Latest news with #Pixclara
AU Financial Review
28-04-2025
- Business
- AU Financial Review
Telix setback in drug approval in US, amid Trump workforce cuts to FDA
Telix Pharmaceuticals says it is disappointed by a surprise US Food and Drug Administration decision to ask for more clinical evidence to support approval for its brain cancer imaging agent, a rare setback for the $9 billion ASX-listed diagnostic giant. Telix shares fell as much as 10 per cent in early trading on Monday after the FDA said it would not approve the company's diagnostic tool called Pixclara, which identifies gliomas, a deadly form of brain cancer, until the company provided additional evidence about its benefits.
News.com.au
28-04-2025
- Business
- News.com.au
Health Check: Telix licks its wounds after FDA knocks back brain cancer diagnostic
The FDA has told Telix to do more work on its imaging agent for rare brain cancers But the agency tells Dimerix it can use a surrogate endpoint for its kidney disease drug candidate Emvision opens a second US site to test its stroke detection tool Telix Pharmaceuticals (ASX:TLX) will seek a 'please explain' from the US Food & Drug Administration (FDA) after the agency rejected the company's marketing approval application for its brain cancer (glioma) diagnostic tool, Pixclara. The shock news sent Telix shares down as much as 10% this morning. 'This was obviously a disappointing outcome and not what was expected by the company,' said Telix CEO Dr Chris Behrenbruch. In a so-called complete response letter (CRL), the agency said the entreaty could not be approved without 'additional confirmatory clinical evidence'. Pixclara – TLX101-CDx – is a nuclear imaging agent for glioma, a rare and life-threatening brain cancer. Currently the FDA has not approved any targeted PET (positive emission tomography) agents for brain cancer imaging. This is despite the technology underlying Pixclara (PET-FET) being used widely elsewhere. Blindsided The company is baffled because the FDA reviewers did not raise any concerns in the lengthy consultation process. The issues appeared to emerge at the late stage, when the parties discussed specific product labelling. The FDA already had granted orphan drug and fast-track designation to Pixclara, which has been used in early access programs on compassionate grounds. Choosing his words carefully, Behrenbruch said he believed the decision reflected 'a change of culture' at the FDA over the last few months. 'We don't think it's a decision that reflects the scientific merit or patient risk benefit of the data,' he told a webinar this morning, adding the parties seemed clear on the data that would be used. He was not suggesting the FDA had become 'less scientifically led', but there was 'less flexibility than we had seen previously towards the back end of the process'. Behrenbruch says Telix has several options to address the CRL concerns, including re-analysing existing (undisclosed) data, or carrying out additional clinical trials. Put in context, the FDA has approved two Telix prostate cancer diagnostics. The company is deriving strong revenues from the first, Illucix. Knock back should not affect kidney application One issue is the potential impact on the company's kidney imaging agent Zircaix, which the FDA currently is reviewing. Behrenbruch said Pixclara was filed under a more flexible and 'creative' process called the 505 (b2) pathway. 'The two should not be conflated,' he said. Given the accepted use of FET-PET elsewhere, the company did not back the Pixclara application with a definitive pivotal trial. 'Zircaix was based on two phase III trials, which far exceeded all their primary and secondary endpoints,' Behrenbruch said. 