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Asia

Telix Pharmaceuticals Says US FDA Approves New Drug Application for Brain Cancer Imaging Drug

Telix Pharmaceuticals (ASX:TLX) said the US Food and Drug Administration (FDA) approved its new drug application for Pixclara, or floretyrosine F 18, an amino acid positron emission tomography drug for imaging gliomas, according to a Monday Australian bourse filing.Pixclara is designed to differentiate recurrent or progressive glioma from treatment-related change along with other diagnostic evaluations.

ASX:TLX
Asia

ASX Biggest Losers

Here are the ASX-listed companies with the biggest losses on Friday.Develop Global (ASX:DVP): -11%, AU$4.77Liontown (ASX:LTR): -9%, AU$1.06Deep Yellow (ASX:DYL): -9%, AU$1.43Paladin Energy (ASX:PDN): -9%, AU$10.33Capstone Copper (ASX:CSC): -9%, AU$14.50PLS Group (ASX:PLS): -8%, AU$4.48GQG Partners (ASX:GQG): -7%, AU$1.12Telix Pharmaceuticals (ASX:TLX): -7%, AU$15.55Westgold Resources (ASX:WGX): -7%, AU$5.44Sandfire Resources (ASX:SFR): -7%, AU$20.91

ASX 200ASX:CSCASX:DVPASX:DYLASX:GQGASX:LTRASX:PDNASX:PLSASX:SFRASX:TLXASX:WGX
Asia

ASX Biggest Gainers

Here are the ASX-listed companies with the biggest gains on Thursday.Southgold 2 (ASX:SX2): +8%, AU$12.27Phylogica (ASX:PYC): +7%, AU$2.61OrezOne (ASX:ORE): +6%, AU$2.75Block (ASX:XYZ): +5%, AU$113.81Telix Pharmaceuticals (ASX:TLX): +5%, AU$16.44Kingsgate Consolidated (ASX:KCN): +4%, AU$5.39Deep Yellow (ASX:DYL): +4%, AU$1.61Resolute Mining (ASX:RSG): +4%, AU$1.44Perseus Mining (ASX:PRU): +4%, AU$6.66Life360 (ASX:360): +4%, AU$19.92

ASX:360ASX:DYLASX:KCNASX:OREASX:PRUASX:PYCASX:RSGASX:SX2ASX:TLXASX:XYZ
Asia

Telix Pharmaceuticals Completes Patient Enrollment in Phase Three Study of PSMA-PET Imaging Agents for Prostate Cancer Imaging

Telix Pharmaceuticals (ASX:TLX) completed patient enrollment in the phase three BiPASS study of its prostate-specific membrane antigen positron emission tomography (PSMA-PET) imaging agents Gozellix and Illuccix for prostate cancer imaging in the pre-biopsy setting, with 350 patients enrolled in the US and Australia, according to a Wednesday Australian bourse filing.The study seeks to evaluate whether the combination of magnetic resonance imaging and the imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography with Telix's proprietary gallium-68-PSMA-PET agents can improve diagnostic accuracy, reduce unnecessary biopsies, or improve targeting of biopsy compared with current standard practice.The firm also aligned with the US Food and Drug Administration on a new drug application pathway for BiPASS.Its shares rose nearly 1% in recent trading on Wednesday.

ASX:TLX
Asia

Telix Pharmaceuticals Appoints Chair

Telix Pharmaceuticals (ASX:TLX) appointed David Gill as chair, effective immediately, according to a Tuesday filing with the Australian bourse.Gill succeeds interim Chair Mark Nelson, who will remain on the board as a non-executive director, per the filing.

ASX:TLX
Asia

Telix Pharmaceuticals Logs Profit in H1; Revenue Up

Telix Pharmaceuticals (ASX:TLX) logged $0.1074 in EPS from continuing operations for the first half, compared with a loss of $0.0068 a year ago, a Thursday filing showed.For the six months ended June 30, revenue from contracts with customers was $477.4 million versus $390.4 million previously, the Australia-listed pharmaceutical company added. Analysts surveyed by FactSet expected $479.6 million.The company said it is on track to deliver in line with the upper end of its 2026 revenue guidance of $950 million to $970 million.

