ASX biotech expands diagnostics portfolio after FDA approval

Morning Star AU09-16 00:00

Telix Pharmaceutical’s (ASX.TLX) Pixclara becomes the first positron emission tomography, or PET, imaging agent for glioma brain cancer to receive approval from the US Food and Drug Administration.Why...

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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nASX biotech expands diagnostics portfolio after FDA approval\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-09-16 00:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.morningstar.com.au/stocks/asx-biotech-expands-diagnostics-portfolio-after-fda-approval><strong>Morning Star AU</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Telix Pharmaceutical’s (ASX.TLX) Pixclara becomes the first positron emission tomography, or PET, imaging agent for glioma brain cancer to receive approval from the US Food and Drug Administration.Why...</p>\n\n<a href=\"https://www.morningstar.com.au/stocks/asx-biotech-expands-diagnostics-portfolio-after-fda-approval\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"FRTY","symbol_name":"Alger Mid Cap 40 ETF","start_time":0,"source_url":"https://www.morningstar.com.au/stocks/asx-biotech-expands-diagnostics-portfolio-after-fda-approval","article_id":"2667671746","we_media_id":null,"thumbnails":[],"rights":{"source":"morningstar_stock","url":"https://www.morningstar.com.au/stocks/asx-biotech-expands-diagnostics-portfolio-after-fda-approval","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2667671746","pubTimestamp":1789488000,"columns":[],"sourceInfo":{"source_id":"morningstar_stock","name":"Morning Star"},"weMediaInfo":null,"summary":"Telix Pharmaceutical’s (ASX.TLX) Pixclara becomes the first positron emission tomography, or PET, imaging agent for glioma brain cancer to receive approval from the US Food and Drug Administration.Why","collect":0,"end_time":0,"defaultTopTitle":"morningstar.com.au","property":[],"viewcount":null,"language":"en","relate_stocks":{"FRTY":"Alger Mid Cap 40 ETF","MRNY":"MRNA期权收益策略ETF-YieldMax","MEDI":"HARBOR HEALTH CARE ETF","BK4588":"碎股","IEIH":"iShares Evolved U.S. Innovative Healthcare ETF","PINK":"SIMPLIFY HEALTH CARE ETF","TBXU":"Direxion Daily Biotech Top 5 Bull 2X ETF","LFSC":"F/m Emerald Life Sciences Innovation ETF","RSPH":"Invesco S&P 500 Equal Weight Health Care ETF","IBB":"生物科技指数ETF-iShares Nasdaq","BK4585":"ETF&股票定投概念","LABU":"三倍做多标普生物-Direxion","IDNA":"iShares Genomics Immunology and Healthcare ETF","PSCH":"Invesco S&P SmallCap Health Care ETF","GDOC":"Goldman Sachs Future Health Care Equity ETF","BMED":"iShares Health Innovation Active ETF","IYH":"iShares U.S. Healthcare ETF","XLVX":"Corgi U.S. Healthcare 2x Daily ETF","GNMX":"Corgi Genomics & Precision Medicine ETF","TECB":"iShares U.S. Tech Breakthrough Multisector ETF","BBP":"Virtus LifeSci Biotech Products ETF","XBIX":"Corgi U.S. Biotech 2x Daily ETF","NVIB":"Direxion NVDA Defined Income Boost ETF","MRNX":"Defiance Daily Target 2X Long MRNA ETF","SYNB":"PUTNAM BIOREVOLUTION ETF"},"translate_title":"ASX biotech 在 FDA 批准后扩大诊断产品组合","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LABU":1.5,"TECB":1.5,"FRTY":1.5,"IEIH":1.5,"GNMX":1.5,"SYNB":1.5,"GDOC":1.5,"IDNA":1.5,"TBXU":1.5,"RSPH":1.5,"BBP":1.5,"MRNX":0.6,"PINK":1.5,"IBB":1.5,"PSCH":1.5,"MRNY":1.5,"MEDI":1.5,"NVIB":1.5,"IYH":1.5,"BMED":1.5,"XLVX":1.5,"LFSC":1.5,"XBIX":1.5},"content_text":"Telix Pharmaceutical’s (ASX.TLX) Pixclara becomes the first positron emission tomography, or PET, imaging agent for glioma brain cancer to receive approval from the US Food and Drug Administration.Why it matters: We had anticipated the FDA approval for Pixclara, which now adds another commercialized product to Telix’s precision medicine portfolio. The addressable market is smaller than Telix’s current flagship products of Illuccix and Gozellix, given glioma’s lower incidence than prostate cancer. However, there are currently no FDA-approved products in the US for imaging gliomas, the most common type of brain cancer, accounting for 30% of all tumors and 80% of malignant tumors.The current standard