'We are dealing with a completely different submission process.' Telix estimates the US glioma opportunity at US$100-$140 million per year. Expanding to additional indications (such as brain metastases) could boost this market to US$475-665 million. Given Pixclara has not yet been approved, the the knock-back does not affect the company's current-year revenue guidance. Still, the episode sounds a warning to FDA applicants that everyone may no longer may be on the same page. Dimerix can adopt a surrogate The FDA has delivered Dimerix (ASX:DXB) cheerier news, deeming a so-called surrogate endpoint to be adequate to support potential marketing approval of its drug for a rare kidney disease. The endpoint is proteinuria – protein in the urine – a tell-tale sign the spuds are not working too well. A traditional endpoint such as patients' overall survival is problematic, because complete renal failure and death may not be evident for years. Dimerix is in phase III trial stage for focal segmental glomerular sclerosis, called Action 3, with an interim analysis showing DMX-200 reduced proteinuria after 35 weeks' treatment. Dimerix CEO Dr Nina Webster describes the FDA decree as an 'exceptional outcome, particularly given that DMX-200 has previously demonstrated positive effects on this endpoint in both pre-clinical and clinical studies.' The company says 183 out of 286 intended patients have been dosed in the Action 3 study, with results expected next year. The FDA also remains 'open to discussion' on endpoints that could support accelerated approval. Pacific Edge fights for pay despite adverse US ruling Kiwi diagnostics house Pacific Edge (ASX:PEB) says it will continue to fight for restoration of US Medicare reimbursement for its bladder cancer tests, despite a legal setback. Last week a Pennsylvania District Court judge ruled that her court lacked jurisdiction to hear Pacific Edge's claim against Novitas – the relevant Medicare contractor – and the Center of Medicare and Medicaid (CMS). Mind you the beak in question, Judge Keli M. Neary, noted the company had marshalled 'incredibly compelling facts for why its test is a medical marvel'. Pacific Edge's lobbying efforts have been in vain, despite heavyweight support from the American Urological Association (AUA). Reimbursement expired on April 24. The company's Cxbladder test cover detection and triaging of patients and ongoing monitoring. Pacific Edge now intends to appeal to the Medicare system, arguing its triage tool is included in AUA clinical guidelines. It will also pursue coverage for is monitoring tool, but not the detection product as 'no new evidence has been published that can be submitted for reconsideration.' Pacific Edge derives 60% of its US revenue from Medicare – and most of its overall revenue from Trumpland – so it's no small beer. Pacific Edge CEO Dr Peter Meintjes says the 'flawed process … failed to review the most-current evidence.' On the bright side, Pacific Edge expects to receive uninterrupted reimbursement from contracted commercial US payers, including US Veterans Administration. Mayo-my as Emvision opens second trial site Emvision has added a second US site for its pivotal trial of its portable stroke detection tool, at Mayo Clinic in Jacksonville, Florida. The company plans a site initiation visit and device training in early May. The Mayo site augments an existing one at the UTHealth and Memorial Hermann-Texas Medical Center. The trial aims for FDA clearance of Emu, a point-of-care brain scanner for early detection and classification of strokes. The company says additional US and Australian trial site will be 'announced and activated shortly'. Percheron board survives – again The Percheron Therapeutics (ASX:PER) board has survived a second spill attempt following December's failure of its flagship Duchenne muscular dystrophy (DMD) program. On Thursday the company said shareholders had voted against removing chairman Dr Charmain Gittleson, CEO James Garner and another director, by a margin of approximately 72-73%. Curiously, the requisitioning party, Powerhouse Ventures, had halved its stake ahead of the meeting, to just over 5%. To use a timely political analogy, the board enjoyed a swing in its favour. In March another ginger group failed to eject chairman Gittleson and Garner, by a margin of 55-56% . 'It is now time to put these disputes behind us and focus our entire efforts on the vital task of restoring value for shareholders,' Gittleson says. With the DMD program dead, buried and cremated, the board plans to use the company's remaining cash to acquire an alternative program.