ASX:TLX
Asia

ASX Biggest Gainers

Here are the ASX-listed companies with the biggest gains on Friday.Mineral 260 (ASX:MI6): +10%, AU$0.80Light & Wonder CDI (ASX:LNW): +7%, AU$126.43Iluka Resources (ASX:ILU): +7%, AU$7.25Pilbara Minerals (ASX:PLS): +6%, AU$4.57Telix Pharmaceuticals (ASX:TLX): +6%, AU$15.89Liontown Resources (ASX:LTR): +6%, AU$1.14Predictive Discovery (ASX:PDI): +6%, AU$0.77West African Resources (ASX:WAF): +5%, AU$3.49James Hardie Industries (ASX:JHX): +5%, AU$42.78Neuren Pharmaceuticals (ASX:NEU): +4%, AU$22.52

ASX 200ASX:ILUASX:JHXASX:LNWASX:LTRASX:MI6ASX:NEUASX:PDIASX:PLSASX:TLXASX:WAF
Asia

Telix Says Thyroid Cancer Therapy Candidate Shows Encouraging Disease Control, Acceptable Safety Profile in Real-World Data Review

Telix Pharmaceuticals (ASX:TLX) said Friday long‑term clinical outcomes in an investigator‑led study evaluating fibroblast activation protein (FAP)-targeted therapy candidate, TLX400‑Tx, showed disease control rate of 80% based on the Response Evaluation Criteria in Solid Tumors, an acceptable safety profile, and preliminary efficacy signals in medullary thyroid cancer.A retrospective analysis of real-world data demonstrated a partial response rate of 33% and stable disease in 47% of patients, the company said in a statement. The median progression-free survival was 26 months, and the median overall survival was 42 months, with no dose-limiting toxicities detected.The outcomes from the study of 17 evaluable patients with progressive, locally advanced, or metastatic medullary thyroid carcinoma were published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Research.Most of the patients had received prior systemic therapies, Telix said. They received a median of five cycles of TLX400-Tx, with a subset also receiving tandem lutetium-177/225Ac-DOTAGA.Glu.FAPi dimer therapy.The company's shares fell past 1% in recent trading on Friday.

ASX:TLX
Asia

Telix Pharmaceuticals Carries Meaningful Upside on Potential Product Approvals, Jefferies Says

Telix Pharmaceuticals (ASX:TLX) stands to deliver meaningful investment upside and gain significant market share if it can secure regulatory approval for products in the development pipeline, Jefferies said in a Tuesday note.The company launched a prospective phase 3 study to evaluate TLX250-Tx as a potential radiotherapy for relapsed or recurrent clear cell renal cell carcinoma, with the first part of the study expected to enroll up to 40 patients.Following the progression to phase 3, Jefferies' risk-weighting for the trial increased to around 61% from about 21%, while the net present value for the opportunity moved to AU$2.13, the investment firm said.Jefferies raised its full-year 2026 net profit after tax forecast for Telix Pharmaceuticals to $10.6 million from $5.1 million after the company reported second-quarter revenue of $247 million. Telix also guided for 2026 operating revenue to be toward the top end of its $950 million to $970 million forecast range.The equity research firm maintained a buy rating on Telix Pharmaceuticals while raising the price target to AU$29 from AU$27.40.

ASX:TLX
Asia

Australian Shares Flat; NEXTDC Reports 11% Increase in Pro Forma Contracted Utilization