diagnosis tool is MRI scans. However, they alone cannot reliably distinguish between tumor growth and inflammation caused by treatment. Pixclara addresses this through PET imaging.The bottom line: Our earnings forecasts remain intact as they already assume first sales of Pixclara in 2026 and forecast pricing to be similar to other fluorine-18 imaging agents. As such, we maintain our $18.50 fair value estimate for no-moat Telix. Shares remain modestly undervalued.Shares rose around 4% in response to the FDA decision, suggesting consensus had also partially anticipated the outcome. Attention now moves to other drugs in the pipeline, notably the resubmission of Zircaix, an imaging agent for kidney cancer, which is likely to occur within the next few months.The pipeline also includes therapeutics or treatment drugs for brain, kidney, and prostate cancer. The most notable is TLX591, a therapeutic for advanced metastatic prostate cancer. We assume a 25% probability of its successful commercialization, with first sales in 2029.Telix Pharmaceuticals: Strong revenue growth, with upcoming resubmission for ZircaixTelix’s strategy revolves around expanding its Illuccix distribution and investing in its product pipeline. Illuccix launched in April 2022 and was the second commercially available PSMA imaging agent for prostate cancer. It has gained significant market share due to changes in clinical practice and successful distribution. Currently, Illuccix is mainly used for staging suspected metastatic prostate cancer, which determines how far the cancer has spread beyond the prostate. If the cancer is in the early stage, this may be redundant. The adoption of Illuccix is also growing for suspected recurrence, monitoring, and patient selection for radioligand therapy. Telix has several distribution partners, including Cardinal Health, who operate the largest radiopharmaceutical network in the US and effectively distribute Illuccix to PET imaging sites.The firm invests heavily in research and development. In the near term, the company aims to receive regulatory clearances for two new imaging agents, Zircaix for kidney cancer and Pixclara for brain cancer. Zircaix targets a cell-surface antigen expressed in clear cell renal cell cancer, or ccRCC, but absent from normal kidney tissues. Telix received exclusive global rights for Zircaix from Wilex in 2017. Pixclara aims to differentiate pseudoprogression from true progression in gliomas, or brain tumors, in a single scan. The current standard of care is multiple magnetic resonance imaging scans.The firm is conducting various clinical trials, the most significant being TLX591. We anticipate an interim readout of its phase 3 trial in 2026 and a potential launch by 2029 after assessment of final results, preparation for lodgment, and receipt of regulatory approvals. Novartis’ Pluvicto was the first targeted radioligand therapy for PSMA-positive metastatic prostate cancer to receive regulatory approval in March 2022. However, Telix estimates the cost to manufacture TLX591 to be 20% of Pluvicto’s cost due to the latter’s wasted radiation. TLX591 is more targeted and only needs a fraction of Lutium-177, which affects radiation waste and patient management.Bulls SayIlluccix has gained significant market share due to changes in clinical practice and successful distribution.The company requires minimal capital and is expected to generate very high returns as it continues to expand its distribution.Telix aims to receive approvals for additional radiopharmaceuticals for use in prostate, renal, and brain cancer.Bears SayThere is high uncertainty on the continued success of Illuccix and timing and adoption of its product pipeline.There appears to be no significant switching costs for doctors to adopt competing products.Average selling prices of Illuccix are under pressure after its transitional pass-through payment status expired in 2025.Subscribe to get Morningstar insights in your inbox","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.50.0","shortVersion":"4.50.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2667671746","isCrawlerRequest":true}