheaper, with Dimerix stock trading at a paltry six cents two years ago. He says it's a case of a stock going from 'really cheap' to cheap – with significantly less risk. Argenica was a stroke of luck The Perth-based Argenica is testing its stroke drug candidate in a local phase II trial. Having enrolled 92 patients across eight hospitals, investors should expect a data readout in early September. Ultimately, Argenica eyes a phase III trial, but the US Food & Drug Administration has asked for more safety data before it can approve the study. Given the company needs to wait for its phase II trial anyway, time is on its side. Woods says the fund weighed into Argenica three years ago, at about 40% below current levels. He says the fund was drawn to Argenica partly because of CEO Dr Liz Dallimore's 'clear vision' on the company's strategy. 'If this trial , we can buy a decent return for a very decent price," Woods says. Not PYC-ing out on a punt Despite being mining focused, Perth-based drug maker PYC Therapeutics (ASX:PYC) once was Precision's biggest holding, before the fund flipped the stock at a profit. By combining existing ribonucleic acid (RNA) drug design with its proprietary delivery platform, PYC is developing precision therapies for patients with genetic diseases that have no treatment options. PYC's lead program covers the rare eye disease retinitis pigmentosa. It is also targeting autosomal dominant optic atrophy, Phelan-McDermid syndrome and autosomal dominant polycystic kidney disease. The company's once-muddled story is gaining traction, with the stock more than doubling over the last years and pushing its market valuation over $700 million. 'They have done a really good job,' Woods says. 'But for us it's probably a bit too early stage.' Precision also took a profitable punt on a fourth non-WA drug developer, which Woods declines to name. KISS and take up Woods' overriding message to biotech management is to go for the big KISS – and enjoy the investor passion. He says KISS is especially relevant when presenting to fund managers who might look at thousands of stocks. Beyond the dense Powerpoints, Precision seeks an unequivocal answer to a precise question. It's not number 42 and the meaning of the universe, but 'are they asking for more money?'
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
News.com.au
08-05-2025
- Health
- News.com.au
Health Check: Neuren says more patients are staying the course as US Daybue sales lift
Neuren says the number of patients discontinuing its Rett syndrome drug has fallen by two-thirds over the last year LTR Pharma launches a secondary program for swallowing disorders Telix targets throat – and other - cancers Neuren Pharmaceuticals' (ASX:NEU) global marketing partner Acadia has reported strong March quarter sales of the duo's treatment Daybue in the US, for the rare neurological disorder Rett syndrome. More heartening is a drop-off in patient discontinuation rates – a sensitive topic given the drug's known side effects (diarrhoea, vomiting, possible weight loss). A rare genetic disorder evident mainly in girls, Rett syndrome affects brain development, resulting in slower development and often a shorter lifespan. The Nasdaq-listed Acadia disclosed net sales for the quarter of US$84.6 million ($130 million), 11% higher than a year previously. Sales were 15% lower than the December quarter, owing to seasonal variations and a small cut in the per-bottle price, as determined by the US Medicare system. Acadia has the US rights to Daybue, on which Neuren generates royalty income. Neuren pocketed royalties of $13.5 million, up 17%. Acadia has stuck with its calendar 2025 sales guidance of US$380-405 million, implying $62-67 million of royalty income for Neuren. Acadia says a record 954 patients received Daybue, with discontinuations down 35% on the December quarter and 66% year on year. Put another way, more than 50% of patients have continued the therapy at 12 months, while 65% of 'active patients' have been on the drug for 12 months or longer. Neuren says there's still plenty of untapped potential, given two-thirds of the 5500 to 5800 diagnosed Rett patients are yet to try the drug. Meanwhile, Neuren expects European approval in the March 2026 quarter, with pending distribution agreements to sell in certain Latin America, Middle East and Asia Pacific geographies. Neuren was due to present at Macquarie's corporate jamboree today. The developer of a nasally delivered spray treatment for erectile dysfunction, LTR Pharma (ASX:LTP) has also turned its mind to a secondary program. LTR has signed a development agreement to develop Oroflow, a spray for oesophageal motility disorders (OMD) – a group of conditions that cause impaired swallowing (dysphagia). The compact is with Strategic Drug Solutions of the US. As well as not being able to down solids and liquids, OMD patients suffer regurgitation, chest pain and sometimes weight loss. Substandard current treatments include dilation, surgery, or Botox injections. Oroflow aims to deliver relief in 10 minutes. 'There is a clear need for effective, non-invasive treatment options that can provide rapid relief for patients with swallowing difficulties,' executive chairman Lee Rodne says. The company values the OMD market globally at US$4.49 billion, with the US accounting for US$1.94 billion. The condition affects about 10.8 in every 100,000 people, but for unexplained reasons the incidence is higher in Australia (16.9). We blame all the flies. Telix's side program could be FAP-ulous Nuclear medicine house Telix Pharmaceuticals (ASX:TLX) also reports promising results from an acquired secondary program – with a throaty theme as well. The program pertains to the fibroblast activation protein – FAP – as expressed by several cancers. As reported in the American Thyroid Association's official journal, unsurprisingly monikered Thyroid, FAP showed 'encouraging efficacy' against aggressive thyroid cancer in a 73-patient study. The heavily pre-treated patients showed median progression-free survival of 29 months, which meant their tumours didn't get bigger. Overall survival was 32 months, with a 'manageable' safety profile. Telix last year acquired the FAP program, dubbed TLX-400, from its inventors at Germany's Johannes-Gutenberg University. The terms were €10 million ($17.6 million) cash and €132 million of milestones if the program progresses as either a diagnostic tool or a therapy. Telix chief medical Dr David Cade says the results compare positively to the current treatment – tyrosine kinase inhibitor drugs – which can have nasty side effects. The company is eyeing multiple solid tumour types, including bladder cancer. Telix has two approved prostate cancer diagnostics on market and is angling for US Food & Drug Administration (FDA) consent for a kidney cancer diagnostic. A Roxsta moment for Memphasys Last week we mentioned Memphasys (ASX:MEM) and its successful trial of its sperm separation device for assisted reproduction purposes, Felix. There's another leg to the Memphasys tale: its Roxsta device that measures antioxidant levels in human and animal biological samples. Memphasys today said various pilot studies had shown Roxsta's ability to perform mass testing in various contexts, including oxidative stress in cattle and antioxidant levels in professional footballers. In the case of the latter, the technology 'demonstrated the capacity to process 96 samples in less than an hour, delivering highly accurate data in a fraction of the time compared to traditional methods.' Currently, commercially available methods can take up to 16 hours to deliver a single result, while Roxsta can do in around three minutes. 'To date, much of the focus has been on smaller-scale assessments of Roxsta, ensuring the results are accurate and the device is capable of being deployed in a commercial setting,' CEO Dr David Ali says. Memphasys shares gained 40% – or two-tenths of a cent – this morning. Robot says 'yes' on the best drug combos Why carry out expensive drug trials if a robot can do the job instead? We're being a tad facetious, but minnow Algorae Pharmaceuticals (ASX:1AI) highlights the potential for artificial intelligence to short-cut the initial stages of drug development. Algorae has partnered with the Victorian Centre for Functional Genomics, an arm of Melbourne's Peter MacCallum Cancer Centre, to validate AI-predicted drug interactions in oncology. Alogorae has developed AlgoraeOS, a machine learning tool to identify the best drug combinations. The study will focus on 24 AI-generated drug candidates, which are tested for synergies across four cancer cell lines (glioblastoma, pancreatic, breast and prostate). The company expects to release preclinical data within six months.