Australian shares were again flat on Tuesday after oil prices eased from a one-month high point on reports of potential de-escalation in the Middle East conflict.The S&P/ASX 200 Index was little changed to close at 8,793.30.Brent crude oil futures fell nearly 1% to trade around $88 per barrel. An Iranian official said the country had received a proposal from mediators for a 10-day ceasefire, Reuters reported. This was despite the Houthis in Yemen saying they would impose a naval blockade on major oil producer Saudi Arabia.Spot gold rose nearly 1% to $4,045.65 per ounce.On the domestic front, the ANZ-Roy Morgan Australian consumer confidence rose 0.3 points to 75.6 in the week of July 13 to July 19, ANZ reported.Australian consumer confidence edged higher last week, with improved sentiment around major household purchases largely offset by "weaker confidence in personal finances and the economic outlook," according to ANZ economist Sophia Angala.In company news, NEXTDC's (ASX:NXT) pro-forma contracted utilization increased 11% since April 20 to 740 megawatts as of June 30 following additional customer contract awards. The company's pro forma forward order book increased to 565 megawatts due to contract wins.Telix Pharmaceuticals (ASX:TLX) reported second-quarter revenue rose 21% to $247 million due to strong sale of precision medicine category. The company expects fiscal 2026 income to track in line with the upper end of the outlook of $950 million to $970 million.Lastly, PYC Therapeutics (ASX:PYC) said autosomal dominant optic atrophy (ADOA) patients in the ongoing clinical trials of its PYC-001 drug candidate showed sustained improvement in both visual acuity and retinal stress following repeat doses.

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Asia

Update: Telix Pharmaceuticals Posts Higher Q2 Revenue; Shares Rise 3%

(Updates to add stock movement in the last paragraph)Telix Pharmaceuticals (ASX:TLX) reported second-quarter revenue rose 21% to $247 million due to strong sale of precision medicine category, according to a Tuesday filing with the Australian bourse.The company expects fiscal 2026 revenue and other income to be more than $1 billion, with income tracking in line with the upper end of the outlook of $950 million to $970 million.It increased its fiscal 2026 research and development expenditure outlook to $230 million to $270 million from the prior range of $200 million to$240 million.The company's shares rose 3% in recent Tuesday trade.

ASX:TLX
Asia

ASX Preview: Australian Shares to Fall as Oil Gains on Middle East Tensions; Telix Pharmaceuticals Posts Higher Q2 Revenue

Australian shares are poised to fall on Tuesday as oil prices rose more than 1% after Yemen's Houthis imposed a naval blockade on Saudi Arabia, while investors weighed hopes of renewed US-Iran negotiations.Overnight, the S&P 500, the Nasdaq Composite, and the Dow Jones Industrial Average fell 0.2%, 0.1%, and 0.6%, respectively.In the macroeconomy, the ANZ-Roy Morgan Australian consumer confidence rose 0.3 points to 75.6 in the week of July 13 to July 19, ANZ reported Tuesday.In corporate news, Telix Pharmaceuticals (ASX:TLX) reported second-quarter revenue rose 21% to $247 million due to strong sale of precision medicine category.HUB24 (ASX:HUB) reported total funds under administration rose 20% to AU$164.3 billion as at June 30.Australia's benchmark index was little changed to close at 8,791.30 on Monday.

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Asia

Telix Pharmaceuticals Posts Higher Q2 Revenue

Telix Pharmaceuticals (ASX:TLX) reported second-quarter revenue rose 21% to $247 million due to strong sale of precision medicine category, according to a Tuesday filing with the Australian bourse.The company expects fiscal 2026 revenue and other income to be more than $1 billion, with income tracking in line with the upper end of outlook of $950 million to $970 million.It increased its fiscal 2026 research and development expenditure outlook to $230 million to $270 million from prior range of $200 million to$240 million.

ASX:TLX
Asia

Telix Pharmaceuticals Completes Phase Three Enrollment for Prostate Cancer Imaging Study in Japan

Telix Pharmaceuticals (ASX:TLX) has completed enrollment of 105 patients in its phase three registration study of TLX591-Px, a prostate cancer imaging agent, in Japan, according to a Friday statement by the company.The study will generate clinical data to support a new drug application submission to Japan's Pharmaceuticals and Medical Devices Agency, seeking approval for the use of the product in detecting metastatic lesions in patients with recurrent prostate cancer.The company's shares fell 2% in recent Friday trade.

ASX:TLX
Asia

Telix Pharmaceuticals Opens Radiopharmaceutical Research, Manufacturing, Treatment Facility in Melbourne

Telix Pharmaceuticals (ASX:TLX) opened a multi-million dollar radiopharmaceutical research, manufacturing, and treatment facility in Melbourne, described as a "first-of-its-kind" Australian purpose-built site, the company said in a statement Thursday.The company said the facility combines radiochemistry laboratories, clinical product manufacturing, patient dose administration, and imaging under one roof.The company's shares fell nearly 2% in recent Thursday trade.