News.com.au
23-04-2025
- Business
- News.com.au
Health Check: Telix shares rocket after bullish quarterly sales update
Telix's quarterly sales reflect first revenue from the company's recent purchase of a US nuclear medicine manufacturer Island Pharma hopes to lift the kimono on its dengue fever trial next month Race Oncology kicks off its cancer-busting, cardioprotective trial Having gleaned all its revenue to date from its US-approved prostate cancer imaging agent Illucix, Telix Pharmaceuticals (ASX:TLX) is starting to reap the benefit of its acquisition of a US nuclear medicine manufacturer. In September last year Telix paid US$230 million for RLS Radiopharmacies, which has 31 nuclear pharmacies dotted across Trumpland. Telix has reported March quarter revenue of US$186 million, 62% higher year on year and 31% up on the December quarter. This includes a robust US$33 million from RLS, which Telix formally acquired on January 27 this year. 'This strategic acquisition has significantly expanded our manufacturing footprint in the US, which we believe is an increasingly important consideration amid changing global trade dynamics,' says Telix chief Dr Chris Behrenbruch. Ah, tariffs! We get it. Illucix sales continue at a decent clip: US$151 million, up 35% year on year. 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape,' Behrenbruch says. Telix has affirmed guidance of full-year (calendar 2025) revenue of US$770-800 million, including eleven months of RLS sales. The guidance is subject to change, given the US Food and Drug Administration (FDA) on March 21 approved Telix's second diagnostic, Gozellix (also for prostate cancer). Telix hopes to launch Gozellix in the US in the current quarter, having appointed RLS and Cardinal Health as distribution partners. Bursting development pipeline Meanwhile, Telix expects FDA approval for its brain imaging candidate Pixclara by the end of this week – April 26. As per the FDA's timetable, the agency should approval Telix's kidney cancer imaging candidate Zircaix by August 27. Investors should expect an initial safety and dosing readout on phase III trial results for Telix's prostate cancer therapy (as opposed to diagnostic) in the current half. Telix also hopes to submit an FDA investigational new drug application for its kidney cancer therapeutics, in view of a late-stage pivotal trial. Adding to Telix's packed agenda, the company has earlier stage programs for a brain cancer therapy (phase II) and advanced, metastatic soft tissue sarcoma (phase I). Telix shares this morning rocketed as much as 15%, but they are still well shy of their February 25 zenith of just over $31. Investors may question just how much of the excitement is factored into Telix's $9.7 billion market capitalisation. Island promises trial results next month Island Pharmaceuticals (ASX:ILA) investors won't have to wait too much longer for results from the second stanza of the company's phase 2a/b dengue fever trial. The 2a phase assessed the preventative qualities of Island's drug candidate ISLA-101 in four undiseased subjects, one of whom was administered a placebo. The drug was deemed safe, with 'evidence of anti-dengue activity". The 2b stage had enrolled ten patients who are administered a weakened form of the virus. Eight of them are administered ISLA-101, with two receiving a placebo. Pharmacokinetic tests showed the drug reached the bloodstream in desired quantities. Next month's results will outline the efficacy. Carried by mosquitos, dengue fever has become a major health problem as it spreads at a rate that makes cane toads look slothful. Race to start cancer trial Race Oncology (ASX:RAC) expects to treat the first patient in its local phase 1 trial that tests its drug candidate RC-220 alongside a common chemotherapy agent. RC-220 is a reformulated version of bisantrene, which was developed as a leukemia drug in France in the 1980s, but was never commercialised for reasons lost in the midst of time. RC-220 shows promise not just for its cancer-busting properties, but its ability to protect the heart from the dire effects of chemotherapy. The trial custodians are treating initial patients at the Southside Cancer Care Centre at Sydney's Miranda. Race has also gained ethics approval to open sites at the Gosford and Wyong hospitals. Race's March quarterly report discloses cash of $17.12 million, with 70% of the $1.67 million quarterly burn devoted to R&D. 'This prudent cash management enables Race to fund all announced clinical and preclinical programs through calendar 2026," the company says. Race costs the circa 53-patient RC-220 trial at $8.58 million. An FDA decision to dye for The latest decision by US health czar Robert F. Kennedy Junior and FDA commissioner Marty Makary could be one of their least controversial. The FDA has banned petroleum-based synthetic dyes from food, as used sweets, soft drinks and other stuff that isn't good for you. Depending on their colour, dyes are thought to be carcinogenic or cause behavioural problems in some children. One of President Biden's last acts in power was to ban an especially controversial red dye from food and ingested drugs, after the additive was found to cause cancer in rats. Technically, the dye no longer is 'generally recognised as safe'.