ASX:TLX
Asia

Telix Pharmaceuticals Doses First Patients in Phase Two Trial for Prostate Cancer Therapy

Telix Pharmaceuticals (ASX:TLX) and St Vincent's Hospital have dosed the first patients in the phase two Optimal-e trial evaluating the investigational radioligand therapy TLX597-Tx in patients with metastatic hormone-sensitive prostate cancer, according to a Thursday statement by the company.The open-label study is evaluating adaptive dosing of TLX597-Tx in combination with androgen deprivation therapy and an androgen receptor pathway inhibitor using PSMA-PET imaging and prostate-specific antigen (PSA) levels to personalize treatment according to each patient's response.The study will evaluate the impact of TLX597-Tx on PSA response rate, depth, and durability in an earlier treatment setting while further assessing the safety of dose intensification.TLX597-Tx is an investigational therapy that has not received marketing approval in any jurisdiction, the company added.

ASX:TLX
Asia

ASX Biggest Losers

Here are the ASX-listed companies with the biggest losses on Friday.Electro Optic Systems Holdings (ASX:EOS): -6%, AU$8.38Pro Medicus (ASX:PME): -5%, AU$199.56Tamboran Resources (ASX:TBN): -4%, AU$0.23Elevra Lithium (ASX:ELV): -4%, AU$8.67Austal (ASX:ASB): -4%, AU$3.77EVT (ASX:EVT): -3%, AU$12.33Telix Pharmaceuticals (ASX:TLX): -3%, AU$16.36Marimaca Copper (ASX:MC2): -3%, AU$7.51SiteMinder (ASX:SDR): -3%, AU$3.79Codan (ASX:CDA): -3%, AU$43.25

ASX 200ASX:ASBASX:CDAASX:ELVASX:EOSASX:EVTASX:MC2ASX:PMEASX:SDRASX:TBNASX:TLX
Asia

Telix Pharmaceuticals Securing FDA Nod in Line With Expectations, Says Jefferies, Shares Down 3%

Telix Pharmaceuticals (ASX:TLX) reaching alignment with the US Food and Drug Administration (FDA) to advance a phase 3 trial of its TLX591-Tx therapeutic candidate is in line with expectations, according to a Thursday Jefferies note.The company said on Thursday that the US regulator confirmed that safety data from part one of the study is adequate to allow for the progression of part two.Jefferies added that the update results in no changes to forecasts or the price target for Telix Pharmaceuticals.Jefferies kept a buy rating on Telix with a price target of AU$27.40.The company's shares fell 3% in recent Friday trade.

ASX:TLX
Asia

Telix Pharmaceuticals Gets US FDA Nod to Advance Phase 3 Prostate Cancer Trial

Telix Pharmaceuticals (ASX:TLX) reached alignment with the US Food and Drug Administration (FDA) to advance a phase 3 trial of its TLX591-Tx therapeutic candidate in metastatic castration-resistant prostate cancer, the company said Thursday.In a type B meeting, the US regulator confirmed that safety data from part one of the study is adequate to allow for progression of part two, the company said.The launch of part two in the US remains subject to the FDA's review of an investigational new drug amendment, per the statement.

ASX:TLX
Asia

ASX Biggest Gainers

Here are the ASX-listed companies with the biggest gains on Wednesday.Wisetech Global (ASX:WTC): +13%, AU$32.51BCI Minerals (ASX:BCI): +11%, AU$0.42Anteris Technologies (ASX:AVR): +10%, AU$14.99Xero (ASX:XRO): +8%, AU$70.31Telix Pharmaceuticals (ASX:TLX): +7%, AU$15.54Neuren Pharmaceuticals (ASX:NEU): +5%, AU$12.99Tasmea (ASX:TEA): +5%, AU$9.45Lindian Resources (ASX:LIN): +5%, AU$0.92Regis Healthcare (ASX:REG): +4%, AU$6.53Iluka Resources (ASX:ILU): +4%, AU$7.54

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